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{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nThe Role of Multi-Modality Therapy for the Treatment of High-Grade Soft Tissue Sarcomas of the Extremities\n\n**Clinical Trial Summary:**\n\nPatients with Grade II and III soft tissue sarcomas of the extremity will be randomized to either receive or not receive radiation therapy following surgery for the removal of the local tumor. All patients in this protocol will receive adjuvant chemotherapy.\n\n**Clinical Trial Detailed Description:**\n\nPatients with Grade II and III soft tissue sarcomas of the extremity will be randomized to either receive or not receive radiation therapy following surgery for the removal of the local tumor. All patients in this protocol will receive adjuvant chemotherapy.\n\n**Clinical Trial Eligibility Criteria:**\n\nPatients must have biopsy-proven soft tissue sarcoma with one of the following diagnoses:\n Liposarcoma (round cell or pleomorphic).\n Fibrosarcoma.\n Malignant fibrous histiocytoma.\n Inflammatory malignant fibrous histiocytoma.\n Myxoid malignant fibrous histiocytoma.\n Malignant giant cell tumor.\n Angiomatoid malignant fibrous histiocytoma.\n Leiomyosarcoma.\n Malignant hemangiopericytoma.\n Rhabdomyosarcoma (embryonal, alveolar, pleomorphic or combined).\n Soft tissue sarcoma resembling Ewing's sarcoma.\n Synovial cell sarcoma.\n Epithelioid sarcoma.\n Clear cell sarcoma.\n Neurofibrosarcoma.\n Epithelioid schwannoma.\n Malignant triton tumor.\n Angiosarcoma.\n Mixed malignant mesenchymoma.\n Alvelar soft part sarcoma.\n Malignant granular cell tumor.\n All lesions must be Grade II or III. No patients with Grade I lesions will be acceptable.\n Patients must have undergone a limb-sparing procedure in which all gross tumor has been removed.\n Clinical evaluation must reveal no evidence of metastatic disease either in regional lymph nodes or more distant sites.\n The soft tissue sarcoma must be on the extremity either at or distal to the shoulder joint or at or distal to the hip joint.\n The definitive surgical procedure for a primary lesion or for a recurrence must have been performed no longer than four months from the date of randomization.\n Patients must not have received any prior chemotherapy or radiotherapy for their sarcoma.\n Patients without a history of any other malignant disease except basal cell carcinoma.\n Patients who have not had a serious infection, active bleeding disorders, or concomitant severe disease such as cirrhosis, ischemic heart disease, or evidence of severe impairment of renal function.\n Patients must be above the age of 30 and do not have a diagnosis of embryonal rhabdomyosarcoma.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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1
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nThe Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors\n\n**Clinical Trial Summary:**\n\nPatients with Grade I soft tissue sarcomas or benign, non-metastasizing invasive soft tissue tumors will receive wide local excision and be prospectively randomized as to either receive or not receive radiation therapy.\n\n**Clinical Trial Detailed Description:**\n\nThis is a randomized study. Patients undergo surgical excision of all gross disease and then are randomized to Arm I or Arm II.\n Arm I: Radiotherapy. Involved-field irradiation.\n Arm II: No further treatment.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n Biopsy-proven grade I soft tissue sarcoma or one of the following benign but highly invasive soft tissue tumors:\n Abdominal and extra-abdominal fibromatosis (desmoid,\n aggressive fibromatosis),\n Dermatofibrosarcoma protuberans,\n Intramuscular lipoma (infiltrating lipoma),\n Diffuse lipomatosis,\n Leiomyoma of deep soft tissue,\n Diffuse giant cell tumor of tendon sheath (proliferative synovitis).\n No clinical evidence of metastases in regional nodes or more distant sites.\n No primary intraperitoneal or retroperitoneal tumors.\n Resection of all gross tumor at the time of surgical excision required (margins may be pathologically positive or negative).\n No von Recklinghausen's disease.\n PRIOR/CONCURRENT THERAPY:\n Biologic Therapy: Not specified.\n Chemotherapy: No prior chemotherapy for sarcoma.\n Endocrine Therapy: Not specified.\n Radiotherapy: No prior radiotherapy for sarcoma.\n Surgery: No more than 4 months since definitive surgery for\n primary lesion or recurrence.\n No prior amputation.\n PATIENT CHARACTERISTICS:\n Age: 18 and over.\n Performance status: Not specified.\n Hematopoietic: Not specified.\n Hepatic: No cirrhosis.\n Renal: No evidence of severe renal impairment.\n Cardiovascular: No ischemic heart disease.\n OTHER:\n No prior malignancy except basal cell carcinoma.\n No serious infection.\n No active bleeding disorder.\n No severe concomitant disease.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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2
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients With CD4 <= 500 Cells/mm3\n\n**Clinical Trial Summary:**\n\nTo determine the effect of Viracept in combination with modified antiretroviral therapy on the outcome of cutaneous and mucosal Kaposi's Sarcoma (KS).\n\n**Clinical Trial Detailed Description:**\n\nThis is an open-label, randomized, pilot, Phase II study of the safety and efficacy of Viracept in combination with modified antiretroviral therapy as treatment in patients with cutaneous and mucosal KS. Patients will be randomized to modify (add or switch or initiate) their current antiretroviral therapy and will add Viracept or remain on their current background antiretroviral therapy for a 2 month period. Initially 20 patients will be randomized in a 2:1 ratio (i.e., 14 Viracept, 6 control) for a 2 month period. Response to therapy will be evaluated at the end of the 2 month control phase. At this point, patients who were initially assigned to the control arm will continue on open label Viracept for an additional 10 month period.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria\n Patients must have:\n - HIV-positivity.\n - Diagnosed KS proven by biopsy.\n - NOTE:\n - Patients must not opt for immediate topical, systemic or radiation treatment.\n - At least 4 cutaneous lesions not treated within the previous 4 weeks.\n - Life expectancy > 6 months.\n - Signed, informed consent from parent or legal guardian for those patients < 18 years of age.\n Exclusion Criteria\n Co-existing Condition:\n Patients with the following conditions and symptoms are excluded:\n - Neoplastic disease (excluding KS) requiring systemic cytotoxic or radiation therapy or who have had these therapies within 1 month of baseline and have not completely recovered from the effects of these therapies.\n - Unstable or severe intercurrent medical conditions, including but not limited to, significant symptomatic visceral KS.\n - Clinically significant malabsorption syndrome.\n - Renal insufficiency.\n Patients with any of the following prior conditions are excluded:\n Significant Fever (> 101 degrees F (38 degrees C) for >= 7 days) and/or diarrhea (> 6 loose stools/day for >= 7 days) within one month of baseline.\n 1. Immediate topical or systemic treatment for KS lesions.\n - Use of Retinoid class drugs, either topically or systemically, or beta-carotene compounds or Vitamin A doses of more than 15,000 IU (5,000 mcg) per day concurrently.\n Immediate radiation treatment.\n 1. Treatment of KS lesions with intra-lesional chemotherapy within 4 weeks of entry.\n - History of > 2 weeks of prior therapy with Indinavir or Ritonavir.\n - Use of Retinoid class drugs, either topically or systemically, or beta-carotene compounds or Vitamin A doses of more than 15,000 IU (5,000 mcg) per day within 4 weeks of entry.\n Treatment of KS lesions with radiation within 4 weeks of entry. Active substance abusers; urine drug tests may be performed if drug abuse is suspected.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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3
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nCombination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells.\n PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients with peripheral neuroectodermal tumors, Ewing's sarcoma, Wilms' tumor, or bone cancer.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the response rate and event-free survival of patients with peripheral primitive neuroectodermal tumors or Ewing's sarcoma treated with cyclophosphamide, doxorubicin, vincristine, etoposide, and ifosfamide, followed by surgery (if feasible) and radiotherapy. II. Determine the response to a uniform treatment regimen in order to clarify whether these disease categories each have a different prognosis.\n OUTLINE: Patients are stratified according to disease category (primitive neuroectodermal tumor vs Ewing's sarcoma). Patients receive treatment on regimen A as outlined below during courses 1-3 and 6 and regimen B as outlined below during courses 4, 5, and 7 in the absence of disease progression or unacceptable toxicity. Each course lasts 3-4 weeks. Patients without metastatic disease after completion of course 3 undergo complete tumor resection, if feasible. Patients achieving complete response with or without microscopic residual disease after completion of course 7 undergo radiotherapy twice daily, 5 days a week, for 3 weeks. Patients with gross residual disease after completion of course 7 undergo radiotherapy twice daily, 5 days a week, for 3.6 weeks. Regimens A and B are defined below: Regimen A: Patients receive cyclophosphamide IV over 6 hours on days 1 and 2, doxorubicin IV continuously and vincristine IV continuously on days 1-3, and vincristine IV on day 9. Regimen B: Patients receive etoposide IV over 1 hour, followed immediately by ifosfamide IV over 1 hour on days 1-5. Patients are followed monthly for 18 months and then every 6 months for 18 months.\n PROJECTED ACCRUAL: A maximum of 50 patients (25 per stratum) will be accrued for this study within 5 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Diagnosis of peripheral primitive neuroectodermal tumor, including peripheral neuroepithelioma or Askin tumor OR Diagnosis of localized or metastatic Ewing's sarcoma, including the following: Unresectable or metastatic small cell osteosarcoma Unresectable or metastatic other nonrhabdomyosarcomatous soft-tissue sarcomas Unresectable or metastatic other non-osteosarcomatous bone sarcomas Desmoplastic small round-cell tumor Metastatic or non-metastatic Wilms' tumor Immunocytochemistry, electron microscopy, and/or chromosomal analysis may be required to rule out other small round cell neoplasms\n PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified\n PRIOR CONCURRENT THERAPY: Not specified\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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4
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nSurgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether giving chemotherapy after surgery is more effective than surgery alone in treating soft tissue sarcoma.\n PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients who have soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Compare the local disease control, overall survival, and relapse-free survival in patients with high-grade soft tissue sarcoma treated with adjuvant high-dose doxorubicin and ifosfamide plus filgrastim (G-CSF) vs no adjuvant chemotherapy and G-CSF after definitive surgery.\n - Compare the toxicity and morbidity of these regimens in these patients.\n OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, site of primary tumor (extremity vs trunk, including shoulder, pelvic girdle, head, or neck vs central, including intrathoracic, visceral, uterine, or retroperitoneal), size of primary tumor (less than 5 cm vs 5 cm or greater in largest diameter), postoperative radiotherapy (yes vs no), and isolated limb perfusion therapy (yes vs no).\n Some patients undergo isolated limb perfusion therapy with cytotoxics and/or cytokines.\n No more than 8 weeks after biopsy or inadequate surgery, patients undergo definitive surgery. Patients with complete resection undergo radiotherapy assessment and then randomization. Patients with incomplete or marginal resection (except for central lesions) undergo re-excision and, in the absence of macroscopic disease, assessment for postoperative radiotherapy followed by randomization.\n - Randomization: Patients are randomized to 1 of 2 treatment arms.\n - Arm I: Patients receive no adjuvant chemotherapy or filgrastim (G-CSF). Beginning within 6 weeks after surgery, eligible patients undergo radiotherapy as outlined below.\n - Arm II: Beginning within 4 weeks after surgery, patients receive high-dose doxorubicin IV over 20 minutes followed by ifosfamide IV over 24 hours and G-CSF subcutaneously daily beginning 24 hours after completion of ifosfamide infusion and continuing for 10 days. Treatment continues every 3 weeks for 5 courses. Beginning within 6 weeks after completion of chemotherapy, eligible patients undergo radiotherapy as outlined below.\n - Radiotherapy: Patients with incomplete or marginal resection undergo radiotherapy 5 days a week for 6-6.6 weeks. Patients with complete microscopic resection undergo radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 1 week.\n Patients are followed every 2 months for 1 year, every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter.\n PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 3.5 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically proven soft tissue sarcoma that is amenable to definitive surgery no more than 8 weeks after biopsy or inadequate surgery\n - Eligible subtypes:\n - Alveolar soft part sarcoma\n - Angiosarcoma\n - Fibrosarcoma\n - Leiomyosarcoma\n - Malignant fibrous histiocytoma\n - Liposarcoma (round cell and pleomorphic)\n - Miscellaneous sarcoma (including pelvic mixed mesodermal tumors)\n - Malignant paraganglioma\n - Neurogenic sarcoma\n - Rhabdomyosarcoma\n - Synovial sarcoma\n - Unclassifiable sarcoma\n - Ineligible subtypes:\n - Chondrosarcoma\n - Dermatofibrosarcoma\n - Embryonal rhabdomyosarcoma\n - Ewing's sarcoma\n - Kaposi's sarcoma\n - Liposarcoma (myxoid and well differentiated)\n - Malignant mesothelioma\n - Neuroblastoma\n - Osteosarcoma\n - Confirmed high-grade tumor (i.e., Trojani Grade II or III)\n - No metastases on staging with chest x-ray and thoracic CT scan\n - No regional lymph node involvement\n - Locally recurrent disease allowed\n - Interval of 3 months or more between definitive surgery and recurrence\n PATIENT CHARACTERISTICS:\n Age:\n - 16 to 69\n Performance status:\n - WHO 0-1\n Life expectancy:\n - Not specified\n Hematopoietic:\n - WBC greater than 4,000/mm^3\n - Platelet count greater than 120,000/mm^3\n - No bleeding disorders\n Hepatic:\n - Bilirubin no greater than 1.25 times normal\n - No severe hepatic dysfunction\n Renal:\n - Creatinine less than 1.6 mg/dL OR\n - Creatinine clearance greater than 60 mL/min\n Cardiovascular:\n - No clear history of angina\n - No documented myocardial infarction\n - No existing cardiac failure\n Other:\n - No serious infection\n - No other malignancy except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - Not specified\n Chemotherapy:\n - No prior systemic chemotherapy\n Endocrine therapy:\n - Not specified\n Radiotherapy:\n - No prior radiotherapy to affected area\n Surgery:\n - See Disease Characteristics\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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5
