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{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nRadiation Therapy With or Without Chemotherapy in Treating Patients With Anaplastic Oligodendroglioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.\r Combining chemotherapy with radiation therapy may kill more tumor cells.\r\n\r PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or\r without chemotherapy in treating patients who have anaplastic oligodendroglioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Compare the overall survival and time to tumor progression in patients with unifocal or\r multifocal, supratentorial, pure or mixed anaplastic oligodendroglioma treated with\r radiotherapy with or without procarbazine, lomustine, and vincristine (PCV).\r\n\r - Compare the toxic effects of these 2 regimens in these patients.\r\n\r - Compare the quality of life and neurologic function of patients treated with these 2\r regimens.\r\n\r OUTLINE: This is a randomized study. Patients are stratified by age (under 50 vs 50 and\r over), Karnofsky performance status (60-70% vs 80-100%), and tumor grade (moderately vs\r highly anaplastic). Within 8 weeks after diagnostic surgery, patients are randomized to 1 of\r 2 treatment arms.\r\n\r - Arm I: Within 2 weeks after randomization, patients receive oral lomustine on day 1,\r oral procarbazine on days 8-21, and vincristine IV on days 8 and 29 (PCV). Treatment\r continues every 6 weeks for 4 courses in the absence of disease progression or\r unacceptable toxicity. Beginning within 6 weeks after day 29 of course 4, patients\r undergo radiotherapy 5 days a week for 5.6 weeks followed by boost radiotherapy 5 days a\r week for 1 week.\r\n\r - Arm II: Within 2 weeks after randomization, patients undergo radiotherapy as in arm I.\r\n\r Quality of life is assessed at baseline; at time of CT or MRI scans during study; and every 3\r months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually\r thereafter after completion of study therapy.\r\n\r Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months\r for 3 years, and then annually thereafter.\r\n\r PROJECTED ACCRUAL: A total of 292 patients (146 per arm) will be accrued for this study\r within 5.4 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically proven unifocal or multifocal, supratentorial, pure or mixed anaplastic\r oligodendroglioma\r\n\r - Prior suspected or proven low-grade glioma allowed if current histologic proof of\r pure or mixed anaplastic oligodendroglioma\r\n\r - Tumor must contain an unequivocal (at least 25%) oligodendroglial element and have 2\r or more anaplastic features, 1 of which must be frequent mitoses or endothelial\r proliferation\r\n\r - For mixed tumors, the non-oligodendroglial element must be astrocytic and the\r oligodendroglial or astroglial component may be anaplastic\r\n\r - No evidence of spinal drop metastasis or spread to noncontiguous meninges\r\n\r - MRI of spine not required for asymptomatic patients and patients not excluded\r based on pathologic evidence of local meningeal infiltration by underlying tumor\r\n\r - No tumor that is predominantly located in the posterior fossa (i.e., brainstem or\r cerebellum)\r\n\r - No spinal cord tumors\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - Not specified\r\n\r Hematopoietic:\r\n\r - Absolute granulocyte count at least 1,500/mm^3\r\n\r - Platelet count at least 150,000/mm^3\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 2 times normal\r\n\r - Serum glutamate oxaloacetate transaminase (SGOT) no greater than 2 times normal\r\n\r - Alkaline phosphatase no greater than 2 times normal\r\n\r Renal:\r\n\r - Creatinine no greater than 1.5 times normal\r\n\r Pulmonary:\r\n\r - No chronic lung disease unless diffusion capacity of lung for carbon monoxide (DLCO)\r is at least 60% predicted\r\n\r Other:\r\n\r - No active infection\r\n\r - No other malignancy within the past 5 years except nonmelanomatous skin cancer or\r carcinoma in situ of the cervix\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - Not specified\r\n\r Chemotherapy:\r\n\r - No prior chemotherapy\r\n\r Endocrine therapy:\r\n\r - No concurrent steroids as antiemetics\r\n\r - Concurrent steroids allowed to control central nervous system (CNS) symptoms due to\r tumor-associated or radiotherapy-associated cerebral edema\r\n\r Radiotherapy:\r\n\r - No prior radiotherapy to brain or head/neck\r\n\r Surgery:\r\n\r - Prior surgery allowed\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
1 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nRadiation Therapy in Treating Patients With Brain Cancer\n\n**Clinical Trial Summary:**\n\nRATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an\r effective treatment for patients with anaplastic astrocytomas.\r\n\r PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in\r treating patients with anaplastic astrocytomas.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Compare the disease-free interval and survival in patients with supratentorial\r malignant brain gliomas randomized to radiotherapy alone vs. radiotherapy plus\r radiosensitization with mitolactol (DBD) followed by DBD and carmustine.\r\n\r OUTLINE: Randomized study. Group I: Radiotherapy. External-beam cranial irradiation with\r megavoltage equipment. Group II: Radiotherapy with Radiosensitization followed by Maintenance\r Chemotherapy. Radiotherapy as in Group I; with Mitolactol, DBD, NSC-104800; followed by DBD;\r Carmustine, BCNU, NSC-409962.\r\n\r PROJECTED ACCRUAL: A total of 212 patients will be entered over more than 3 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically confirmed anaplastic astrocytoma Standard maximum\r resection or stereotactic biopsy required within 4 weeks prior to therapy\r\n\r PATIENT CHARACTERISTICS: Age: Over 16 Performance status: ECOG/ZUBROD/WHO 0-2 Life\r expectancy: At least 8 weeks Hematopoietic: WBC greater than 4,000 Platelets greater than\r 100,000 Hematocrit greater than 30% Hepatic: Bilirubin less than 2 mg/dl Renal: Creatinine\r less than 1.5 mg/dl Creatinine clearance greater than 70 ml/min BUN less than 40 mg/dl\r Other: No major medical illness\r\n\r PRIOR CONCURRENT THERAPY: No anticancer drugs between surgery and protocol treatment No\r steroids after 10 days following surgery (may be resumed occasionally during radiotherapy)\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
2 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nChemotherapy Followed by Radiation Therapy in Treating Adults With Supratentorial Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.\r Combining radiation therapy with chemotherapy may kill more tumor cells.\r\n\r PURPOSE: Phase II trial to study the effectiveness of procarbazine, lomustine, and\r vincristine followed by radiation therapy in treating adults who have supratentorial glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Estimate the response rate of patients with newly diagnosed supratentorial\r low-grade glioma following neoadjuvant chemotherapy with PCV\r (procarbazine/lomustine/vincristine). II. Describe the toxicity of PCV. III. Determine the\r incidence of disease progression in these patients during PCV treatment.\r\n\r OUTLINE: The following acronyms are used: CCNU Lomustine, NSC-79037 PCB Procarbazine,\r NSC-77213 PCV PCB/CCNU/VCR VCR Vincristine, NSC-67574 3-Drug Combination Chemotherapy\r Followed by Radiotherapy. PCV; followed by external-beam cranial irradiation using at least 6\r MV photons.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically confirmed supratentorial * grade I/II glioma,\r including: Diffuse fibrillary astrocytoma No pilocytic astrocytoma No mixed tumor with\r ependymoma elements * Supratentorial sites include: Frontal, temporal, parietal, or\r occipital lobes Thalamus, basal ganglia, or midbrain Lateral or third ventricles Pons,\r medulla, or optic chiasm tumors allowed only if secondary to eligible tumor More than 1\r separate tumor allowed Diagnosis based on surgical biopsy or subtotal resection Measurable\r or evaluable disease on T2-weighted MRI required\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: WBC\r greater than 3,500/mm3 Platelet count greater than 130,000/mm3 Hemoglobin greater than 9\r g/dL Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) AST less than 2 times\r ULN Alkaline phosphatase less than 2 times ULN Renal: Creatinine less than 1.5 times ULN\r Other: No active or uncontrolled infection No second malignancy within 3 years except:\r Nonmelanomatous skin cancer In situ cervical cancer No pregnant or nursing women Negative\r pregnancy test required within 7 days prior to entry Effective contraception required of\r fertile patients\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior\r chemotherapy Endocrine therapy: At least 1 week since prior steroids OR Stable steroid dose\r for at least 1 week prior to study Radiotherapy: No prior cranial or head and neck\r irradiation Surgery: See Disease Characteristics\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
3 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nCombination Chemotherapy for Patients With Brain Cancer\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Combining more than one drug may kill more tumor cells.\r\n\r PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy using\r paclitaxel and topotecan, plus G-CSF, in treating patients with glioblastoma multiforme or\r anaplastic astrocytoma that is refractory or recurrent.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the response rate in patients with refractory or recurrent\r glioblastoma multiforme or anaplastic astrocytoma treated with paclitaxel (TAX) and topotecan\r (TOPO) with granulocyte colony-stimulating factor (G-CSF) support. II. Determine survival in\r these patients. III. Describe the toxicity of TAX/TOPO/G-CSF. IV. Evaluate tumor p53\r expression in relation to response to TAX/TOPO/G-CSF.\r\n\r OUTLINE: All patients receive paclitaxel, topotecan, and G-CSF every 3 weeks for at least 2\r courses and until 2 courses beyond maximum response. Patients are followed every 3 months for\r 2 years, then every 6 months for relapse and survival.\r\n\r PROJECTED ACCRUAL: A total of 35 patients will be entered if there are 1-3 responses in the\r first 20 patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Biopsy proven glioblastoma multiforme or anaplastic astrocytoma\r Central pathologic review at Dartmouth-Hitchcock Medical Center, including assay for tumor\r p53 expression No anaplastic oligodendroglioma No mixed oligodendroastrocytoma Recurrent or\r progressive disease following radiotherapy documented by CT or MRI within 2 weeks of entry\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100%\r Hematopoietic: WBC at least 3,000 ANC at least 1,500 Platelets at least 100,000 Hepatic:\r Bilirubin no greater than 1.0 mg/dL AST/ALT no greater than 2.5 times normal Renal:\r Creatinine no greater than 1.5 mg/dL Other: No documented sensitivity to E. coli-derived\r products No major medical or psychiatric illness that would interfere with therapy or\r compliance with scheduled follow-up No pregnant or nursing women Adequate contraception\r required of fertile patients\r\n\r PRIOR CONCURRENT THERAPY: No prior taxanes or topoisomerase I inhibitors At least 4 weeks\r since chemotherapy (6 weeks since nitrosoureas) At least 4 weeks since radiotherapy\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
4 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nMonoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer\n\n**Clinical Trial Summary:**\n\nRATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver\r tumor-killing substances to them without harming normal cells.\r\n\r PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating\r patients who have leptomeningeal metastases.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Define the clinical toxicities of intrathecal iodine I 131 monoclonal antibody 3F8\r (I-3F8) in patients with GD2 positive leptomeningeal neoplasms.\r\n\r - Determine whether I-3F8 can detect GD2 positive leptomeningeal tumors.\r\n\r - Measure the cerebrospinal fluid (CSF) levels and serum pharmacokinetics of I-3F8 in\r these patients.\r\n\r OUTLINE: This is a dose escalation study.\r\n\r Patients receive a single injection of intraventricular or intrathecal iodine I 131\r monoclonal antibody 3F8. Patients without objective disease progression and no grade 3 or 4\r toxicity 6 weeks after the first dose may receive a second injection.\r\n\r Cohorts of at least 3 patients are entered at escalating doses of I-3F8. If grade 3 or worse\r toxicity occurs in 1 or more of 3 patients at a given dose level, then 3 additional patients\r are accrued at that level. If 2 or more of 6 patients at a given dose level experience grade\r 3 or worse toxicity, then that dose is declared the maximum tolerated dose (MTD).\r\n\r Patients are followed weekly for 4 weeks.