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nSurgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether surgery plus combination chemotherapy is more effective than surgery alone in treating patients with lung metastases from soft tissue sarcoma.\n PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus combination chemotherapy with that of surgery alone in treating patients who have soft tissue sarcoma that has spread to the lung.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Compare disease control, overall survival, and relapse-free survival in patients with lung metastases secondary to soft tissue sarcoma treated with high-dose doxorubicin and ifosfamide with or without filgrastim (G-CSF) before and after metastasectomy vs metastasectomy alone. II. Determine the safety and morbidity of this regimen in these patients.\n OUTLINE: This is a randomized, multicenter study. Patients are stratified according to location of metastases (unilateral vs bilateral). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients are assigned to regimen A or B. Regimen A: Patients receive high-dose doxorubicin IV and ifosfamide IV continuously on day 1 and filgrastim (G-CSF) subcutaneously on days 3-13. Regimen B: Patients receive chemotherapy as above without G-CSF. Treatment on both regimens continues every 3 weeks for 3 courses. Patients then undergo radical pulmonary metastasectomy via thoracotomy or sternotomy with wedge resection or lobectomy. Patients with responding disease after metastasectomy receive 2 additional courses on the regimen to which they were originally assigned. Arm II: Patients undergo radical pulmonary metastasectomy as in arm I. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.\n PROJECTED ACCRUAL: A total of 340 patients (170 per treatment arm) will be accrued for this study within approximately 4.5 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically proven soft tissue sarcoma with pulmonary metastases for which radical metastasectomy is feasible Eligible subtypes: Malignant fibrous histiocytoma Liposarcoma Synovial sarcoma Malignant paraganglioma Fibrosarcoma Leiomyosarcoma Neurogenic sarcoma Unclassified sarcoma Angiosarcoma (including hemangiopericytoma) Miscellaneous sarcoma (including mixed mesodermal tumors of the uterus) Ineligible subtypes: Alveolar rhabdomyosarcoma Kaposi's sarcoma Rhabdomyosarcoma of any type Malignant mesothelioma Chondrosarcoma Neuroblastoma Dermatofibrosarcoma Osteosarcoma Epithelioid sarcoma Primitive neuroectodermal tumor Ewing's sarcoma No extrapulmonary disease Previously treated local recurrence allowed Patients with primarily metastatic disease must have undergone radical treatment of primary tumor according to local protocols Reevaluation of metastases required before randomization\n PATIENT CHARACTERISTICS: Age: 16 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 120,000/mm3 Hepatic: Bilirubin no greater than 1.25 times normal Renal: Creatinine no greater than 1.6 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of cardiovascular disease Other: No other severe medical illness (including psychosis) No prior or concurrent other primary malignancy except adequately treated carcinoma in situ of the cervix or basal cell carcinoma\n PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease Prior neoadjuvant or adjuvant chemotherapy for primary soft tissue sarcoma allowed if cumulative dose of doxorubicin no greater than 200 mg/m2 At least 1 year since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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6
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nCombination Chemotherapy, Surgery, and Radiation Therapy in Treating Children With Advanced Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.\n PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, surgery, and radiation therapy in treating children who have advanced soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Assess the response to vincristine/ifosfamide/doxorubicin (VID) with granulocyte colony-stimulating factor support in children with newly diagnosed, inoperable or metastatic non-rhabdomyosarcoma soft tissue sarcomas. II. Estimate the 2-year and event-free survival rates in children treated with VID plus radiotherapy and/or surgery. III. Establish a bank of frozen tumor and peripheral blood tissue for use in further molecular studies.\n OUTLINE: The following acronyms are used: DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629 IFF Ifosfamide, NSC-109724 Mesna Mercaptoethane sulfonate, NSC-113891 VCR Vincristine, NSC-67574 VID VCR/IFF/DOX Induction: 3-Drug Combination Chemotherapy. VID. Local Control: Surgery and/or Radiotherapy plus 3-Drug Combination Chemotherapy. Excision of the primary tumor and pulmonary metastases; and/or irradiation of the primary tumor and pulmonary metastases using x-rays or Co60 beam energies of at least 4 MV (electrons or iridium-192 implant allowed for boost); plus VID. Continuation: 3-Drug Combination Chemotherapy. VID.\n PROJECTED ACCRUAL: A total of 40 patients will be entered over 2.7 years if there are at least 7 responses in the first 20 patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Biopsy proven non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) Evaluable residual tumor after initial biopsy or excision required Registration required within 42 days of definitive diagnosis Grade II/III, unresectable or metastatic disease The following histologies exclude: Angiofibroma of the nasopharynx Mesothelioma Desmoid tumor Peripheral neuroepithelioma Desmoplastic small cell tumor Rhabdomyosarcoma Extraosseous Ewing's sarcoma Undifferentiated sarcoma Kaposi's sarcoma Grade 1 NRSTS, including: Angiomatoid malignant fibrous histiocytoma Dermatofibrosarcoma protuberans Myxoid and well-differentiated liposarcoma Well-differentiated and infantile hemangiopericytoma Well-differentiated malignant peripheral nerve sheath tumor\n PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine normal for age No hydronephrosis Cardiovascular: Shortening fraction greater than 28% Other: No HIV infection Not pregnant or nursing Effective contraception required of fertile women\n PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy No prior nephrectomy (surgical correction of hydronephrosis allowed)\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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7
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nCombination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug is a way to kill more tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.\n PURPOSE: Randomized phase III trial to compare the effect of two combination chemotherapy regimens followed by radiation therapy in treating patients with small cell lung cancer.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Compare the survival rate in patients with newly diagnosed small cell lung cancer and good performance status treated with an intensive regimen of ifosfamide/carboplatin/etoposide with mid-cycle vincristine (VICE) vs. standard chemotherapy followed, as feasible, by thoracic radiotherapy.\n - Compare the adverse effects of treatment and quality of life (including psychological distress, physical status, and functional status and global quality of life) in these patients.\n - Compare the Rotterdam Symptom Checklist vs. the EORTC QLQ-C30 and LC13 quality-of-life questionnaires in relation to compliance and ability to detect differences between treatments.\n OUTLINE: This is a randomized study.\n The first group receives standard combination chemotherapy with doxorubicin/cyclophosphamide/etoposide (ACE) or cisplatin/etoposide (PE) every 3 weeks for 6 courses.\n The second group receives intensive combination chemotherapy with carboplatin/ifosfamide/etoposide on days 1-3 with vincristine on day 14 (VICE). Courses repeat every 4 weeks for 6 courses.\n Patients in both groups are considered for thoracic radiotherapy beginning 4-5 weeks after the first day of the last course of chemotherapy.\n Concurrent prophylactic antibiotics should be given. Patients who relapse may receive further treatment at the clinician's option.\n Patients are followed monthly for 6 months, every 2 months for up to 1 year, every 3 months for up to 2 years, every 6 months for 5 years, and annually thereafter.\n PROJECTED ACCRUAL: A total of 400 patients will be entered over 3 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Microscopically proven small cell lung cancer\n - Diagnosis based on bronchial, mediastinal, pleural, lung, or lymph node biopsy, sputum cytology, or bronchial brushing or fine needle aspirate cytology\n - No pleural fluid cytology\n - No prior therapy\n PATIENT CHARACTERISTICS:\n Age:\n - Any age\n Performance status:\n - WHO 0-2\n Hematopoietic:\n - WBC more than 3,000\n - ANC more than 1,500\n - Platelets more than 100,000\n Hepatic/Renal:\n - Alkaline phosphatase, aminotransferase, sodium, and LDH normal or no more than 1 of them abnormal\n - Creatinine or urea normal\n - Creatinine clearance or GFR more than 65 mL/min\n Other:\n - No clinical evidence of infection\n - No prior or concurrent malignancy that interferes with protocol treatments or comparisons\n - No other condition that contraindicates treatment\n - Willing and able to complete quality-of-life questionnaires\n - Hospital Anxiety and Depression Scale, Rotterdam Symptom Checklist, and EORTC questionnaires completed prior to randomization\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - See Disease Characteristics\n Chemotherapy:\n - See Disease Characteristics\n Endocrine therapy:\n - See Disease Characteristics\n Radiotherapy:\n - See Disease Characteristics\n Surgery:\n - See Disease Characteristics\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nCryosurgery in Treating Patients With Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Cryosurgery kills cancer cells by freezing them. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining cryosurgery with chemotherapy may kill more tumor cells.\n PURPOSE: Phase I trial to study the effectiveness of cryosurgery with or without chemotherapy in treating patients who have soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Assess the safety and morbidity associated with cryosurgical ablation in patients with soft tissue sarcomas of the extremity.\n OUTLINE: All patients undergo 1 session of cryoablation. Patients with high-grade sarcoma receive systemic chemotherapy 10-14 days after cryoablation at the discretion of the consulting medical oncologist, and undergo surgery 2-3 weeks following chemotherapy. Patients with low-grade sarcoma and those with high-grade sarcoma who do not receive chemotherapy undergo surgery 4-6 weeks after cryoablation. Surgery for all patients consists of en bloc resection or amputation, with limb salvage attempted when feasible. Patients are followed weekly for 3 weeks.\n PROJECTED ACCRUAL: A total of 12 patients (approximately 6 patients with low-grade, high-risk sarcoma and 6 with high-grade sarcoma) will be entered over approximately 6 months. The study will be suspended for the following: vascular complication that requires surgical intervention for correction in 2 patients; any neuropraxia that shows no evidence of resolution after 3 months in 2 patients; any wound complication that requires surgical correction in 4 patients; or any deep wound infection that requires surgical drainage in 4 patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Biopsy-proven soft tissue sarcoma (STS) of the extremity Review by Pathology Department of the University of Southern California CT or MRI required prior to biopsy Disease in one of the following categories: High-grade tumor Low-grade tumor at high risk for local recurrence, i.e.: Adjacent to bone or vital neurovascular structures and able to be removed with a minimal surgical margin (i.e., plane of dissection goes through reactive zone of tumor) Lesion more than 5 cm in diameter The following tumors exclude: Primary sarcoma of the bone Metastatic carcinoma STS of the head and neck Visceral STS, e.g., breast, uterus, spermatic cord, mediastinum chest wall STS of the pelvis or retroperitoneum\n PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Hematopoietic: WBC at least 3,000 Platelets at least 75,000 Hemoglobin at least 9 g/Dl Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 2.5 times normal Renal: Not specified Other: No concurrent disease that renders patient medically or psychologically unable to tolerate treatment\n PRIOR CONCURRENT THERAPY: At least 30 days since therapy for sarcoma\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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9
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nSurgery Followed by Chemotherapy in Treating Young Patients With Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with surgery and/or radiation therapy may kill more tumor cells.\n PURPOSE: This randomized phase III trial is studying surgery followed by different regimens of combination chemotherapy given together with radiation therapy and/or additional surgery to compare how well they work in treating patients with soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Assess whether good survival rates can be maintained for patients with stage I (pathologic T1) soft tissue sarcomas (STS) treated with limited chemotherapy after complete surgical resection, and whether disease-free survival can be improved by improving the precision of pretreatment staging and the assessment of the completeness of the resection.\n - Compare the survival of patients with high-risk nonmetastatic STS treated with alternating regimens of carboplatin, epirubicin, and vincristine (CEV) and ifosfamide, vincristine, and etoposide (IVE) vs continuation of ifosfamide, vincristine, and dactinomycin (IVA) after initial therapy with IVA.\n - Assess whether the improved outcome seen for patients with stage III (node positive) STS in an earlier protocol (SIOP-MMT-89) can be maintained with 3 courses of alternating CEV/IVE without altering local therapy.\n - Compare outcome of patients with nonmetastatic STS to those with stage IV STS who are registered on this protocol but referred to treatment on the European Intergroup Stage IV Study.\n - Assess survival and the risk of late sequelae in patients with non-rhabdomyosarcoma malignant mesenchymal tumors treated on this protocol.\n - Evaluate the role of neoadjuvant chemotherapy, new prognostic factors (e.g., ploidy, histologic grading), and recommendations for the management of fibrosarcoma in infants and of fibromatoses.\n - Assess ifosfamide nephrotoxicity based on total dose administered and the long-term toxicity based on the potential predictive value of early evidence of nephrotoxicity.\n OUTLINE: This is a randomized study for patients with high-risk, nonmetastatic sarcoma, except those with the following characteristics: age less than 6 months, stage I/II non-alveolar orbital tumor, stage III disease, or age less than 3 years with parameningeal disease. Patients are stratified according to disease type (rhabdomyosarcoma (RMS) vs non-RMS disease), parameningeal site of disease, and participating center. Patients with RMS are further randomized by alveolar histology. Randomization occurs after the first course of chemotherapy.\n All patients, regardless of disease stage, are registered to this study and outcome is followed, although patients with metastatic RMS or non-RMS malignant mesenchymal tumors are referred for treatment on the SIOP-MMT-98 study. Patients diagnosed more than 8 weeks prior to entry or who are unavailable for follow-up are not treated on study. Doses are modified for patients under 1 year of age or under 10 kg of body weight. All other patients are assigned therapy based on risk group.\n After surgery, patients with complete resection and with proven or possible chemosensitive histologies proceed to chemotherapy on the low-risk regimen. Patients with questionable completeness of resection proceed to chemotherapy for standard-risk or high-risk tumors, as appropriate. Regardless of resection results, patients who underwent scrotal surgery for paratesticular tumors proceed to chemotherapy for standard-risk tumors. Alveolar RMS is considered high risk.\n LOW-RISK TUMORS (T1 N0 M0): Strategy 951\n - Tumors must be resectable without extensive, mutilating surgery, and resection margins must be microscopically negative at all sites. Patients with positive margins may undergo re-excision.\n - Vincristine is administered weekly for 4 weeks with dactinomycin given on the same day as the first and fourth doses of vincristine. The course is repeated once after a 3-week rest.\n STANDARD-RISK TUMORS (T1-2 N0 M0): Strategy 952\n - After resection as above, patients with incompletely resected T1 tumors, completely resected T1 tumors that extended beyond the tissue or organ of origin, or completely or incompletely resected T2 tumors at favorable sites (vagina, uterus, or paratesticular region) receive chemotherapy on this regimen.