\r\n\r PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study over 2-3 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed malignancy expressing GD2, including, but not limited to:\r\n\r - Medulloblastoma/primitive neuroectodermal tumor of the CNS\r\n\r - Malignant glioma\r\n\r - Neuroblastoma\r\n\r - Retinoblastoma\r\n\r - Ependymoma\r\n\r - Sarcoma\r\n\r - Melanoma\r\n\r - Small cell lung carcinoma\r\n\r - Other tumor types must have GD2 expression confirmed by immunohistochemical\r staining\r\n\r - Cerebrospinal fluid or leptomeningeal disease that is refractory to conventional\r therapy or for which no conventional therapy exists\r\n\r - Prior measurable human anti-mouse monoclonal antibody titer allowed\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 3 and over\r\n\r Performance status:\r\n\r - Not specified\r\n\r Life expectancy:\r\n\r - At least 2 months\r\n\r Hematopoietic:\r\n\r - Absolute neutrophil count greater than 1,000/mm^3\r\n\r - Platelet count greater than 50,000/mm^3\r\n\r Hepatic:\r\n\r - Bilirubin less than 3 mg/dL\r\n\r Renal:\r\n\r - Creatinine less than 2 mg/dL\r\n\r - Blood urea nitrogen less than 30 mg/dL\r\n\r Other:\r\n\r - May have active malignancy outside the central nervous system\r\n\r - No obstructive hydrocephalus\r\n\r - No CNS grade 3 or 4 toxicity as a consequence of prior treatments\r\n\r - No life threatening infection\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - Prior monoclonal antibody treatment allowed\r\n\r Chemotherapy:\r\n\r - Prior chemotherapy allowed\r\n\r - Must have recovered from all hematopoietic and neurologic side effects of prior\r chemotherapy\r\n\r Endocrine therapy:\r\n\r - Not specified\r\n\r Radiotherapy:\r\n\r - Prior radiotherapy allowed\r\n\r - At least 6 weeks since prior cranial or spinal irradiation\r\n\r Surgery:\r\n\r - Not specified\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
5 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nTemozolomide and Carmustine in Treating Patients With Anaplastic Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Combining more than one drug may kill more tumor cells.\r\n\r PURPOSE: Phase II trial to study the effectiveness of temozolomide and carmustine in treating\r patients with anaplastic glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Evaluate the activity, measured in terms of progression free survival, of\r carmustine plus temozolomide in recurrent glioblastoma. II. Estimate the response rate of\r recurrent glioblastomas to this combination. III. Estimate the response rate of newly\r diagnosed anaplastic astrocytomas and mixed anaplastic glioma to this combination. IV.\r Evaluate the qualitative and quantitative toxicities of this combination in patients with\r anaplastic gliomas.\r\n\r OUTLINE: This is a nonrandomized study. Patients are stratified by disease (recurrent\r glioblastoma vs anaplastic astrocytoma or mixed anaplastic glioma). Patients receive\r carmustine intravenously on day 1 two hours prior to temozolomide. Temozolomide is\r administered orally on day 1. Cycles repeat every 42 days. Treatment for patients with\r recurrent glioblastoma may continue for 8 cycles in the absence of disease progression or\r unacceptable toxicity. If there is no disease progression after 8 cycles, treatment may\r continue further at the investigator's discretion. Patients with anaplastic astrocytoma or\r mixed anaplastic glioma continue for 4 cycles of treatment. Patients are followed\r periodically at the investigator's discretion, at least twice in the first 4 months, and then\r until death.\r\n\r PROJECTED ACCRUAL: A minimum of 17 patients and a maximum of 37 patients will be accrued in\r the recurrent glioblastoma stratum and 45 patients will be accrued into the anaplastic\r astrocytoma and mixed anaplastic glioma stratum.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically confirmed malignant glioma - Recurrent glioblastoma\r - Anaplastic astrocytoma - Mixed anaplastic glioma For recurrent glioblastoma: Required\r documented progression must include an increase in tumor size of at least 25% or appearance\r of new lesion For anaplastic astrocytoma or mixed anaplastic glioma: Must have measurable,\r contrast enhancing disease on postoperative CT or MRI scan No postoperative radiation or\r chemotherapy If patients have received prior brachytherapy or stereotactic radiosurgery,\r they must have confirmation of true progressive disease rather than radiation necrosis by\r PET scanning or biopsy\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life\r expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count\r at least 1,800/mm3 Platelet count at least 125,000/mm3 Hemoglobin at least 9 g/dL\r (transfusion allowed) Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2.0 times upper\r limit of normal Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than\r 70 mL/min Cardiovascular: No uncontrolled arrhythmias or conduction defects No unstable or\r newly diagnosed angina pectoris No New York Heart Association class II-IV heart disease No\r congestive heart failure No major problems with edema (e.g., severe Cushing's syndrome,\r residual leg swelling from deep-vein thrombosis) No recent coronary artery disease No\r poorly controlled hypertension (diastolic greater than 110 mmHg and systolic greater than\r 180 mmHg) Pulmonary: DLCO greater than 80% of expected value Other: HIV negative No major\r psychiatric illness No other prior malignancy except adequately treated basal cell or\r squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer\r from which the patient is currently in complete remission, or any other cancer from which\r the patient has been free of disease for 5 years Not pregnant or nursing Adequate\r contraception required of all fertile patients\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No\r prior nitrosourea or temozolomide No more than 1 prior chemotherapy regimen allowed for\r patients with glioblastoma At least 6 weeks since mitomycin or procarbazine and recovered\r At least 4 weeks since other prior chemotherapy and recovered No other concurrent\r chemotherapy Endocrine therapy: If receiving steroids, must be on a stable steroid dose for\r at least 72 hours prior to study No other concurrent endocrine therapy Radiotherapy: At\r least 6 weeks since radiotherapy No greater than 10-20% of marrow irradiated in prior\r radiotherapy No other concurrent radiotherapy Surgery: Surgery allowed\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