\n - Ifosfamide, vincristine, and dactinomycin (IVA) is started within 8 weeks of surgery and administered every 3 weeks for 3 courses; during this course only, vincristine is administered weekly throughout the 6 weeks. Response is assessed at week 8.\n - Patients with at least a 50% response at week 8 receive 3 more courses of IVA and are reassessed at week 17; those with a complete response (CR) discontinue treatment, while those with less than a CR begin local therapy (described below) on week 18 concurrently with 3 more courses of IVA (unless no further response was seen after week 8).\n - Patients with less than a 50% response at week 8 receive carboplatin, epirubicin, and vincristine (CEV) on weeks 9, 15, and 21 and ifosfamide, vincristine, and etoposide (IVE) on weeks 12, 18, and 24. Patients with less than a CR at week 17 receive concurrent local therapy beginning at week 18.\n HIGH-RISK TUMORS: Strategy 953\n - Patients with high-risk tumors after surgery are randomized to IVA as in strategy 952 (Arm I) or to 3 weeks of IVA (1 course) as in Strategy 952 followed by CEV and IVE as in Strategy 952 (Arm II). Response is assessed at week 8. Patients with parameningeal disease who are at least 3 years of age proceed to radiotherapy at week 9, regardless of response.\n - Patients on Arm I with at least a 50% response at week 8 receive 3 more courses of IVA and are reassessed at week 17; those who continue to respond between weeks 8 and 17 receive 3 additional courses of IVA. Patients with no further response receive 4 alternating courses of CEV and IVE. All patients with less than a CR at week 17 begin local therapy on week 18 concurrently with the additional chemotherapy. Patients on Arm I with less than a 50% response at week 8 receive alternating CEV and IVE as in Strategy 952. Patients with less than a CR at week 17 begin concurrent local therapy at week 18.\n - Patients on Arm II who have at least a 50% response at week 8 continue treatment with 2 courses of sequential IVA, CEV, and IVE. Local therapy is concurrently administered, beginning on week 18, to patients who have not achieved a CR by week 17. Patients on Arm II who have less than a 50% response at week 8 proceed immediately to local therapy with additional chemotherapy at the investigator's discretion. Patients with less than a CR after local therapy are considered for treatment on a phase II protocol.\n LOCAL THERAPY\n - Local therapy consists of conservative resection of residual disease (unless more debilitating surgery is appropriate). Patients with residual disease after surgery undergo external-beam radiotherapy 5 days per week for 6-7 weeks or brachytherapy; hyperfractionation is specifically excluded. For patients receiving radiotherapy, the dactinomycin dose in the IVA regimen is omitted from the middle course of chemotherapy and possibly the last course of chemotherapy during concurrent administration. Patients receiving alternating CEV and IVE have the courses reversed during concurrent radiotherapy, with possible omission of epirubicin for the third course.\n - Radical surgery is considered for any patient who has residual disease at week 27.\n TREATMENT FOR RELAPSE\n - Patients treated with Strategy 951 proceed to therapy with at least 6 alternating courses of IVE and CEV, with local therapy initiated after the second course. Other patients receive at least 6 alternating courses of CEV and vincristine, carboplatin, and etoposide (modified Vincaepi), with local therapy initiated after the second course. Patients who have already received either regimen may be re-treated with carboplatin and etoposide and vincristine and cyclophosphamide if relapse occurs more than 6 months after treatment, while those who relapse in less than 6 months are considered for phase II chemotherapy trials. Patients with metastatic relapse are evaluated for bone marrow or peripheral blood stem cell transplantation.\n Patients are followed every 2 months until 2 years after diagnosis, every 3 months for 1 year, every 6 months for 2 years, and then annually until 10 years after diagnosis.\n PROJECTED ACCRUAL: A total of 400 patients with high-risk nonmetastatic disease will be accrued for this study within approximately 4 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically confirmed primary soft tissue sarcoma:\n - Rhabdomyosarcoma\n - Non-rhabdomyosarcoma\n - Soft tissue primitive neuroectodermal tumor (PNET)\n - Extraosseous Ewing's sarcoma\n PATIENT CHARACTERISTICS:\n Age:\n - Under 18\n Performance status:\n - Not specified\n Life expectancy:\n - Not specified\n Hematopoietic:\n - Not specified\n Hepatic:\n - Not specified\n Renal:\n - Not specified\n PRIOR CONCURRENT THERAPY:\n Biologic:\n - Not specified\n Chemotherapy:\n - Not specified\n Endocrine:\n - Not specified\n Radiotherapy:\n - Not specified\n Surgery:\n - Prior primary surgery allowed\n Other:\n - No other prior therapy\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nMonoclonal Antibody A1G4 Plus BCG in Treating Patients With Cancer\n\n**Clinical Trial Summary:**\n\nRATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody A1G4 with BCG may kill more tumor cells.\n PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody A1G4 plus BCG in treating patients with cancer.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Assess the toxicity and feasibility of immunizing patients with anti-idiotypic rat monoclonal antibody A1G4 combined with Bacillus Calmette Guerin (BCG) adjuvant.\n - Determine whether immunization with A1G4 combined with BCG results in an immune response directed against GD2 ganglioside in patients.\n OUTLINE: All patients are treated with A1G4 diluted in sterile physiologic saline mixed with Bacillus Calmette Guerin (BCG) organisms. The vaccine is injected intradermally in multiple sites. Booster immunizations are administered during weeks 2, 4, 8, 12, 20, 28, 36, 44, 52. Immunizations are not administered in limbs where draining lymph nodes have been surgically removed or previously irradiated. Isoniazid is administered for 5 days after each BCG injection. If severe skin reactions are present at the injection site, the BCG dose is decreased. If skin reactions persist, the BCG dose is stopped but A1G4 injections continue.\n At least 6 patients are accrued at each dose level of A1G4. Dose escalation is not carried out until patients have been followed for at least 8 weeks after the first immunization without encountering grade 3 or worse non-skin toxicity.\n If 0-1 patient experiences dose limiting toxicity (DLT) at a given dose level, then patients are accrued to the next higher dose level. If 2 or more patients experience DLT, the MTD is defined as the previous dose level.\n Patients are followed for at least 1 year.\n PROJECTED ACCRUAL: A total of 24 patients are expected to complete this study. If patients are removed early from the study prior to evaluation for serological response, additional patients will be accrued until 6 patients are evaluable for serological response.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically confirmed GD2 positive tumors which include:\n - High risk neuroblastoma (stage IV, or N-myc amplified, or localized neuroblastoma multiply recurrent)\n - Recurrent or metastatic osteosarcoma\n - Recurrent or metastatic GD2 positive sarcomas\n - If free of disease, patient must be fully recovered from toxic effects or complications of prior treatments (chemotherapy or surgery)\n - No greater than 6 months since last chemotherapy or surgery before first injection of A1G4\n PATIENT CHARACTERISTICS:\n Age:\n - Any age\n Performance status:\n - Not specified\n Life expectancy:\n - At least 6 months\n Hematopoietic:\n - Absolute neutrophil count greater than 500/mm^3\n - Absolute leukocyte count greater than 500/mm^3\n - Peripheral T-cell phytohemagglutinin activation (PHA) at least 50% of normal\n Hepatic:\n - Not specified\n Renal:\n - Not specified\n Cardiovascular:\n - No significant heart disease (NYHA class III or IV)\n Other:\n - No other serious intercurrent illnesses\n - No active infections requiring antibiotics\n - No active bleeding\n - No primary immunodeficiency\n - Not pregnant or nursing\n - Adequate contraception required of all fertile patients\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - No concurrent antibiotics\n - No prior mouse antibodies and detectable human antimouse antibody (HAMA) titer\n Chemotherapy:\n - See Disease Characteristics\n - At least 6 weeks since nitrosoureas\n - At least 4 weeks since other systemic chemotherapy\n Endocrine therapy:\n - No concurrent nonsteroidal anti-inflammatory agents\n - No concurrent corticosteroid\n Radiotherapy:\n - At least 4 weeks since radiotherapy\n - No prior radiation therapy to the spleen\n Surgery:\n - See Disease Characteristics\n - No splenectomy\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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11
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nCombination Chemotherapy With or Without Hyperthermia Therapy in Treating Patients With Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. It is not known whether receiving chemotherapy plus hyperthermia is more effective than receiving chemotherapy alone in treating patients with soft tissue sarcoma.\n PURPOSE: This randomized phase III trial is studying combination chemotherapy alone to see how well it works compared to combination chemotherapy and hyperthermia therapy in treating patients with soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine local progression-free survival of patients with high-risk soft tissue sarcoma treated with neoadjuvant etoposide, ifosfamide, and doxorubicin with or without regional hyperthermia.\n - Determine the tumor response rate, local disease control rate, and overall survival in patients treated with this regimen.\n OUTLINE: This is a randomized study. Patients are stratified according to high-risk category (S1 vs S2 vs S3) and disease site (extremity vs nonextremity). Patients are randomized to one of two treatment arms.\n - Arm I: Patients receive etoposide IV over 30 minutes on days 1 and 4, ifosfamide IV over 60 minutes on days 1-4, and doxorubicin IV over 30 minutes on day 1. Treatment continues every 21 days for a total of 4 courses. Patients also undergo regional hyperthermia.\n - Arm II: Patients receive chemotherapy alone as in arm I. Patients in both arms undergo definitive surgery 4-6 weeks after chemotherapy. Patients also undergo radiotherapy beginning 4-6 weeks after surgery. After completion of surgery and radiotherapy, patients with non-resectable tumors showing no disease progression receive an additional 4 courses of chemotherapy with or without regional hyperthermia according to above treatment schedule.\n Patients are followed every 3 months for 1 year, every 4 months for 2 years, and then every 6 months thereafter.\n PROJECTED ACCRUAL: A total of 340 patients (170 patients per arm) will be accrued for this study within 3.5 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically proven grade II or III soft tissue sarcoma of one of following high-risk groups:\n - Grade II/III primary tumor with lesion size of at least 5 cm, deep, and extracompartmental (S1)\n - Local recurrence of primary tumor (S2)\n - Inadequate surgical excision of S1 or S2 (S3)\n - Disease recurrence after prior surgery allowed\n - The following histological types are eligible:\n - Malignant fibrous histiocytoma\n - Liposarcoma (round cell and pleomorphic)\n - Leiomyosarcoma\n - Fibrosarcoma\n - Rhabdomyosarcoma\n - Synovial sarcoma\n - Malignant paraganglioma\n - Neurofibrosarcoma (malignant schwannoma)\n - Extraskeletal Ewing's sarcoma\n - Extraskeletal osteosarcoma\n - Malignant peripheral neuroectodermal tumors\n - Mesenchymal chondrosarcoma\n - Angiosarcoma\n - Miscellaneous sarcoma\n - Unclassified sarcoma\n - No distant metastases\n PATIENT CHARACTERISTICS:\n Age:\n - 18 to 70\n Performance status:\n - WHO 0-2 OR\n - Karnofsky 60-100%\n Life expectancy:\n - Not specified\n Hematopoietic:\n - WBC at least 3,500/mm^3\n - Platelet count at least 100,000/mm^3\n - No bleeding disorder\n Hepatic:\n - Bilirubin less than 1.25 times upper limit of normal\n - No severe hepatic dysfunction\n Renal:\n - Creatinine clearance greater than 60 mL/min\n - No chronic renal failure\n Cardiovascular:\n - No documented existing cardiac failure\n - No manifest heart failure (New York Heart Association class III or IV)\n - Left ventricular ejection fraction no more than 10% below institutional normal\n Other:\n - No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix\n - No other severe disease\n - No severe cerebrovascular disease\n - No extremely obese patients\n - No prior metallic implants relevant to the regional hyperthermia field\n - Not pregnant or nursing\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - Not specified\n Chemotherapy:\n - No prior chemotherapy\n Endocrine therapy:\n - Not specified\n Radiotherapy:\n - No prior radiotherapy (except to disease recurrence outside study irradiation field)\n Surgery:\n - See Disease Characteristics\n - No prior mutilative surgery\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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12
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{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nTroglitazone in Treating Patients With Liposarcoma\n\n**Clinical Trial Summary:**\n\nTroglitazone may help liposarcoma cells develop into normal cells. This was a single arm, open-label study with a two-stage design to evaluate troglitazone in patients with liposarcoma stratified by histologic subtype.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n I. To evaluate the clinical activity of troglitazone in patients with malignant liposarcoma stratified by histologic subtype.\n II. To perform correlative imaging, biological, and biochemical testing of patients in order to define the degree to which in vivo terminal differentiation may be promoted by this therapeutic intervention.\n III. To evaluate the tolerance and safety of troglitazone in this patient population.\n PROJECTED ACCRUAL:\n Initially, 14 patients of each of the 5 histologic subtypes of liposarcoma will be accrued. If 1 or more patients show evidence of biological response, an additional 16 patients of each subtype will be accrued for a total of 30 patients per subtype. If 4 or more of 30 patients achieve biological response then troglitazone will be deemed promising in that histologic subtype.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically proven liposarcoma that is incurable by standard surgery Measurable or evaluable disease required No active CNS involvement or leptomeningeal disease\n PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT less than 5 times upper normal limit Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No poorly controlled atrial arrhythmias, angina pectoris, or myocardial infarction within past 6 months No symptomatic congestive heart failure, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within past 3 months Other: Not pregnant or nursing Fertile patients must use effective contraception No known active retroviral disease\n PRIOR CONCURRENT THERAPY: Recovered from toxic effects of all prior therapy No concurrent cytotoxic therapy Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed Endocrine therapy: No concurrent hormonal therapy Radiotherapy: Prior radiation therapy for metastatic disease allowed No radiotherapy to sole site of measurable disease within past 6 months Surgery: Not specified\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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13