6 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nTopotecan in Treating Patients With Recurrent Brain Tumors\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die.\r\n\r PURPOSE: Phase II trial to study the effectiveness of topotecan in treating patients with\r recurrent brain tumor.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the efficacy of topotecan in patients with recurrent anaplastic\r oligodendroglioma or anaplastic mixed oligoastrocytoma. II. Determine the qualitative and\r quantitative toxicity of topotecan in this patient population on this schedule.\r\n\r OUTLINE: This is a multicenter study. Patients receive intravenous topotecan over 30 minutes\r daily for 5 days every 3 weeks. Treatment continues in the absence of disease progression or\r unacceptable toxicity. Patients will be followed every 3 months until death.\r\n\r PROJECTED ACCRUAL: Up to 30 evaluable patients will be accrued within 2-3 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically proven recurrent anaplastic oligodendroglioma or\r anaplastic mixed oligoastrocytoma following primary surgery and radiation therapy Tumors\r for anaplastic mixed oligoastrocytoma must contain at least 25% oligodendroglial elements\r Tumors must be clinically aggressive for patients with only 1 anaplastic feature Prior low\r grade oligodendrogliomas or oligoastrocytomas undergoing repeat biopsy following clinical\r or radiological progression are eligible Bidimensionally measurable and progressive lesions\r by CT or MRI\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not\r specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at\r least 100,000/mm3 Hepatic: Not specified Renal: Creatinine normal Other: Not pregnant or\r nursing Fertile patients must use effective contraception No prior malignancies except\r curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer No other\r serious illness or medical condition No active uncontrolled infection No history of\r neurologic or psychiatric disorder\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks\r since chemotherapy No more than 1 prior chemotherapy regimen No prior camptothecin\r derivatives Endocrine therapy: At least 2 weeks on stable steroid therapy, if necessary\r Radiotherapy: At least 2 months since prior radiotherapy No prior radiation therapy for\r recurrent disease Surgery: At least 6 weeks since prior surgery (except biopsy only) Prior\r surgery for recurrent disease allowed (including stereotactic biopsy or partial resection)\r Other: No concurrent experimental drugs or anticancer therapy\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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7 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nObservation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in\r chemotherapy use different ways to stop tumor cells from dividing so they stop growing or\r die. It is not yet known whether radiation therapy combined with chemotherapy is more\r effective than radiation therapy alone in treating patients with low-grade glioma.\r\n\r PURPOSE: Phase II/III trial to evaluate observation and to compare the effectiveness of\r radiation therapy with or without combination chemotherapy in treating patients with\r low-grade glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Identify the overall survival of low-risk adult patients with supratentorial low-grade\r glioma who are observed postoperatively.\r\n\r - Compare the overall survival of high-risk adult patients with supratentorial low-grade\r glioma who receive postoperative external beam radiotherapy with or without\r procarbazine, lomustine, and vincristine (PCV) chemotherapy.\r\n\r - Compare the toxic effects of postoperative radiotherapy with or without PCV chemotherapy\r in patients with unfavorable low-grade glioma.\r\n\r OUTLINE: This is a randomized study. Patients are stratified according to tumor subtype\r (astrocytoma [mixed-astro dominant or equal astro/oligo mix] vs oligodendroglioma\r [mixed-oligo dominant]), age (younger than 40 vs at least 40), Karnofsky performance status\r (60-80% vs 90-100%), and contrast enhancement on preoperative scan (present vs absent).\r Patients with low-risk disease (younger than 40 years old whose tumors have been surgically\r removed) are assigned to arm I. Patients with high-risk disease (at least 40 years old or who\r have had incomplete tumor removal) are randomized to arm II or III.\r\n\r - Arm I (low-risk patients): Patients are observed. Patients may receive treatment if\r tumor recurs.\r\n\r - Arm II (high-risk patients): Patients receive daily external beam radiotherapy 5 days a\r week for 6 weeks.\r\n\r - Arm III (high-risk patients): Patients receive radiotherapy as in arm II followed by\r chemotherapy 1 month later. Chemotherapy consists of oral lomustine on day 1,\r vincristine IV on days 8 and 29, and oral procarbazine on days 8-21. Each course of\r chemotherapy lasts 8 weeks. Patients may receive up to 6 courses of chemotherapy.\r\n\r Patients are followed every 4 months for 1 year, every 6 months for 2 years, and then\r annually thereafter.\r\n\r PROJECTED ACCRUAL: Approximately 252 patients will be accrued within 5.25 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed unifocal or multifocal supratentorial WHO grade II\r astrocytoma (diffuse fibrillary, protoplasmic, or gemistocytic), oligodendroglioma, or\r oligoastrocytoma\r\n\r - Patients with neurofibromatosis are eligible\r\n\r - No other low-grade histologies, including:\r\n\r - Pilocytic astrocytoma\r\n\r - Subependymal giant cell astrocytoma of tuberous sclerosis\r\n\r - Subependymoma\r\n\r - Pleomorphic xanthoastrocytoma\r\n\r - Presence of a neuronal element such as ganglioglioma\r\n\r - Dysneuroembryoplastic epithelial tumor\r\n\r - No presence of any high-grade glioma, including:\r\n\r - Anaplastic astrocytoma\r\n\r - Glioblastoma multiforme\r\n\r - Anaplastic oligodendroglioma\r\n\r - Anaplastic oligoastrocytoma\r\n\r - No tumors in nonsupratentorial or other locations including optic chiasm, optic\r nerve(s), pons, medulla, cerebellum, or spinal cord\r\n\r - No evidence of spread to spinal meninges or noncontiguous cranial meninges (i.e.,\r leptomeningeal gliomatosis)\r\n\r - No gliomatosis cerebri\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Hematopoietic:\r\n\r - For high-risk patients:\r\n\r - Granulocyte count at least 1,500/mm^3\r\n\r - Platelet count normal\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 2 times normal\r\n\r - SGOT or SGPT no greater than 4 times normal\r\n\r - Alkaline phosphatase no greater than 2 times normal\r\n\r Renal:\r\n\r - Creatinine no greater than 2 times normal\r\n\r Pulmonary:\r\n\r - No chronic lung disease (unless DLCO at least 60%)\r\n\r Neurological:\r\n\r - Neurologic function score no greater than 3\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Fertile patients must use effective contraception\r\n\r - No other malignancy within the past 5 years except carcinoma in situ of the cervix or\r nonmelanoma skin cancer\r\n\r - No active infection\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - Not specified\r\n\r Chemotherapy:\r\n\r - No prior chemotherapy\r\n\r Endocrine therapy:\r\n\r - Not specified\r\n\r Radiotherapy:\r\n\r - No prior radiotherapy to the head or neck (unless brain is clearly excluded, such as\r radiotherapy for localized vocal cord cancer)\r\n\r Surgery:\r\n\r - Not specified\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