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nIfosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether ifosfamide or doxorubicin is more effective for advanced or metastatic soft tissue sarcoma.\n PURPOSE: Randomized phase III trial to compare the effectiveness of ifosfamide with that of doxorubicin in treating patients who have advanced or metastatic soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the progression free survival rate in patients with advanced or metastatic soft tissue sarcoma treated with either of two different regimens of ifosfamide or doxorubicin. II. Assess the toxic effects of these therapies and response rate in these patients.\n OUTLINE: This is a randomized, multicenter study. Patients are randomized into one of 3 arms (continuous ifosfamide, ifosfamide daily for 3 days, or doxorubicin). Patients are stratified by performance status (0 vs 1), liver involvement (no vs yes), histological type (leiomyosarcoma vs synovial sarcoma vs other), and histological grade (1 vs 2 vs 3). Arm I: Patients receive doxorubicin by bolus infusion for 5-20 minutes once every 3 weeks. Arm II: Patients receive ifosfamide by intravenous infusion for 4 hours on days 1, 2, and 3 every three weeks. Arm III: Patients receive ifosfamide by intravenous infusion for 72 hours every 3 weeks. Patients are assessed after every 2 courses of therapy. Each course of therapy consists of 3 weeks of treatment. Patients may receive a maximum of 6 courses of therapy in the absence of toxicity and disease progression. Patients are followed every 12 weeks for survival.\n PROJECTED ACCRUAL: A total of 780 patients (260 per treatment arm) will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically proven advanced or metastatic soft tissue sarcoma including the following: Malignant fibrous histiocytoma Liposarcoma Rhabdomyosarcoma Synovial sarcoma Malignant paraganglioma Fibrosarcoma Leiomyosarcoma Angiosarcoma including haemangiopericytoma Neurogenic sarcoma Unclassified sarcoma Mixed mesodermal tumor of the uterus Measurable disease with evidence of progression in prior 6 weeks No symptomatic or known CNS metastases\n PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3000/mm3 Neutrophil count greater than 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater 1.75 mg/dL Albumin at least 25 g/L Renal: Creatinine clearance greater than 70 mL/min Cardiovascular: No history of uncontrolled cardiovascular disease Other: Fertile women must use effective contraception No other severe medical illness including psychosis No prior primary malignant tumor except: Adequately treated carcinoma in situ of the cervix Basal cell carcinoma\n PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No radiotherapy to the sole index lesion Surgery: Not specified\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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14
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nAntineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.\n PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating patients who have soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with incurable soft tissue sarcoma.\n - Describe response, tolerance to, and side effects of this regimen in these patients.\n OUTLINE: This is an open-label study.\n Patients receive gradually escalating doses of antineoplastons A10 and AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached.\n Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.\n Tumors are measured every 2 months for 1 year and then every 3 months for 1 year.\n PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically confirmed soft tissue sarcoma that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy\n - Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan\n PATIENT CHARACTERISTICS:\n Age:\n - 6 months and over\n Performance status:\n - Karnofsky 60-100%\n Life expectancy:\n - At least 2 months\n Hematopoietic:\n - WBC at least 2,000/mm^3\n - Platelet count at least 50,000/mm^3\n Hepatic:\n - No hepatic insufficiency\n - Bilirubin no greater than 2.5 mg/dL\n - SGOT and SGPT no greater than 5 times upper limit of normal\n Renal:\n - No renal insufficiency\n - Creatinine no greater than 2.5 mg/dL\n - No history of renal conditions that contraindicate high dosages of sodium\n Cardiovascular:\n - No uncontrolled hypertension\n - No history of congestive heart failure\n - No history of other cardiovascular conditions that contraindicate high dosages of sodium\n Pulmonary:\n - No serious lung disease, such as chronic obstructive pulmonary disease\n Other:\n - Not pregnant or nursing\n - Fertile patients must use effective contraception during and for 4 weeks after study participation\n - No active infection\n - No nonmalignant systemic disease\n - Not high medical or psychiatric risk\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - At least 4 weeks since immunotherapy\n - No concurrent immunomodulating agents\n Chemotherapy:\n - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)\n Endocrine therapy:\n - Concurrent corticosteroids allowed\n Radiotherapy:\n - At least 8 weeks since prior radiotherapy\n Surgery:\n - Recovered from prior surgery\n Other:\n - Prior cytodifferentiating agents allowed\n - No prior antineoplastons\n - No other concurrent antineoplastic agents\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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15
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nTemozolomide in Treating Patients With Advanced Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.\n PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have advanced soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the efficacy, as measured by the response rate, of temozolomide in patients with unresectable, stage IV, or recurrent soft tissue sarcoma who have failed no more than 2 prior treatment regimens. II. Determine the clinical and laboratory toxicities, as well as patient tolerance, of this regimen in this patient population.\n OUTLINE: Patients are stratified according to ECOG performance status (0-1 vs 2), prior surgery (yes vs no), prior radiotherapy (yes vs no), and prior chemotherapy regimens (0 vs 1 vs 2). Patients receive oral temozolomide every 12 hours for 5 days. Courses repeat every 4 weeks for at least 18 months in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for the first 18 months, every 6 months for the next 18 months, and then annually thereafter until death.\n PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically, cytologically, or clinically confirmed unresectable, stage IV, or recurrent soft tissue sarcoma No Ewing's sarcoma, Kaposi's sarcoma, bone sarcomas, mesotheliomas, or primitive neuroectodermal tumors Bidimensionally measurable disease by x-ray, CT scan or MRI, or physical examination No CNS metastases No more than 2 prior chemotherapy regimens for advanced, recurrent, or metastatic disease\n PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin greater than 10.0 g/dL WBC at least 3,500/mm3 OR Absolute neutrophil count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 1.5 times ULN Alkaline phosphatase less than 2 times ULN Renal: Calcium less than ULN Creatinine or BUN less than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or fully excised and/or treated stage I cancer currently in complete remission No nonmalignant systemic disease rendering patient a poor medical risk No acute infection requiring IV antibiotics HIV negative No AIDS-related illness No frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction)\n PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic response modifier treatment allowed At least 4 weeks since prior immunotherapy At least 4 weeks since prior biologic therapy No concurrent epoetin alfa Chemotherapy: See Disease Characteristics Prior dacarbazine allowed At least 4 weeks since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy for malignancy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to areas of measurable disease unless there is clear progression or there is measurable disease outside the area of prior radiation No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery and recovered Other: No other concurrent investigational drugs\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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16
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nAdjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumors cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy is more effective for early-stage breast cancer.\n PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of adjuvant chemotherapy plus radiation therapy in treating women who have early-stage breast cancer.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Compare the effects of synchronous vs sequential adjuvant chemotherapy and radiotherapy on local recurrence, disease-free and overall survival, and treatment delay in women with early-stage breast cancer.\n - Compare the safety of these regimens, in terms of dose intensity and toxicity, in this patient population.\n - Compare the quality of life and cosmetic outcome in patients treated with these regimens.\n OUTLINE: This is a randomized, multicenter study. Patients are stratified according to clinical oncologist, axillary clearance (yes vs no), radiotherapy boost intent (boost vs no boost), and chemotherapy intent (cyclophosphamide, methotrexate, and fluorouracil [5-FU] vs anthracycline-containing regimen). Patients are randomized to one of two treatment arms.\n Patients receive any chemotherapy regimen that includes cyclophosphamide, methotrexate, and 5-FU. Some regimens may also include epirubicin, doxorubicin, mitoxantrone, and/or mitomycin. Chemotherapy repeats every 3 weeks for 4-8 courses.\n - Arm I (synchronous chemoradiotherapy): Patients receiving synchronous therapy receive any of the above chemotherapy regimens plus daily radiotherapy between courses 2 and 3 OR courses 5 and 6 of chemotherapy. Radiotherapy is administered for 3-5 weeks.\n - Arm II (sequential chemoradiotherapy): Patients receiving sequential therapy receive any of the above chemotherapy regimens followed by daily radiotherapy beginning after completion of all chemotherapy (after course 6 or 8). Radiotherapy is administered for 3-5 weeks.\n Treatment in both arms continues in the absence of disease progression or unacceptable toxicity.\n Quality of life is assessed before chemotherapy, 2-3 weeks after the completion of all treatment, and then at 1, 2, and 5 years.\n Patients are followed annually for 10 years.\n Peer Reviewed and Funded or Endorsed by Cancer Research UK\n PROJECTED ACCRUAL: A total of 2,250 patients (1,125 per treatment arm) will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically confirmed invasive breast cancer\n - Early-stage disease\n - No metastatic disease\n - Complete surgical excision of tumor\n - Planned use of adjuvant chemotherapy and radiotherapy\n - If participating in the cosmetic outcome evaluation portion of the study, must have unilateral disease\n - Hormone receptor status\n - Not specified\n PATIENT CHARACTERISTICS:\n Age:\n - Not specified\n Sex:\n - Female\n Menopausal status:\n - Not specified\n Performance status:\n - Not specified\n Life expectancy:\n - Not specified\n Hematopoietic:\n - Bone marrow function adequate\n Hepatic:\n - Hepatic function adequate\n Renal:\n - Renal function adequate\n Cardiovascular:\n - Cardiac function adequate\n Other:\n - No other prior malignancy except basal cell or squamous cell skin cancer or carcinoma in situ\n - No other medical or social condition that would preclude study compliance\n - Fit to receive both adjuvant chemotherapy and radiotherapy (administered either synchronously or sequentially)\n - Not pregnant or nursing\n - Fertile patients must use effective contraception\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - Not specified\n Chemotherapy:\n - See Disease Characteristics\n - No prior chemotherapy\n - No concurrent epirubicin and doxorubicin as a study combination chemotherapy regimen\n Endocrine therapy:\n - Prior or concurrent hormonal therapy allowed\n - No concurrent tamoxifen if treated with methotrexate, mitomycin, and mitoxantrone as a study combination chemotherapy regimen\n Radiotherapy:\n - See Disease Characteristics\n - No concurrent internal mammary chain irradiation\n - No concurrent orthovoltage irradiation to the whole breast\n Surgery:\n - See Disease Characteristics\n - Recovered from prior surgery\n Other:\n - Concurrent participation in another clinical trial allowed\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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17
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nEcteinascidin 743 in Treating Patients With Advanced Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.\n PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients who have advanced soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the therapeutic activity of ecteinascidin 743 in patients with advanced soft tissue sarcomas. II. Determine the duration of response in these patients. III. Determine the acute side effects in these patients.\n OUTLINE: This is a multicenter study. Patients receive ecteinascidin 743 (ET-743) IV over 24 hours every 3 weeks. Treatment continues for at least 2-6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression and every 12 weeks after disease progression.\n PROJECTED ACCRUAL: Approximately 28-44 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically proven soft tissue sarcoma, including the following cell types: Malignant fibrous histiocytoma Liposarcoma Rhabdomyosarcoma Synovial sarcoma Malignant paraganglioma Fibrosarcoma Leiomyosarcoma Angiosarcoma including hemangiopericytoma Neurogenic sarcoma Unclassified sarcoma Miscellaneous sarcoma including mixed mesodermal tumors of the uterus Cell types NOT allowed: Malignant mesothelioma Chondrosarcoma Neuroblastoma Osteosarcoma Ewing's sarcoma Embryonal rhabdomyosarcoma Measurable lesion with evidence of progression within 6 weeks prior to study (osseous lesions, hepatomegaly, lymphedema, ascites, and pleural lesions are not considered measurable) No symptomatic or known CNS metastases\n PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.75 mg/dL Albumin at least 2.5 g/dL AST and ALT less than 1.5 times upper limit of normal (ULN) (2.5 times ULN if liver metastasis present) Alkaline phosphatase less than 2.5 times ULN No other significant hepatic disease (e.g., active hepatitis, cirrhosis, etc.) Renal: Creatinine no greater than 1.36 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No prior cardiovascular disease Other: No other severe medical illness No psychosis No prior or concurrent second primary malignant tumors, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma Fertile patients must use effective contraception\n PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy No more than 1 prior regimen of combination chemotherapy OR No more than 2 prior single agent regimens No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to sole index lesion No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational drugs\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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18
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nMonoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.\n PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus etoposide in treating patients who have neuroblastoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine the antitumor effects of monoclonal antibody 3F8, etoposide, and isotretinoin using standard imaging methods and tumor marker studies in patients with high-risk neuroblastoma.\n - Assess progression-free survival in these patients after this treatment.\n - Assess the effects of oral etoposide on human anti-mouse antibody and anti-idiotype response in these patients.\n OUTLINE: Patients are stratified according to disease status (evaluable but not measurable vs second or subsequent remission with no measurable or evaluable disease).\n Patients receive monoclonal antibody 3F8 (MOAB 3F8) IV over 1.5 hours once daily on days 1-10 and oral etoposide once daily on days 29-49. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression, human anti-mouse antibody (HAMA) response, or unacceptable toxicity.\n If HAMA fails to develop after completion of 4 courses of MOAB 3F8, patients continue treatment with MOAB 3F8 on days 1-5 every 8 weeks until HAMA reaches greater than 1,000 U/mL or until month 24, whichever occurs first.\n Beginning after completion of 4 courses of etoposide and MOAB 3F8 or if HAMA develops, patients receive oral isotretinoin twice daily for 14 days followed by at least a 14-day rest. Treatment repeats for a total of 6 courses.\n PROJECTED ACCRUAL: A total of 50 patients (25 per stratum) will be accrued for this study within 5 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - High-risk neuroblastoma by:\n - Histopathology OR\n - Bone marrow involvement plus elevated urinary catecholamines\n - Prior tumor progression on standard chemotherapy and poor long-term prognosis as indicated by 1 or more of the following:\n - N-myc amplification in tumor cells\n - Diploid chromosomal content plus lp loss of heterozygosity in tumor cells\n - Distant skeletal metastases\n - Unresectable primary tumor infiltrating across the midline\n - More than 10% tumor cells in bone marrow\n - Less than 30% chance of long-term progression-free survival\n - Evaluable (microscopic marrow metastasis, elevated tumor markers, abnormal bone scan or MIBG or PET scan) but not measurable (CT scan, MRI) disease documented at least 4 weeks after completion of prior systemic therapy\n - No rapidly progressive disease as defined by 1 or more of the following:\n - Serum lactic dehydrogenase greater than 1.5 times upper limit of normal due to tumor\n - An opiate requirement for pain from tumor\n - Greater than 25% increase in tumor by successive imaging studies\n - Life expectancy less than 8 weeks\n - Second or subsequent remission after chemotherapy and/or radiotherapy allowed provided there is less than 30% chance of survival\n - No prior myelodysplastic syndromes or leukemia\n PATIENT CHARACTERISTICS:\n Age:\n - Not specified\n Performance status:\n - Not specified\n Life expectancy:\n - See Disease Characteristics\n - At least 8 weeks\n Hematopoietic:\n - Not specified\n Hepatic:\n - No grade 3 or worse liver toxicity\n Renal:\n - No grade 3 or worse renal toxicity\n - Creatinine clearance at least 60 mL/min\n Cardiovascular:\n - No grade 3 or worse cardiac toxicity\n Pulmonary:\n - No grade 3 or worse pulmonary toxicity\n Other:\n - Not pregnant\n - No grade 3 or worse gastrointestinal toxicity\n - No grade 3 or worse neurologic system toxicity\n - No grade 4 hearing deficit\n - No active life-threatening infection\n - No prior exposure to mouse antibodies and human anti-mouse antibody greater than 1,000 ELISA units/mL\n - No allergy to mouse proteins\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - Not specified\n Chemotherapy:\n - See Disease Characteristics\n Endocrine therapy:\n - Not specified\n Radiotherapy:\n - See Disease Characteristics\n Surgery:\n - See Disease Characteristics\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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19
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{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nRadiation Therapy Plus Doxorubicin in Treating Patients With Resectable Primary or Recurrent Retroperitoneal Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.\n PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus doxorubicin in treating patients who have resectable primary or recurrent peritoneal soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the toxicity and maximum tolerated dose of preoperative external beam radiotherapy when combined with doxorubicin and followed by intraoperative radiotherapy in patients with resectable primary or recurrent soft tissue sarcoma of the retroperitoneum. II. Assess radiologic and pathologic response in patients treated with this preoperative regimen.\n OUTLINE: This is a dose-escalation study of external beam radiotherapy. Patients receive doxorubicin IV bolus followed immediately by doxorubicin IV over 4 days every week for 5 weeks concurrently with external beam radiotherapy 5 days a week for 4 weeks. Patients with stable or responding disease undergo surgical resection of primary tumor and all adjacent gross disease approximately 6 weeks after completion of chemoradiotherapy. Patients receive intraoperative radiotherapy (IORT) to the tumor bed if all gross disease has been resected and if the area of maximal tumor adherence to the retroperitoneum can be encompassed within a single IORT field (maximum 15 cm). Cohorts of 3-6 patients receive escalating doses of external beam radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 30% of patients experience grade 3 or worse dose-limiting toxicity.\n PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically or cytologically proven resectable primary or recurrent soft tissue sarcoma of the retroperitoneum Greatest dimension of the 3-dimensional assessment of tumor size must be 5-35 cm Grade 2 or 3, including dedifferentiated liposarcoma and retroperitoneal recurrences of gastrointestinal leiomyosarcoma\n PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Zubrod 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Renal function normal Creatinine less than 1.6 mg/dL Gastrointestinal: Must maintain adequate oral nutrition (90-100% of estimated need for calories and protein) and be free of nausea and vomiting prior to radiotherapy (feeding tube allowed) Other: Prior malignancy allowed at the discretion of the protocol investigator No other serious uncontrolled medical condition Not pregnant or nursing Fertile patients must use effective contraception\n PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior abdominal radiotherapy Surgery: See Disease Characteristics\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nRosiglitazone in Treating Patients With Liposarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Rosiglitazone may help liposarcoma cells develop into normal fat cells.\n PURPOSE: Phase II trial to study the effectiveness of rosiglitazone in treating patients who have liposarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine the clinical activity of rosiglitazone in patients with liposarcoma.\n - Assess the impact of this regimen on markers of tumor proliferation and differentiation status in these patients using biologic and biochemical testing and correlative imaging.\n - Determine the tolerance and safety of this regimen in these patients.\n OUTLINE: Patients are stratified by histologic subtype (well differentiated vs dedifferentiated vs myxoid/round cell vs pleomorphic).\n Patients receive oral rosiglitazone twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.\n Patients are followed at 1-3 weeks and then every 3 months thereafter.\n PROJECTED ACCRUAL: A total of 56-120 patients (14-30 per stratum) will be accrued for this study within 15 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically proven liposarcoma that is incurable with standard multimodality approaches (e.g., surgery and/or radiotherapy and/or chemotherapy)\n - Well differentiated OR\n - Dedifferentiated OR\n - Myxoid/round cell OR\n - Pleomorphic\n - Measurable disease\n - No clinically unstable brain metastases\n - No progression on prior troglitazone therapy for liposarcoma\n PATIENT CHARACTERISTICS:\n Age:\n - 18 and over\n Performance status:\n - ECOG 0-2\n Life expectancy:\n - At least 3 months\n Hematopoietic:\n - Absolute neutrophil count at least 1,000/mm3\n - Platelet count at least 90,000/mm3\n Hepatic:\n - Bilirubin no greater than 2.0 mg/dL\n - SGOT less than 5 times upper limit of normal\n Renal:\n - Creatinine no greater than 2.4 mg/dL\n Cardiovascular:\n - No poorly controlled atrial arrhythmias, symptomatic angina pectoris, or myocardial infarction within the past 4 months\n - No symptomatic congestive heart failure, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within the past 3 months\n Other:\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective barrier contraception\n - Oral contraceptives are not considered effective contraception\n - No active retroviral disease\n - No condition that would preclude informed consent\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - Not specified\n Chemotherapy:\n - See Disease Characteristics\n - Prior chemotherapy allowed and recovered\n - No concurrent cytotoxic therapy\n Endocrine therapy:\n - No concurrent hormonal therapy\n Radiotherapy:\n - See Disease Characteristics\n - Prior radiotherapy allowed and recovered\n - At least 6 months since prior radiotherapy to the sole site of measurable disease\n - Concurrent localized radiotherapy to a single site of disease allowed if there are other sites of measurable disease\n Surgery:\n - Not specified\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nCombination Chemotherapy in Treating Patients With Metastatic Breast Cancer\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Drugs such as mesna may be effective in preventing some of the side effects of chemotherapy.\n PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of etoposide and ifosfamide given with mesna, and cisplatin in treating patients who have metastatic breast cancer.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin.\n - Determine the tolerability and toxicity of this regimen in these patients.\n OUTLINE: Patients are stratified according to number of prior chemotherapy courses for metastatic disease (0 vs 1).\n Patients receive etoposide IV over 60-90 minutes, cisplatin IV over 30 minutes, and ifosfamide IV over 30 minutes on days 1-3. Mesna is administered IV over 15 minutes 30 minutes prior to and 4 hours after ifosfamide, then orally at 8 hours post infusion. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.\n Patients are followed every 3 months.\n PROJECTED ACCRUAL: At least 36 patients (16 per stratum) will be accrued over 36 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically proven progressive metastatic breast cancer\n - Measurable disease\n - Any lesion measurable in 2 dimensions\n - Hepatic metastases if the sum of the measurements below the costal margin in the midclavicular line and the tip to the xiphoid process is greater than 5 cm during quiet respiration\n - Hepatic defects that are clearly measurable by radionuclide, CAT, or MRI scans\n - Bone metastases are not considered measurable disease\n - Evaluable disease allowed if measurable disease also present\n - No brain metastases, carcinomatous meningitis, or spinal cord compression\n - Hormone receptor status:\n - Not specified\n PATIENT CHARACTERISTICS:\n Age:\n - Not specified\n Menopausal status:\n - Not specified\n Performance status:\n - ECOG 0-2\n Life expectancy:\n - At least 3 months\n Hematopoietic:\n - Hemoglobin at least 10 g/dL\n - WBC at least 4,000/mm3\n - Platelet count at least 100,000/mm3\n Hepatic:\n - Bilirubin no greater than 2.0 mg/dL\n Renal:\n - Creatinine no greater than 1.5 mg/dL\n - No bladder outlet obstruction\n Cardiovascular:\n - No symptomatic cardiovascular disease (e.g., congestive heart disease) or inability to tolerate a fluid load\n Other:\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception\n - No active infection\n - No prior malignancies except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - No greater than 1 prior biologic response modifier treatment for metastatic disease\n Chemotherapy:\n - No greater than 1 prior chemotherapy regimen for metastatic disease allowed\n - Patients who relapsed during or within 6 months after adjuvant chemotherapy are considered to have failed 1 regimen\n - Patients who relapsed more than 6 months after adjuvant chemotherapy are considered to not have had a prior regimen\n - Greater than 4 weeks since prior chemotherapy (greater than 6 weeks for mitomycin or nitrosoureas) and recovered\n - No prior cisplatin, etoposide, or ifosfamide\n Endocrine therapy:\n - Prior medical or surgical hormonal therapy allowed\n Radiotherapy:\n - Prior radiation therapy to areas of measurable disease allowed if indicator lesion increased in size by greater than 25% after treatment\n - Recovered from effects of prior radiotherapy\n Surgery:\n - Recovered from effects of major surgery\n Other:\n - At least 7 days since prior nephrotoxic drugs (e.g., aminoglycosides, diuretics, lithium, intravenous contrast, or nonsteroidal antiinflammatory drugs)\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nSTI571 in Treating Patients With Recurrent or Refractory Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: STI571 may interfere with the growth of cancer cells and may be an effective treatment for soft tissue sarcoma.\n PURPOSE: Phase I/II trial to study the effectiveness of STI571 in treating patients who have recurrent or refractory soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the maximum tolerated dose and associated toxicity of STI571 in patients with refractory or recurrent soft tissue sarcoma. II. Determine the pharmacokinetic profile of this treatment regimen in these patients. III. Determine the objective response and duration of response in these patients with this treatment regimen.\n OUTLINE: This is a dose escalation and dose efficacy, multicenter study. In the dose efficacy portion, patients are stratified according to disease type (gastrointestinal stromal tumor vs all other soft tissue sarcomas). Phase I: Patients receive oral STI571 daily for a maximum of 24 months in the absence of disease progression or unacceptable toxicity. Cohorts of 3-8 patients receive escalating doses of STI571 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6-8 patients experience dose limiting toxicities. The recommended phase II dose is defined as the dose preceding the MTD. Phase II: Patients receive the recommended phase II dose of STI571 as in phase I. Patients are followed every 8 weeks until disease progression, and then every 16 weeks thereafter.\n PROJECTED ACCRUAL: Approximately 47-72 patients (7-32 in phase I and 40 in phase II) will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically confirmed soft tissue sarcoma Malignant fibrous histiocytoma Liposarcoma Rhabdomyosarcoma Synovial sarcoma Malignant paraganglioma Fibrosarcoma Leiomyosarcoma Angiosarcoma Hemangiopericytoma Neurogenic sarcoma Unclassified sarcoma Miscellaneous sarcoma (including mixed mesodermal tumors of the uterus) Gastrointestinal stromal tumor (GIST) (must be c-kit positive) No malignant mesothelioma, chondrosarcoma, neuroblastoma, osteosarcoma, Ewing's sarcoma, or embryonal rhabdomyosarcoma Phase I study and nonGIST phase II study patients: Must have received one prior first line combination chemotherapy regimen or two first line single agent regimens Adjuvant chemotherapy not considered first line, unless disease progression within 6 months of treatment Phase II GIST patients: No more than one prior first line combination chemotherapy regimen or two first line single agent regimens Adjuvant chemotherapy not considered first line, unless disease progression within 6 months of treatment Measurable disease with evidence of progression in past 6 weeks Osseous lesions and pleural effusions not considered measurable No symptomatic or known CNS metastases\n PATIENT CHARACTERISTICS: Age: 15 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.8 mg/dL Albumin at least 25 g/L Renal: Creatinine no greater than 1.4 mg/dL OR Creatinine clearance greater than 65 mL/min Cardiovascular: No history of cardiovascular disease Other: No prior or concurrent second primary malignant tumors except adequately treated carcinoma in situ of the cervix or basal cell carcinoma No other severe illness (including psychosis) Not pregnant Fertile patients must use effective contraception during and for 6 months following study\n PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No other concurrent local or systemic chemotherapy Endocrine therapy: No concurrent systemic corticosteroid therapy Radiotherapy: No prior radiotherapy to sole index lesion Concurrent radiotherapy to any lesion allowed if not the sole target lesion Surgery: Not specified Other: No prior embolization to sole index lesion No other concurrent investigational drug No concurrent warfarin\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nMeasurement and Prediction of Outcomes of Amplification\n\n**Clinical Trial Summary:**\n\nThe long-term goal of this research program is to develop methods to predict both the benefit and the satisfaction that hearing-impaired patients will derive from auditory amplification in daily life. This proposal has three primary objectives: (1) To determine the influence of extra-audiological variables, such as personality attributes and expectations, on the subjective outcomes of hearing aid fittings, (2) To establish a scientific basis for selection, administration, and interpretation of self-report measures of hearing aid fitting outcome, (3) To resolve the long-standing debate about the efficacy of using clinically measured loudness perception data in hearing aid prescriptions.