8 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nTemozolomide in Treating Patients With Anaplastic Oligodendroglioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die.\r\n\r PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with\r anaplastic oligodendroglioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the activity of temozolomide in patients with newly diagnosed,\r progressive, or recurrent anaplastic oligodendroglioma. II. Determine the toxicity of this\r drug in this patient population.\r\n\r OUTLINE: Patients are stratified according to disease characteristics (newly diagnosed\r anaplastic oligodendroglioma versus recurrent anaplastic oligodendroglioma). Patients receive\r oral temozolomide once daily on days 1-5. Treatment repeats every 28 days. Patients with\r progressive or recurrent disease (at baseline) continue treatment in the absence of disease\r progression or unacceptable toxicity. Patients with newly diagnosed disease continue\r treatment for a maximum of 4 courses before radiotherapy in the absence of disease\r progression or unacceptable toxicity. Patients with responding disease may receive an\r additional 6 courses after completion of radiotherapy. (Radiotherapy is not part of study\r treatment.) Patients are followed every 8 weeks for 2 years.\r\n\r PROJECTED ACCRUAL: A maximum of 60 patients (30 per stratum) will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically confirmed supratentorial anaplastic\r oligodendroglioma or anaplastic oligoastrocytoma not requiring immediate radiotherapy Newly\r diagnosed, progressive, or recurrent disease Bidimensionally measurable disease At least\r 1.5 cm2 by MRI\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life\r expectancy: More than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet\r count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5\r times upper limit of normal (ULN) SGOT/SGPT less than 2.5 times ULN Alkaline phosphatase\r less than 2 times ULN Renal: BUN less than 1.5 times ULN Creatinine less than 1.5 times ULN\r Other: Neurologically stable No nonmalignant systemic disease No acute infection treated\r with intravenous antibiotics No frequent vomiting No medical condition (e.g., partial bowel\r obstruction) that would interfere with oral medication intake No other prior or concurrent\r malignancy except surgically cured carcinoma in situ of the cervix or basal cell or\r squamous cell carcinoma of the skin No AIDS-related illness HIV negative Not pregnant or\r nursing Negative pregnancy test Fertile patients must use effective contraception\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior biologic therapy No\r concurrent biologic therapy No concurrent growth factors (e.g., epoetin alfa) Chemotherapy:\r No more than 1 prior chemotherapy regimen No other concurrent chemotherapy Endocrine\r therapy: Must be on stable dose of steroids for at least 1 week prior to study Concurrent\r steroids allowed Radiotherapy: See Disease Characteristics No concurrent radiotherapy\r Surgery: At least 2 weeks since prior surgical resection (newly diagnosed patients must be\r enrolled within 28 days of surgery or biopsy) Recovered from prior major surgery Other: No\r other concurrent investigational drugs\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
9 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nTemozolomide in Treating Patients With Progressive Low-Grade Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die.\r\n\r PURPOSE: This phase II trial is studying how well temozolomide works in treating patients\r with progressive low-grade glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Assess the response rate in patients with progressive low-grade gliomas treated with\r temozolomide.\r\n\r - Determine the activity of this drug, in terms of stabilizing growth of progressive\r low-grade gliomas, in adult patients.\r\n\r OUTLINE: Patients are stratified by disease type (pilocytic astrocytoma, mixed glioma,\r well-differentiated oligodendroglioma, and nonbiopsied optic pathway glioma or pontine\r glioma).\r\n\r Patients receive temozolomide orally once daily on days 1-5. Courses repeat every 28 days. In\r the absence of disease progression or unacceptable toxicity, patients may continue with\r treatment until tumor has remained stable for 12 courses.\r\n\r Patients are followed every 8-12 weeks for 2 years.\r\n\r PROJECTED ACCRUAL: A total of 36-100 patients (9-25 per stratum) will be accrued for this\r study within 3 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade\r glioma including:\r\n\r - Astrocytoma\r\n\r - Oligodendroglioma\r\n\r - Mixed glioma\r\n\r - Optic pathway glioma*\r\n\r - Pontine glioma* NOTE: *Biopsy not required\r\n\r - Patients with optic pathway glioma must also meet the following criteria:\r\n\r - Progressive loss of vision as defined by doubling of octaves\r\n\r - Visual acuity loss not explained by other causes\r\n\r - Increase in proptosis of greater than 3 mm\r\n\r - Increase in diameter of optic nerve of at least 2 mm on neuroimaging\r\n\r - Increase in distribution of tumor involving optic tracts or optic radiations as\r indicated by CT scan or MRI\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 4 and over\r\n\r Performance status:\r\n\r - Karnofsky 70-100%\r\n\r Life expectancy:\r\n\r - More than 12 weeks\r\n\r Hematopoietic:\r\n\r - Absolute neutrophil count at least 1,500/mm^3\r\n\r - Platelet count at least 100,000/mm^3\r\n\r - Hemoglobin at least 10 g/dL\r\n\r Hepatic:\r\n\r - Bilirubin less than 1.5 times upper limit of normal (ULN)\r\n\r - SGOT and SGPT less than 2.5 times ULN\r\n\r - Alkaline phosphatase less than 2 times ULN\r\n\r Renal:\r\n\r - Creatinine less than 1.5 times ULN\r\n\r - BUN less than 1.5 times ULN\r\n\r Other:\r\n\r - Must be neurologically stable\r\n\r - No systemic disease\r\n\r - No acute infection requiring IV antibiotics\r\n\r - No frequent vomiting\r\n\r - No other medical condition that would interfere with oral medication (e.g., partial\r bowel obstruction)\r\n\r - No other prior or concurrent malignancies except:\r\n\r - Surgically cured carcinoma in situ of the cervix\r\n\r - Basal or squamous cell skin cancer\r\n\r - HIV negative\r\n\r - No AIDS-related illness\r\n\r - Not pregnant or nursing\r\n\r - Fertile patients must use effective contraception\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - No concurrent biologic therapy (growth factors or epoetin alfa)\r\n\r Chemotherapy:\r\n\r - At least 6 weeks since prior chemotherapy unless evidence of disease progression\r\n\r - No other concurrent chemotherapy\r\n\r Endocrine therapy:\r\n\r - Not specified\r\n\r Radiotherapy:\r\n\r - At least 6 weeks since prior radiotherapy unless evidence of disease progression\r\n\r - No concurrent radiotherapy\r\n\r Surgery:\r\n\r - At least 3 weeks since prior surgery unless evidence of disease progression\r\n\r - Recovered from all prior surgery\r\n\r Other:\r\n\r - No other concurrent investigational drugs\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