\n\n**Clinical Trial Detailed Description:**\n\nThe long-term goal of this research program is to develop methods where by clinicians can predict both the benefit and the satisfaction that individual hearing-impaired patients will derive from amplification in daily life. The present proposal continues the research directions pursued in several cycles of previous RR&D funding from 1986 to 1996. This proposal has three primary objectives: (1) To determine the influence of extra-audiological variables, such as personality attributes and expectations, on the subjective outcomes of hearing aid fittings, (2) To establish a scientific basis for selection, administration, and interpretation of self-report measures of hearing aid fitting outcome, (3) To resolve the long-standing debate about the efficacy of using clinically measured loudness perception data in hearing aid prescriptions.\n HYPOTHESES:\n 1. Inter-subject differences in personality traits, coping style, and/or expectations account for a significant and substantial amount of the variance in hearing aid fitting outcomes, independent of hearing impairment and fitting strategy.\n 2. Prediction of hearing aid fitting outcomes will be substantially improved if the prediction model includes extra-audiological data as well as data on impairment and hearing aid.\n 3. The post-fitting time course of hearing aid fitting outcome data is different for different outcome variables.\n 4. Self-report hearing aid fitting outcomes are stable after 3 months of hearing aid use.\n 5. Fitting outcomes are optimized for individuals with unpredictable loudness perception when clinically measured loudness data are used in the hearing aid fitting protocol.\n PROCEDURES: Investigations will explore:(1)the determinants and characteristics of subjective outcome variables, and (2) the value of individual loudness data in hearing aid fitting. Subjects will be elderly men and women with bilateral sensorineural hearing loss. The work will be performed at the Memphis VAMC Hearing Aid Research Laboratory.\n Determinants and characteristics of subjective outcome variables. When self-reports are used to evaluate hearing aid fitting outcome, it is assumed that the data primarily reflect the efficacy of the hearing aid and the fitting strategy. There is a lack of information about the extent to which other variables might impact self-report data. We will explore this topic with 120 potential hearing aid wearers, followed from their initial expression of interest in amplification through the entire fitting process and for six months after the fitting. Data describing a range of pre-fitting variables as well as hearing impairment, and hearing aid fitting will be collected in a consortium of six clinical sites (including 5 VA sites) coordinated from the Memphis laboratory. The Memphis research team will complete data collection with each subject by collecting outcome data at three post-fitting intervals.\n\n**Clinical Trial Eligibility Criteria:**\n\nHearing-impaired patients\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nAnalysis of Molecular Markers of Drug Resistance in Tumor Biopsies From Previously Untreated Aggressive Non-Hodgkin's Lymphoma\n\n**Clinical Trial Summary:**\n\nAlthough the cause(s) of clinical drug resistance in non-Hodgkin's lymphomas (NHL) are unknown, in vitro studies suggest that abnormalities of the cell cycle and mechanisms of apoptosis may play an important role. Clinical studies have now shown that p53, bcl-2 and tumor proliferation all have significant effects on clinical drug resistance. To further investigate the role of genes that control the cell cycle and apoptosis, we wish to correlate the expression of multiple molecular targets [including but not restricted to bcl-2, BAX, bcl-6, MIB-1, p53, p21, p27, p16, cyclin D(1), cyclin A, cyclin E, mdm-2, cpp 32, mcl-1, EBER-1, ALK, and a panel of B, T and other cell lineage markers], involving these pathways, with clinical outcome following treatment with combination chemotherapy. All clinical data and tissue samples for this study will come from patients who have been previously enrolled on two protocols for the initial treatment of aggressive lymphomas. No new patients will be enrolled for this study.\n\n**Clinical Trial Detailed Description:**\n\nAlthough the cause(s) of clinical drug resistance in non-Hodgkin's lymphomas (NHL) are unknown, in vitro studies suggest that abnormalities of the cell cycle and mechanisms of apoptosis may play an important role. Clinical studies have now shown that p53, bcl-2 and tumor proliferation all have significant effects on clinical drug resistance. To further investigate the role of genes that control the cell cycle and apoptosis, we wish to correlate the expression of multiple molecular targets using immunohistochemistry and cDNA microarray expression profiling (including but not restricted to bcl-2, BAX, bcl-6, MIB-1, p53, p21, p27, p16, cyclin D1, cyclin A, cyclin E, mdm-2, cpp 32, mcl-1, EBER-1, ALK, and a panel of B, T and other cell lineage markers), involving these pathways, with clinical outcome following treatment with combination chemotherapy. All clinical data and tissue samples for this study will come from patients who have been previously enrolled on two protocols for the initial treatment of aggressive lymphomas. No new patients will be enrolled for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nPrior enrollment on the clinical trial of ProMACE-CytaBOM versus ProMACE-MOPP (81-C-0166) or Short Course ProMACE-CytaBOM (87-C-0180) for the treatment of previously untreated aggressive lymphomas.\n Informed consent for participation in the above clinical trials.\n Adequate biopsy material from initial biopsy and/or biopsies at relapse of disease.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nLiposomal Doxorubicin Plus Ifosfamide in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.\n PURPOSE: Phase I trial to study the effectiveness of combining liposomal doxorubicin with ifosfamide in treating patients who have advanced or metastatic soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine the maximum tolerated dose of ifosfamide in combination with doxorubicin HCl liposome in patients with previously untreated advanced or metastatic soft tissue sarcoma.\n - Determine the objective response in patients treated with this regimen.\n - Determine the dose-limiting toxicity in patients treated with this regimen.\n OUTLINE: This is a multicenter, dose-escalation study of ifosfamide.\n Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and ifosfamide IV over 4 hours on days 1-3 OR on days 1-4 (for patients enrolled on dose level 6). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n Cohorts of 3-6 patients receive escalating doses of ifosfamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.\n Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter.\n PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically confirmed soft tissue sarcoma\n - Advanced and/or metastatic disease\n - Must be of any of the following types:\n - Malignant fibrous histiocytoma\n - Liposarcoma (excluding lipomas and well-differentiated liposarcomas)\n - Rhabdomyosarcoma\n - Synovial sarcoma\n - Malignant paraganglioma\n - Fibrosarcoma\n - Leiomyosarcoma\n - Angiosarcoma\n - Neurogenic sarcoma\n - Sarcoma not otherwise specified\n - Paraffin blocks and slides must be available\n - Measurable disease\n - Osseous lesions and pleural effusions are not considered measurable disease\n - Evidence of progressive disease within the past 6 weeks\n - The following conditions are excluded:\n - Gastrointestinal stromal tumors\n - Malignant mesothelioma\n - Chondrosarcoma\n - Neuroblastoma\n - Osteosarcoma\n - Ewing's sarcoma\n - Embryonal rhabdomyosarcoma\n - No symptomatic or known CNS metastases\n PATIENT CHARACTERISTICS:\n Age:\n - 18 to 70\n Performance status:\n - WHO 0-1\n Life expectancy:\n - Not specified\n Hematopoietic:\n - WBC at least 4,000/mm^3\n - Platelet count at least 100,000/mm^3\n Hepatic:\n - Bilirubin no greater than 1.75 mg/dL\n - Albumin at least 2.5 g/dL\n Renal:\n - Creatinine no greater than 1.4 mg/dL\n - Creatinine clearance at least 65 mL/min\n Cardiovascular:\n - Ejection fraction at least 50% by echocardiogram or isotopic methods\n - No history of cardiovascular disease\n Other:\n - No other prior or concurrent primary malignancies except adequately treated carcinoma in situ of the cervix or basal cell carcinoma\n - No other severe medical illness\n - No psychosis\n - No psychological, familial, sociological, or geographical condition that would preclude study participation\n - Not pregnant\n - Fertile patients must use effective contraception (barrier method for men) during and for 6 months after study participation\n PRIOR CONCURRENT THERAPY:\n Biologic therapy:\n - Not specified\n Chemotherapy:\n - No prior chemotherapy for advanced disease\n - No other concurrent systemic chemotherapy for malignancy\n Endocrine therapy:\n - Not specified\n Radiotherapy:\n - No prior radiotherapy to sole indicator lesion\n - Concurrent radiotherapy allowed except to sole indicator lesion\n Surgery:\n - Not specified\n Other:\n - No other concurrent investigational drugs\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nErlotinib in Treating Patients With Malignant Mesothelioma of the Lung\n\n**Clinical Trial Summary:**\n\nErlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. This phase II trial is studying how well erlotinib works in treating patients with malignant mesothelioma of the lung\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\n I. Determine the 1-year survival rate in patients with unresectable malignant pleural mesothelioma treated with erlotinib.\n II. Determine the response rate in patients with measurable disease treated with this drug.\n III. Determine the frequency and severity of toxic effects of this drug in these patients.\n IV. Measure epidermal growth factor receptor (EGFR) expression, EGFR gene amplification, and other activation products in the EGFR signaling pathway in tumor samples and correlate with clinical outcomes in patients treated with this drug.\n OUTLINE: This is a multicenter study.\n Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n Patients are followed every 6 months for 2 years and then annually for 1 year.\n PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 14-18 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Histologically confirmed malignant pleural mesothelioma\n - Epithelial\n - Sarcomatous\n - Biphasic\n - Measurable or nonmeasurable disease\n - Not amenable to extrapleural pneumonectomy\n - No known CNS metastases\n - Performance status - Zubrod 0-1\n - WBC at least 3,000/mm^3\n - Absolute neutrophil count at least 1,500/mm^3\n - Platelet count at least 100,000/mm^3\n - Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n - SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver involvement of tumor)\n - Creatinine no greater than 2 times ULN\n - No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation\n - No active peptic ulcer disease\n - No intractable nausea or vomiting\n - Must be able to swallow and/or receive enteral medications via gastrostomy feeding tube\n - No known history of the following:\n - Dry eye syndrome\n - Sjogren's syndrome\n - Keratoconjunctivitis sicca\n - Exposure keratopathy\n - Fuch's dystrophy\n - Other active disorders of the cornea\n - Not pregnant or nursing\n - Fertile patients must use effective contraception\n - No HIV-positive patients receiving combination antiretroviral therapy\n - No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer that is in complete remission\n - No prior biologic therapy for this tumor\n - No prior chemotherapy for this tumor\n - See Disease Characteristics\n - At least 3 weeks since prior radiotherapy and recovered\n - See Disease Characteristics\n - At least 4 weeks since prior major surgery (e.g., thoracotomy or laparotomy), excluding minor surgeries (e.g., mediastinoscopy, thoracoscopy, or minor biopsies)\n - Recovered from prior surgery\n - No prior surgical procedures affecting absorption\n - No prior investigational anticancer agents for this tumor\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nErlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme\n\n**Clinical Trial Summary:**\n\nRATIONALE: Erlotinib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.\n PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have recurrent or progressive glioblastoma multiforme.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine the response rate of patients with recurrent or progressive glioblastoma multiforme treated with erlotinib.\n - Determine the progression-free and overall survival of patients treated with this drug.\n OUTLINE: Patients receive oral erlotinib daily. Treatment continues in the absence of disease progression or unacceptable toxicity.\n Patients are followed for survival.\n PROJECTED ACCRUAL: A total of 73 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically confirmed glioblastoma multiforme\n - Radiographic evidence of recurrence or progression\n - Biopsies to confirm tumor recurrence allowed if a sufficent percentage of cases are confirmed to be recurrent tumor\n - Previously treated with optimal radiotherapy and at least 1 cytotoxic chemotherapy regimen\n PATIENT CHARACTERISTICS:\n Age\n - 18 and over\n Performance status\n - Not specified\n Life expectancy\n - Not specified\n Hematopoietic\n - Absolute neutrophil count at least 1,500/mm^3\n - Platelet count at least 100,000/mm^3\n Hepatic\n - Bilirubin no greater than 2 times normal\n - Alkaline phosphatase no greater than 2 times normal\n - ALT no greater than 3 times normal\n Renal\n - BUN no greater than 1.5 times normal OR\n - Creatinine no greater than 1.5 times normal\n Other\n - Not pregnant or nursing\n - Negative pregnancy test\n - Fertile patients must use effective contraception\n - No medical condition that would interfere with oral administration of erlotinib\n - No other medical or psychiatric illness that would preclude study therapy\n - No active infection\n - No other malignancy within the past 3 years except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer\n PRIOR CONCURRENT THERAPY:\n Biologic therapy\n - No concurrent immunotherapy for brain cancer\n - No concurrent biologic therapy for brain cancer\n Chemotherapy\n - See Disease Characteristics\n - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered\n - No concurrent chemotherapy for brain cancer\n Endocrine therapy\n - Concurrent glucocorticosteroids allowed\n - No concurrent hormonal therapy for brain cancer\n Radiotherapy\n - See Disease Characteristics\n Surgery\n - Not specified\n Other\n - No prior epidermal growth factor receptor (EGFR) inhibitor\n - No concurrent EGFR inhibitor\n - No other concurrent antineoplastic therapy\n - No concurrent anti-epileptic agents other than modest- or non-enzyme-inducing drugs such as the following:\n - Gabapentin\n - Lamotrigine\n - Divalproex\n - Felbamate\n - Levetiracetam\n - Tiagabine\n - Topiramate\n - Zonisamide\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.\n\n**Clinical Trial Detailed Description:**\n\nThis is an open-label (patients will know the names of the study drugs they receive), randomized (patients will be assigned by chance to receive 1 of 2 treatment schedules with trabectidin) study designed to examine the the survival, safety, and pharmacokinetics (blood levels) trabectedin when administered to patients with 2 types of cancer (Liposarcoma or Leiomyosarcoma) who have received treatment with other anti-cancer therapy (Anthracycline and/or Ifosfamide). Trabectedin (also referred to as Yondelis) is a drug being developed to treat patients with cancer. Yondelis will be administered intravenously (i.v.) via a central catheter (tube) into a central vein once a week (0.58 mg/m2 as a 3-hour infusion on Days 1, 8, and 15 of each 28-day treatment cycle) or once every 3 weeks (1.5 mg/m2 administered as a 24-hour infusion on Day 1 of every 21-day treatment cycle) until disease progression. Patients in each arm will be pretreated with 20 mg of dexamethasone i.v. 30 minutes prior to each infusion.