10 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAntineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Current therapies for adults with anaplastic astrocytomas that have not responded\r to standard therapy provide very limited benefit to the patient. The anti-cancer properties\r of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults\r with anaplastic astrocytomas that have not responded to standard therapy.\r\n\r PURPOSE: This study is being performed to determine the effects (good and bad) that\r Antineoplaston therapy has on adults with anaplastic astrocytomas that have not responded to\r standard therapy.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - To determine the efficacy of Antineoplaston therapy in patients with anaplastic\r astrocytomas that have not responded to standard therapy, as measured by an objective\r response to therapy (complete response, partial response or stable disease).\r\n\r - To determine the safety and tolerance of Antineoplaston therapy in patients with a\r anaplastic astrocytoma\r\n\r OVERVIEW: This is a single arm, open-label study in which adults withanaplastic astrocytomas\r that have not responded to standard therapy receive gradually escalating doses of intravenous\r Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached.\r Treatment continues for at least 12 months in the absence of disease progression or\r unacceptable toxicity. After 12 months, patients with a complete or partial response or with\r stable disease may continue treatment.\r\n\r To determine objective response, tumor size is measured utilizing MRI scans, which are\r performed every 8 weeks for the first two years, every 3 months for the third and fourth\r years, every 6 months for the 5th and sixth years, and annually thereafter.\r\n\r PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically or cytologically confirmed incurable adult anaplastic astrocytoma\r\n\r - Evidence of progressive or recurrent tumor by MRI scan performed within 2 weeks prior\r to study entry\r\n\r - Must have received and failed standard therapy\r\n\r - Tumor must be at least 5 mm\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - At least 2 months\r\n\r Hematopoietic:\r\n\r - WBC at least 2000/mm^3\r\n\r - Platelet count at least 50,000/mm^3\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 2.5 mg/dL\r\n\r - SGOT and SGPT no greater than 5 times upper limit of normal\r\n\r - No hepatic failure\r\n\r Renal:\r\n\r - Creatinine no greater than 2.5 mg/dL\r\n\r - No history of renal conditions that contraindicate high dosages of sodium\r\n\r Cardiovascular:\r\n\r - No uncontrolled hypertension\r\n\r - No history of congestive heart failure\r\n\r - No history of other cardiovascular conditions that contraindicate high dosages of\r sodium\r\n\r Pulmonary:\r\n\r - No serious lung disease such as severe chronic obstructive pulmonary disease\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Fertile patients must use effective contraception during and for 4 weeks after study\r\n\r - No active infection\r\n\r - No other serious concurrent disease\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - At least 4 weeks since prior immunotherapy and recovered\r\n\r - No concurrent immunomodulating agents\r\n\r Chemotherapy:\r\n\r - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered\r\n\r - No concurrent antineoplastic agents\r\n\r Endocrine therapy:\r\n\r - Concurrent corticosteroids allowed\r\n\r Radiotherapy:\r\n\r - At least 8 weeks since prior radiotherapy and recovered\r\n\r Surgery:\r\n\r - Fully recovered from any prior surgery\r\n\r Other:\r\n\r - Prior cytodifferentiating agent allowed\r\n\r - No prior antineoplaston therapy\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
11 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAntineoplaston Therapy in Treating Patients With Low-Grade Astrocytoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Current therapies for adult recurrent/progressive low grade astrocytoma provide\r limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest\r that it may prove beneficial in the treatment of adult recurrent/progressive low grade\r astrocytoma.\r\n\r PURPOSE: This study is being performed to determine the effects (good and bad) that\r Antineoplaston therapy has on adults with a recurrent/progressive low grade astrocytoma.\n\n**Clinical Trial Detailed Description:**\n\nOVERVIEW: This is a single arm, open-label study in which adults with a recurrent/progressive\r low grade astrocytoma receive gradually escalating doses of intravenous Antineoplaston\r therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment\r continues for at least 12 months in the absence of disease progression or unacceptable\r toxicity.\r\n\r OBJECTIVES:\r\n\r - To determine the efficacy of Antineoplaston therapy in adults with a\r recurrent/progressive low grade astrocytoma, as measured by an objective response to\r therapy (complete response, partial response or stable disease).\r\n\r - To determine the safety and tolerance of Antineoplaston therapy in adults with a\r recurrent/progressive low grade astrocytoma.\r\n\r - To determine objective response, tumor size is measured utilizing MRI scans, which are\r performed every 8 weeks for the first two years, every 3 months for the third and fourth\r years, every 6 months for the 5th and sixth years, and annually thereafter.\r\n\r PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically or cytologically confirmed low-grade astrocytoma that has progressed,\r recurred, or persisted after initial therapy, including radiotherapy\r\n\r - Previously treated with at least 1 prior standard therapy (e.g., radiotherapy,\r chemotherapy, immunotherapy, or cytodifferentiating agent)\r\n\r - Measurable tumor by MRI scan performed within two weeks prior to study entry\r\n\r - Tumor must be at least 5 mm\r\n\r - No brain stem tumors\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - More than 2 months\r\n\r Hematopoietic:\r\n\r - WBC at least 2,000/mm^3\r\n\r - Platelet count at least 50,000/mm^3\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 2.5 mg/dL\r\n\r - SGOT and SGPT no greater than 5 times upper limit of normal\r\n\r - No hepatic failure\r\n\r Renal:\r\n\r - Creatinine no greater than 2.5 mg/dL\r\n\r - No renal insufficiency\r\n\r - No history of renal conditions that contraindicate high dosages of sodium\r\n\r Cardiovascular:\r\n\r - No uncontrolled hypertension\r\n\r - No chronic heart failure\r\n\r - No history of congestive heart failure\r\n\r - No history of other cardiovascular conditions that contraindicate high dosages of\r sodium\r\n\r Pulmonary:\r\n\r - No severe lung disease (e.g., chronic obstructive pulmonary disease)\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Fertile patients must use effective contraception during and for 4 weeks after study\r participation\r\n\r - No other concurrent serious disease\r\n\r - No active infection\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - See Disease Characteristics\r\n\r - At least 4 weeks since prior immunotherapy and recovered\r\n\r - No concurrent immunomodulating agents\r\n\r Chemotherapy:\r\n\r - See Disease Characteristics\r\n\r - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered\r\n\r - No concurrent antineoplastic agents\r\n\r Endocrine therapy:\r\n\r - Concurrent corticosteroids allowed\r\n\r Radiotherapy:\r\n\r - See Disease Characteristics\r\n\r - At least 8 weeks since prior radiotherapy and recovered\r\n\r Surgery:\r\n\r - Must recover from prior surgery\r\n\r Other:\r\n\r - No prior antineoplastons\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
12 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAntineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Current therapies for adults with anaplastic astrocytoma provide limited benefit\r to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may\r prove beneficial in the treatment of adults with anaplastic astrocytoma.\r\n\r PURPOSE: This study is being performed to determine the effects (good and bad) that\r Antineoplaston therapy has on adults with anaplastic astrocytoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - To determine the efficacy of Antineoplaston therapy in adults with anaplastic\r astrocytoma as measured by an objective response to therapy (complete response, partial\r response) or stable disease.\r\n\r - To determine the safety and tolerance of Antineoplaston therapy in adults with\r anaplastic astrocytoma.\r\n\r OVERVIEW: This is a single arm, open-label study in which adults with anaplastic astrocytoma\r receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal +\r Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12\r months in the absence of disease progression or unacceptable toxicity. After 12 months,\r patients with a complete or partial response or with stable disease may continue treatment.\r\n\r To determine objective response, tumor size is measured utilizing MRI scans, which are\r performed every 8 weeks for the first two years, every 3 months for the third and fourth\r years, every 6 months for the 5th and sixth years, and annually thereafter.\r\n\r PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically or cytologically confirmed diagnosis of anaplastic astrocytoma\r\n\r - Tumor subtotally resected or biopsied prior to therapy\r\n\r - Evidence of residual tumor by MRI scan performed within two weeks prior to study entry\r\n\r - No brain stem tumors\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - More than 2 months\r\n\r Hematopoietic:\r\n\r - WBC at least 1,500/mm^3\r\n\r - Platelet count at least 50,000/mm^3\r\n\r - Hemoglobin at least 10 g/dL\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 2.5 mg/dL\r\n\r - SGOT and SGPT no greater than 5 times upper limit of normal\r\n\r - No hepatic failure\r\n\r Renal:\r\n\r - Creatinine no greater than 2.5 mg/dL\r\n\r - No renal failure\r\n\r Cardiovascular:\r\n\r - No prior congestive heart failure\r\n\r - No coronary artery disease\r\n\r - No myocardial infarction within the past year\r\n\r - No angina requiring medication\r\n\r - No uncontrolled hypertension\r\n\r Pulmonary:\r\n\r - No moderate to severe chronic obstructive pulmonary disease\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Fertile patients must use effective contraception during and for 4 weeks after study\r participation\r\n\r - No active infection\r\n\r - No other concurrent serious disease\r\n\r - No other prior malignancy except carcinoma in situ of the cervix or superficial\r nonmelanoma skin cancer\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - No prior immunotherapy\r\n\r - No concurrent immunomodulating agents\r\n\r Chemotherapy:\r\n\r - No prior myelosuppressive chemotherapy\r\n\r Endocrine therapy:\r\n\r - Concurrent corticosteroids for cerebral edema allowed\r\n\r Radiotherapy:\r\n\r - No prior myelosuppressive radiotherapy\r\n\r - No concurrent radiotherapy\r\n\r Surgery:\r\n\r - See Disease Characteristics\r\n\r - Recovered from any prior surgery\r\n\r Other:\r\n\r - No prior cytodifferentiating agents\r\n\r - No prior antineoplaston therapy\r\n\r - No other concurrent antineoplastic agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
13 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nProcarbazine and Isotretinoin in Treating Patients With Recurrent Primary Malignant Gliomas\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Combining more than one drug may kill more tumor cells. It is not\r yet known whether giving procarbazine alone or with isotretinoin is more effective for\r recurrent primary malignant glioma.\r\n\r PURPOSE: Randomized phase III trial to compare the effectiveness of procarbazine alone or\r with isotretinoin in treating patients with recurrent primary malignant gliomas.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine whether the combination of isotretinoin and procarbazine can improve\r time to progression and survival compared to procarbazine alone in patients with recurrent\r malignant gliomas. II. Document the toxicity of these two regimens in these patients.\r\n\r OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive\r procarbazine alone or in combination with isotretinoin. Arm I: Patients receive oral\r procarbazine once daily on days 1-14 every 28 days. Oral isotretinoin is administered every\r 12 hours on days 15-28 every 28 days. Patient receive 6 courses of combined therapy, then\r continue with oral isotretinoin alone on days 15-28 of each 28 day course, until disease\r progression or unacceptable toxicity. Arm II: Patients receive procarbazine by mouth once\r daily on days 1-14 followed by 2 weeks of rest. Patients receive a total of 6 courses of\r treatment in the absence of disease progression and unacceptable toxicity. Patients are\r followed until death.