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Have advanced liposarcoma or leiomyosarcoma that has metastasized (spread)\n - Have a pathology specimen available for centralized review\n - Have progressive or relapsed (reappearance of) disease, received treatment with anthracycline and/or ifosfamide before enrollment in study, and have at least one measurable tumor lesion\n - Have adequate bone marrow, liver and kidney function\n - Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n Exclusion Criteria:\n - Previous exposure to Yondelis i.v. formulation, ET-743 (ecteinascidin)\n - Cancer that has metastasized (spread) to the central nervous system\n - Active viral hepatitis or chronic liver disease\n - Unstable cardiac (heart) condition including congestive heart failure or angina pectoris (heart pain), myocardial infarction (heart attack) within 1 year before enrollment\n - History of another neoplastic (malignant or nonmalignant tumor) disease (except basal cell carcinoma or cervical carcinoma adequately treated), unless in remission for 5 years or more before enrollment\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nDoxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors, such as pegfilgrastim, cause the body to make blood cells. It is not yet known whether doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating soft tissue sarcoma.\n PURPOSE: This randomized phase III trial is studying giving doxorubicin alone to see how well it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in treating patients with locally advanced or metastatic soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Compare the progression-free and overall survival of patients with locally advanced or metastatic soft tissue sarcoma treated with doxorubicin with vs without ifosfamide and pegfilgrastim as first-line therapy.\n - Compare the response in patients treated with these regimens.\n - Compare the treatment-related mortality of patients treated with these regimens.\n - Compare the toxicity of these regimens in these patients.\n OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to WHO performance status (0 vs 1), age group (less than 50 years of age vs 50 years of age and over), presence of liver metastases (yes vs no), histological grade (2 vs 3), and participating center. Patients are randomized to 1 of 2 treatment arms.\n - Arm I: Patients receive doxorubicin IV on day 1 (or IV continuously on days 1-3).\n - Arm II: Patients receive doxorubicin IV on days 1-3 and ifosfamide IV over 4 hours on days 1-4. Patients also receive pegfilgrastim subcutaneously on day 5.\n In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter.\n PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically confirmed soft tissue sarcoma\n - Locally advanced unresectable* OR metastatic disease\n - High-grade (grade 2-3) disease according to the FNLCC grading system NOTE: *Disease that could prove resectable (including pulmonary metastasectomy) after a response to chemotherapy is allowed\n - The following tumor types are eligible:\n - Malignant fibrous histiocytoma\n - Myxoid and round cell liposarcoma, pleomorphic liposarcoma, or dedifferentiated liposarcoma\n - Pleomorphic rhabdomyosarcoma\n - Synovial sarcoma\n - Myxofibrosarcoma, intermediate and high-grade\n - Fibrosarcoma\n - Leiomyosarcoma\n - Angiosarcoma\n - Malignant peripheral nerve sheath tumor\n - Epithelioid sarcoma\n - Alveolar rhabdomyosarcoma\n - Unclassifiable sarcoma, not otherwise specified\n - The following tumor types are not eligible:\n - Gastrointestinal stromal tumor\n - Mixed mesodermal tumor\n - Chondrosarcoma\n - Malignant mesothelioma\n - Neuroblastoma\n - Osteosarcoma\n - Ewing's sarcoma/primitive neuroectodermal tumor\n - Desmoplastic small round cell tumor\n - Embryonal rhabdomyosarcoma\n - Alveolar soft part sarcoma\n - Must have a measurable lesion with clinical evidence of progression within the past 6 weeks\n - Osseous lesions and pleural effusions are not considered measurable\n - No known or symptomatic CNS metastases\n PATIENT CHARACTERISTICS:\n Age\n - 18 to 60\n Performance status\n - WHO 0-1\n Life expectancy\n - Not specified\n Hematopoietic\n - Absolute neutrophil count at least 2,000/mm^3\n - Platelet count at least 100,000/mm^3\n Hepatic\n - Bilirubin no greater than 1.8 mg/dL\n - Albumin at least 2.5 g/dL\n Renal\n - Creatinine no greater than 1.4 mg/dL OR\n - Creatinine clearance greater than 65 mL/min\n Cardiovascular\n - No history of cardiovascular disease\n Other\n - Not pregnant\n - Negative pregnancy test\n - Fertile patients must use effective contraception\n - No other severe medical illness\n - No psychosis\n - No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or basal cell skin cancer\n - No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up schedule\n PRIOR CONCURRENT THERAPY:\n Biologic therapy\n - Not specified\n Chemotherapy\n - No prior chemotherapy for advanced or metastatic disease\n - Prior adjuvant chemotherapy allowed provided there was no disease progression within 6 months after completion of treatment\n Endocrine therapy\n - Not specified\n Radiotherapy\n - No prior radiotherapy to the sole index lesion\n Surgery\n - Not specified\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nVaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor\n\n**Clinical Trial Summary:**\n\nRATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may cause a stronger immune response and kill more tumor cells.\n PURPOSE: This phase I trial is studying the side effects of vaccine therapy when given together with sargramostim in treating patients with advanced sarcoma or brain tumor.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine the feasibility of treatment with telomerase: 540-548 peptide vaccine and sargramostim (GM-CSF) in patients with sarcoma or brain tumor.\n - Determine the safety and tolerability of this regimen in these patients.\n - Determine the frequency of T-cell specific vaccine antigens during and after administration of this regimen in these patients.\n - Determine, preliminarily, the clinical response, if any, of patients treated with this regimen.\n OUTLINE: Patients receive telomerase: 540-548 peptide vaccine subcutaneously (SC) on day 3 and sargramostim (GM-CSF) SC on days 1-4 of weeks 1, 3, 5, 7, 9, 11, 15, 19, and 23.\n PROJECTED ACCRUAL: A total of 35 patients (20 adult and 15 pediatric) will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Histologically or cytologically confirmed diagnosis of 1 of the following malignancies:\n - Stage III or IV sarcoma, including:\n - Leiomyosarcoma\n - Synovial cell sarcoma\n - Liposarcoma\n - Gastrointestinal stromal tumor\n - Brain tumor, including:\n - Diffuse pontine glioma*\n - Glioblastoma multiforme\n - Glialsarcoma NOTE: *For patients with diffuse pontine glioma, the requirement for histologic verification may be waived\n - No known curative therapy\n - HLA A*0201 positive by genotyping\n PATIENT CHARACTERISTICS:\n Age\n - Over 2\n Performance status\n - Karnofsky 60-100% (patients over age 16)\n - Lansky 60-100% (patients under age 16)\n Life expectancy\n - Not specified\n Hematopoietic\n - WBC greater than 3,000/mm^3\n - Absolute neutrophil count greater than 1,500/mm^3\n - Platelet count greater than 100,000/mm^3\n Hepatic\n - AST and ALT less than 2.5 times upper limit of normal (ULN)\n - Bilirubin less than 1.5 times ULN\n Renal\n - Creatinine less than 1.5 times ULN\n Cardiovascular\n - No clinically significant cardiovascular disease\n Pulmonary\n - No clinically significant pulmonary disease\n PRIOR CONCURRENT THERAPY:\n Biologic therapy\n - No prior hematopoietic stem cell transplantation\n - No other concurrent vaccine therapy\n - No other concurrent immunotherapy\n Chemotherapy\n - No prior chemotherapy\n - No concurrent chemotherapy\n Endocrine therapy\n - Concurrent dexamethasone allowed provided patient has been on a decreasing dose for the past 2 weeks and the current dose is the lowest clinically acceptable dose (ideally, less than 9-12 mg/day)\n Radiotherapy\n - No prior extensive-field radiotherapy that would compromise bone marrow function\n - At least 2 weeks since prior local radiotherapy\n Surgery\n - At least 2 weeks since prior surgery\n Other\n - At least 2 weeks since prior imatinib mesylate\n - No concurrent local anesthetic to administration site of vaccine\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nMonoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Monoclonal antibodies, such as monoclonal antibody 3F8, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Combining monoclonal antibody 3F8 with sargramostim may cause a stronger immune response and kill more tumor cells.\n PURPOSE: Phase II trial to study the effectiveness of combining monoclonal antibody 3F8 with sargramostim in treating patients who have neuroblastoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine the efficacy of sargramostim (GM-CSF) in enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk neuroblastoma.\n - Determine the prognostic impact of minimal residual bone marrow disease on relapse-free survival of patients treated with this regimen.\n - Compare the effects of short-term (2-hour intravenous) vs prolonged (subcutaneous release) daily GM-CSF on granulocyte activation, in order to establish the optimal route for tumor-cell kill in these patients.\n OUTLINE: This is an open-label study. Patients are stratified according to evaluable disease (yes [primary refractory bone marrow disease] vs no [no evidence of disease]).\n Patients receive sargramostim (GM-CSF) subcutaneously on days -5 to 4 and monoclonal antibody 3F8 IV over 0.5-1.5 hours on days 0-4. Treatment repeats every 3 weeks for 4 courses and then every 8 weeks for up to a total of 24 months in the absence of disease progression or unacceptable toxicity.\n Beginning after 2 courses of GM-CSF and monoclonal antibody 3F8, patients also receive oral isotretinoin twice daily on days 1-14 (when no monoclonal antibody 3F8 is administered). Treatment with isotretinoin repeats approximately every 28 days for 6 courses.\n PROJECTED ACCRUAL: A total of 340 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Diagnosis of neuroblastoma by histopathology OR bone marrow metastases and high urine catecholamine levels\n - Disease must meet risk-related treatment guidelines and any of the following International Neuroblastoma Staging System stages:\n - Stage 4 with (any age) OR without (> 18 months of age of age) MYCN amplification\n - MYCN-amplified other than stage 1\n - No evidence of disease (i.e., in complete response/remission or very good partial response/remission) OR disease resistant to standard therapy (i.e., incomplete response in bone marrow)\n - No progressive disease or MIBG-avid soft tissue tumor\n PATIENT CHARACTERISTICS:\n - No existing renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity ≥ grade 3\n - No human anti-mouse antibody (HAMA) titer greater than 1,000 Elisa units/mL\n - No history of allergy to mouse proteins\n - No active life-threatening infection\n - Not pregnant\n - Negative pregnancy test\n PRIOR CONCURRENT THERAPY:\n - Not specified\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nGefitinib in Treating Patients With Progressive Metastatic Neuroendocrine Tumors\n\n**Clinical Trial Summary:**\n\nThis phase II trial is studying how well gefitinib works in treating patients with progressive metastatic neuroendocrine tumors. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\n I. To determine the 6 month progression free survival rate in patients with progressive, advanced neuroendocrine tumors treated with ZD1839.\n SECONDARY OBJECTIVES:\n I. Objective tumor response rate. II. Progression free survival and time to progression. III. Improvement in circulating hormone levels. IV. Overall survival V. We will explore the molecular characterization of these tumors in attempt to understand the role of EGFR expression and its inhibition with ZD1839 in neuroendocrine tumors. The measurements will be performed on pretreatment and post-treatment tumor biopsies when possible: EGFR expression and gene amplification (IHC for EGFR and phosphorylated EGFR, ISH for gene amplification); Activation of the Ras/Raf/MAPK pathway (IHC for phosphorylated MAPK); Cell proliferation (Ki-67 staining); Apoptosis (TUNEL assay).\n OUTLINE: This is a multicenter study. Patients are stratified according to disease type (carcinoid vs islet cell and other neuroendocrine tumors).\n Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n Patients are followed every 3 months until disease progression and then every 6 months for up to 2 years from study entry.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Histologically confirmed metastatic neuroendocrine neoplasms or histologic confirmation of primary neuroendocrine tumor with clear clinical evidence of metastases\n - Measurable disease\n - Radiographic evidence of disease progression, following any prior systemic therapy, chemoembolization, embolization, or observation; for eligibility purposes, disease progression will be defined as follows:\n - Either of the following documented by comparison of the on-study radiographic assessment with a prior assessment of the same type performed within the previous 60 calendar weeks:\n - Appearance of a new lesion\n - At least 20% increase in the longest diameter (LD) of any previously documented lesion or an increase in the sum of the LDs of multiple lesions in aggregate of 20%\n - ≥4 weeks from the completion of major surgery, chemotherapy or other systemic therapy and hepatic artery embolization/chemoembolization to study registration\n - ≥3 weeks from the completion of radiation therapy to study registration\n - Recovered sufficiently from side effects of prior therapy\n - Absolute neutrophil count (ANC) ≥ 1000/mm3\n - PLT ≥ 75,000/ mm3\n - Hgb ≥ 8.0 g/dL\n - Total bilirubin ≤ 2 x upper normal limit (UNL)\n - Alkaline phosphatase ≤ 3 x UNL (5 x UNL if liver metastases present)\n - AST ≤ 3 x UNL (≤ 5 x UNL if liver metastases present)\n - Creatinine ≤ 1.5 x UNL\n - ECOG performance score (ps) ≤ 2\n - Life expectancy ≥ 24 weeks\n - Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent\n Exclusion Criteria:\n - Thyroid carcinoma of any histology or pheochromocytoma/paraganglioma\n - Any of the following as this regimen may be harmful to a developing fetus or nursing child:\n - Pregnant women\n - Breastfeeding women\n - Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)\n - NOTE: The effects of the agent(s) on the developing human fetus at the recommended therapeutic dose are unknown\n - Anaplastic or high-grade histology\n - Any of the following prior therapies:\n - > 1 prior systemic chemotherapy regimen (chemoembolization not counted as systemic chemotherapy)\n - Prior EGFR targeted regimen (e.g. OSI-774, EKB-569, ZD1839)\n - < 4 weeks from last Interferon injection\n - < 2 weeks from last octreatide short acting injection or < 6 weeks long acting injection; Note: concurrent octreatide allowed if stable dose has been administered for ≥1 month, there is documented tumor progression on the current dose, and there is no current plan for increasing dose • Other concurrent treatment considered investigational\n - Concurrent chemotherapy or radiation therapy\n - Any of the following:\n - Gastrointestinal tract disease resulting in an inability to take oral medication (e.g. dysphagia or inability to swallow capsules intact).\n - Requirement for IV alimentation\n - Prior procedures clearly adversely affecting intestinal absorption\n - Active peptic ulcer disease\n - Failure to fully recover from adverse effects of prior therapies regardless of interval since last treatment\n - Known abnormality of cornea, such as:\n - History of dry eye syndrome or Sjogren syndrome\n - Congenital abnormality\n - Abnormal slit-lamp examination using a vital dye (e.g.: fluorescein or Bengal-rose)\n - Abnormal corneal sensitivity test (Schirmer test)\n - Uncontrolled intercurrent illness including, but not limited to:\n - Ongoing or active infection\n - Symptoms of congestive heart failure\n - Unstable angina pectoris, cardiac arrhythmia\n - Psychiatric illness/social situation that would limit compliance with study requirement\n - Known brain metastases; Note: These patients are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events\n - Known HIV-positive patients receiving combination anti-retroviral therapy; Note: These patients are excluded from the study because of possible pharmacokinetic interactions with ZD1839 and because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination and anti-retroviral therapy when indicated\n - Concurrent or recent use (≤ 7 days prior to ZD1839 administration) of phenytoin, carbamazepine, barbiturates, rifampicin, oxcarbazepine, rifapentine, modafinil, or St. John's Wort; Note: Because these drugs induce CYP3A4 enzymes and can cause reductions in ZD1839 plasma concentrations below levels thought to be biologically active, patients with concurrent or recent use of these drugs are excluded from the study\n - History of other invasive malignancy ≤ the previous 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nRadiolabeled Monoclonal Antibody Therapy in Treating Patients With Refractory, Recurrent, or Advanced CNS or Leptomeningeal Cancer\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to find a safe dose of a new medicine called antibody 8H9. Antibodies are made by the body to fight infections and in some cases, to fight tumors. The antibody 8H9 is made by mice and can attack many kinds of tumors. 8H9 antibody can have a dose of radiation attached to it called 131-I. 131I-8H9 has been given in the vein to patients to find cancer cells. This is the first study using 131I-8H9 in the fluid in the spine to kill cancer cells. 131-I is a beta emitting isotope used extensively for radiation targeted therapies.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nSubject Inclusion Criteria:\n - Patients must have a histologically confirmed diagnosis of a malignancy known to be 8H9 reactive. 8H9 expression must be confirmed by immunohistochemical staining of tumor and assessed by the Department of Pathology or by immunofluorescence of bone marrow except for patients confirmed to have neuroblastoma.\n - Patients must have CNS/ leptomeningeal disease which is refractory to conventional therapies or for which no conventional therapy exists OR a recurrent brain tumors with a predilection for leptomeningeal dissemination (medulloblastoma, PNET, rhabdoid tumor).\n - Patients must have no rapidly progressing or deteriorating neurologic examination.\n - Patients must have an absolute neutrophil count (ANC) > 1000/ul and a platelet count > 50,000/ul.\n - Patients may have active malignancy outside the central nervous system.\n - Both pediatric and adult patients of any age are eligible.\n - Patients or a legal guardian will sign an informed consent form approved by the IRB and obtained by the Principal or a Co- Investigator before patient entry. Minors will provide assent.\n - Patients with stored stem cells will be treated at the escalating dose while patients with no stem cells will be treated at the 50 mCi dose. Neuroblastoma patients can be treated at the 50 mCi dose with or without stored stem cells.\n Subject Exclusion Criteria:\n - Patients with obstructive or symptomatic communicating hydrocephalus.\n - Patients with an uncontrolled life-threatening infection.\n - Patients who are pregnant: Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is required during the study period.\n - Patients who have received cranial or spinal irradiation less than 3 weeks prior to the start of this protocol.\n - Patients who have received systemic chemotherapy (corticosteroids not included) less than 3 weeks prior to the start of this protocol.\n - Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity should all be less than grade 2. Patients with stable neurological deficits (because of their brain tumor) are not excluded. Patients with <= 3 hearing loss are not excluded.\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nBiological Therapy in Treating Patients With Neuroblastoma That Has Not Responded to Previous Treatment\n\n**Clinical Trial Summary:**\n\nRATIONALE: Monoclonal antibodies, such as monoclonal antibody 3F8, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Beta-glucan, isotretinoin, and sargramostim may increase the effectiveness of monoclonal antibody 3F8 by making tumor cells more sensitive to the monoclonal antibody. Combining different types of biological therapy may kill more tumor cells.\n PURPOSE: This phase II trial is studying how well giving beta-glucan, isotretinoin, and sargramostim together with monoclonal antibody 3F8 works in treating patients with neuroblastoma that has not responded to previous treatment.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\n - Determine the efficacy of beta-glucan, isotretinoin, and sargramostim (GM-CSF) in enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk refractory neuroblastoma.\n - Determine the antitumor activity of this regimen, in terms of assessing disease status in the bone marrow by real-time quantitative reverse transcription polymerase chain reaction, in these patients.\n - Determine the toxicity of this regimen in these patients.\n OUTLINE: This is an open-label study. Patients are stratified according to refractory disease (primary refractory [never had disease progression or disease recurrence] vs secondary refractory [recurrent disease that did not respond completely to reinduction therapy]).\n - Courses 1 and 2: Patients receive sargramostim (GM-CSF) subcutaneously once daily on days -5 to 11. Patients also receive oral beta-glucan once daily on days -2 to 11 and monoclonal antibody (MOAB) 3F8 IV over 30-90 minutes on days 0-4 and 7-11.\n - Courses 3 and 4: Patients receive GM-CSF, beta-glucan, and MOAB 3F8 as above. Patients also receive oral isotretinoin twice daily on days -2 to 11.\n Treatment repeats every 2-4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.\n Patients are followed every 3 months for 2 years.\n PROJECTED ACCRUAL: A total of 27-74 patients (10-33 for stratum 1 and 17-41 for stratum 2) will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\n - Diagnosis of neuroblastoma, as defined by 1 of the following:\n - Histologically confirmed disease\n - Bone marrow metastases plus high urine catecholamines\n - High-risk disease meeting 1 of the following stage criteria:\n - Stage IV, with 1 of the following:\n - Any age with MYCN amplification\n - > 18 months of age without MYCN amplification\n - Stage III, with both of the following:\n - Any age with MYCN amplification\n - Unresectable disease\n - Stage 4S with MYCN amplification\n - Measurable or evaluable soft tissue disease\n - Relapsed disease resistant to standard induction chemotherapy and salvage therapy\n PATIENT CHARACTERISTICS:\n Age\n - Any age\n Performance status\n - Not specified\n Life expectancy\n - Not specified\n Hematopoietic\n - Not specified\n Hepatic\n - No severe hepatic toxicity ≥ grade 3\n Renal\n - No severe renal toxicity ≥ grade 3\n Cardiovascular\n - No severe cardiac toxicity ≥ grade 3\n Pulmonary\n - No severe pulmonary toxicity ≥ grade 3\n Other\n - Not pregnant\n - Negative pregnancy test\n - No severe neurologic toxicity ≥ grade 3\n - No severe gastrointestinal toxicity ≥ grade 3\n - No other severe major organ dysfunction except ototoxicity\n - No history of allergy to mouse proteins\n - No active life-threatening infection\n - No human anti-mouse antibody titer > 1,000 ELISA units/mL\n PRIOR CONCURRENT THERAPY:\n Biologic therapy\n - Not specified\n Chemotherapy\n - See Disease Characteristics\n Endocrine therapy\n - Not specified\n Radiotherapy\n - Not specified\n Surgery\n - Not specified\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35
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"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nStudy of AP23573/MK-8669 (Ridaforolimus), A Mammalian Target of Rapamycin (mTOR) Inhibitor, in Participants With Advanced Sarcoma (MK-8669-018 AM1)(COMPLETED)\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to assess the efficacy of ridaforolimus when administered once daily for 5 consecutive days (QDx5) every two weeks in participants with advanced sarcoma.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Patients ≥15 years of age with metastatic and/or unresectable sarcomas of the following histological subgroups: Bone sarcomas, such as osteosarcoma and Ewings sarcoma; Leiomyosarcoma; Liposarcomas; Any other soft tissue sarcoma except gastrointestinal stromal tumors (GIST). Patients with well-differentiated liposarcoma or desmoid tumors must have demonstrated progressive disease within the previous 6 months\n - Presence of at least one measurable lesion that: Can be accurately measured in at least one dimension with longest diameter ≥20 mm using conventional techniques or ≥10 mm with spiral computerized tomography (CT) scan (or otherwise at least twice the reconstruction interval for CT or magnetic resonance imaging [MRI] scans)\n - Eastern Cooperative Oncology Group (ECOG) performance status ≤1\n - Minimum life expectancy of 3 months\n - Adequate renal and hepatic function, as specified in the protocol\n - Adequate bone marrow function, as specified in the protocol\n - Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL\n - Male and female patients who are not surgically sterile or postmenopausal must agree to use reliable methods of birth control for the duration of the study until 30 days after the last dose of study drug\n - Able to understand and give written informed consent\n Exclusion Criteria:\n - Women who are pregnant or lactating\n - Presence of brain metastases\n - Prior therapy with rapamycin, rapamycin analogues or tacrolimus\n - Prior anticancer treatment (chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifiers, signal transduction inhibitors, etc) within 4 weeks prior to the first dose of ridaforolimus\n - Ongoing toxicity associated with prior anticancer therapy (except peripheral neuropathy of ≤ grade 1 by National Cancer Institute (NCI) toxicity criteria)\n - Another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinoma in situ)\n - Known or suspected hypersensitivity to drugs formulated with polysorbate 80 (Tween) or any other excipient contained in the study drug\n - Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin)\n - Significant uncontrolled cardiovascular disease\n - Active infection requiring systemic therapy\n - Known human immunodeficiency virus (HIV) infection\n - Treatment with any investigational agent within 4 weeks prior to the first dose of ridaforolimus\n - Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for 2 weeks prior to first planned dose of study drug\n - Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of ridaforolimus\n - Presence of any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluating the safety of the study drug\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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36
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[
{
"role": "user",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the disease, gene, demographic, and other relevant factors to assessing the relevance. Be as accurate as possible in your evaluation.\n\n**Clinical Trial Title:**\n\nA Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma\n\n**Clinical Trial Summary:**\n\nThe purpose of the study is to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin for which neutropenia (low white blood cell counts) could be managed with filgrastim (a Granulocyte-Colony Stimulation Factor that is used to help control neutropenia) in patients with a type of cancer called soft tissue sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nThis is a multicenter, open-label (identity of the assigned study treatments will be known to patients and study staff) study to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin for which the neutropenia (low white blood cell counts) is manageable with the use of filgrastim (an agent used to manage neutropenia) and associated with clinically acceptable number of side effects severe enough to continuation of treatment in patients with recurrent or persistent soft tissue sarcoma (STS, a malignant tumor that attacks the body's infrastructure of fat, muscles, nerves, joints, blood vessels, or deep skin tissues). Patients will be enrolled in the study after all study-specific entry criteria are met and informed consent is obtained. Patients will be required to attend regular clinic visits to receive study medication and have their status monitored. A detailed explanation can be provided by the study physician (Investigator) conducting this study. Doxorubicin (50 to 75 mg/m2) will be given as a 10-15 minute intravenous (i.v.) infusion on Day 1 via a central venous catheter which is a tube placed into a large vein. Trabectedin (0.9 to 1.3 mg/m2) will be given as a 3 hour i.v. infusion, immediately following the administration of doxorubicin. Dexamethasone 20 mg will be given within 1 hour before the start of each doxorubicin i.v. infusion and filgrastim will be administered according to manufacturer's instructions.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\n - Have a diagnosis of soft tissue sarcoma, recurrent or persistent\n - Signed informed consent obtained for all patients before performing any study-related procedures\n Exclusion Criteria:\n - Patients treated with more than 1 prior chemotherapy regimen (including adjuvant (or other additional) therapy)\n - Previous exposure to anthracyclines (a class of drugs used in cancer chemotherapy, example is Doxorubicin) or trabectedin\n - Less than 4 weeks since radiation therapy\n - Known metastases (spread) of cancer to the central nervous system\n - Other ongoing serious illness present at the time of enrollment as determined by the Investigator\n\n**Patient Description:** \n\n- Disease: Liposarcoma\n- Gene: CDK4 Amplification\n- Demographic: 38-year-old male\n- Other: GERD\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patient's disease, gene, demographic, and other factors in relation to the Eligibility Criteria, and other sections of the Clinical Trial Report.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
| Links | |
|---|---|
| Homepage: | TREC |
| Paper: | 2017 / 2018 / 2019 / 2020 |
| Contact (Original Authors): | Kirk Roberts ([email protected] ) |
| Contact (Curator): | Artur Guimarães ([email protected]) |
This track focused on oncologists looking for evidence-based treatment literature and clinical trials.
{
"query_id":"1",
"disease":"melanoma",
"gene":"BRAF (E586K)",
"demographic":"64-year-old female",
"doc_id":"NCT00001685",
"relevance":0,
"iteration":"0"
}
TO:DO
TO:DO
@inproceedings{roberts2017overview,
title={Overview of the TREC 2017 precision medicine track},
author={Roberts, Kirk and Demner-Fushman, Dina and Voorhees, Ellen M and Hersh, William R and Bedrick, Steven and Lazar, Alexander J and Pant, Shubham},
booktitle={The... text REtrieval conference: TREC. Text REtrieval Conference},
volume={26},
pages={https--trec},
year={2017}
}
@inproceedings{roberts2018overview,
title={Overview of the TREC 2018 Precision Medicine Track},
author={Roberts, Kirk and Demner-Fushman, Dina and Voorhees, Ellen M and Hersh, William R and Bedrick, Steven and Lazar, Alexander J},
booktitle={27th Text REtrieval Conference, TREC 2018},
year={2018}
}
@inproceedings{roberts2019overview,
title={Overview of the TREC 2019 precision medicine track},
author={Roberts, Kirk and Demner-Fushman, Dina and Voorhees, Ellen M and Hersh, William R and Bedrick, Steven and Lazar, Alexander J and Pant, Shubham and Meric-Bernstam, Funda},
booktitle={The... Text REtrieval Conference: TREC. Text REtrieval Conference},
volume={1250},
pages={https--trec},
year={2019}
}
@inproceedings{roberts2020overview,
title={Overview of the TREC 2020 precision medicine track},
author={Roberts, Kirk and Demner-Fushman, Dina and Voorhees, Ellen M and Bedrick, Steven and Hersh, William R},
booktitle={The... text REtrieval conference: TREC. Text REtrieval Conference},
volume={1266},
pages={https--trec},
year={2020}
}
Thanks to araag2 for adding this dataset.