\r\n\r PROJECTED ACCRUAL: This study will accrue a total of 194 patients (97 per treatment group).\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically proven primary malignant gliomas including the\r following: Glioblastoma multiforme Gliosarcoma Anaplastic astrocytoma Anaplastic\r oligodendroglioma Anaplastic infiltrating glioma Mixed malignant gliomas Must show evidence\r of tumor recurrence or progression on at least 2 serial enhanced MRI scans Must have\r measurably enhancing residual disease on MRI or CT scan of brain\r\n\r PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 60-100% Life\r expectancy: Greater than 8 weeks Hematopoietic: Absolute granulocyte count at least\r 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGPT less than 2 times institutional\r normal Alkaline phosphatase less than 2 times institutional normal Bilirubin less than 1.5\r mg/dL Renal: BUN less than 1.5 times institutional normal OR Creatinine less than 1.5 times\r institutional normal Other: No active infection Not pregnant or nursing Fertile patients\r must use effective contraception 1 month before, during, and 1 month after study No other\r disease that will obscure toxicity or alter drug metabolism No other concurrent medical\r illness\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior\r procarbazine No prior isotretinoin At least 4 weeks since prior chemotherapy (6 weeks for\r nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: Prior\r radiotherapy allowed Surgery: Not specified Other: No concurrent tetracyclines\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
14 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nCombination Chemotherapy Plus Radiation Therapy in Treating Patients With Anaplastic Astrocytoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.\r Combining more than one drug with radiation therapy may kill more tumor cells.\r\n\r PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation\r therapy in treating patients who have newly diagnosed anaplastic astrocytoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the efficacy of carmustine, cisplatin, and etoposide given prior to\r and during radiotherapy in patients with anaplastic astrocytoma. II. Assess the toxic effects\r associated with this regimen in these patients. III. Evaluate this regimen in terms of\r fatigue, depression, excessive daytime somnolence, and quality of life in these patients.\r\n\r OUTLINE: Patients receive carmustine IV over 1 hour on days 1-3, oral etoposide on days 1-21\r and 29-49, and cisplatin IV over 1-2 hours on days 1-3 and 29-31. Treatment repeats every 8\r weeks for 3 courses. Patients receive radiotherapy concurrently with the third course of\r chemotherapy. Quality of life is assessed every 4 months for 1 year, every 6 months for 4\r years, and then annually for 5 years. Patients are followed every 3 months for 5 years and\r then annually thereafter.\r\n\r PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study within 20 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically confirmed, newly diagnosed, anaplastic astrocytoma\r No oligodendrogliomas or oligoastrocytomas\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not\r specified Hematopoietic: WBC at least 3500/mm3 Platelet count at least 130,000/mm3 Hepatic:\r Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2\r times ULN Renal: Creatinine no greater than 0.5 mg/dL Other: Not pregnant or nursing\r Fertile patients must use effective contraception No uncontrolled infection No concurrent\r malignant disease or major medical problem except superficial skin cancers\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 5 years\r since prior chemotherapy Endocrine therapy: Concurrent corticosteroids allowed\r Radiotherapy: At least 5 years since prior radiotherapy Surgery: Not specified\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
15 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nLeflunomide in Treating Patients With Anaplastic Astrocytoma in First Relapse\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die.\r\n\r PURPOSE: Phase II trial to study the effectiveness of leflunomide in treating patients who\r have anaplastic astrocytoma in first relapse.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the median time to progression, median survival, and objective\r response of patients with anaplastic astrocytoma or anaplastic oligoastrocytoma in first\r relapse treated with intravenous leflunomide (SU101). II. Assess the safety of SU101 in these\r patients. III. Describe the health-related quality of life of patients treated with\r intravenous SU101.\r\n\r OUTLINE: This is an open label, multicenter study. Patients receive leflunomide (SU101) IV\r over 6 hours on days 1-4. Patients then receive SU101 IV over 6 hours weekly for 6 weeks\r (beginning between days 8-12). Patients exhibiting complete response, partial response, or\r stable disease may continue on treatment for up to a year or until disease progression or\r unacceptable toxicity occurs. Patients continuing therapy receive SU101 IV over 6 hours every\r week for 7 weeks, followed by 1 week of rest. Quality of life is assessed every 8 weeks and\r at the end of the study. Patients are followed every 8 weeks or until tumor progression.\r\n\r PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically confirmed anaplastic astrocytoma or anaplastic\r oligoastrocytoma in first relapse Recurrence or progression at least 6 months from initial\r diagnosis Must have received maximally feasible surgical resection and fractionated\r external beam radiotherapy Must have received no more than 1 prior systemic cytotoxic\r chemotherapy regimen for initial disease Bidimensionally measurable disease by MRI scan\r (stable dose of corticosteroids for at least 7 days prior to scan)\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life\r expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3\r Platelet count at least 75,000/mm3 Hemoglobin at least 9 g/dL Hepatic: AST no greater than\r 3 times upper limit of normal (ULN) Bilirubin less than 1.5 times ULN Renal: Creatinine no\r greater than 2 mg/dL OR Creatinine clearance at least 40 mL/min Other: Not pregnant or\r nursing Negative pregnancy test Fertile patients must use effective contraception during\r and for 3 months after the study No known allergy to etoposide No other acute or chronic\r medical illness or psychiatric disorder\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior epoetin alfa,\r filgrastim (G-CSF), or sargramostim (GM-CSF) and recovered No concurrent immunotherapy\r Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (2\r weeks since vincristine; 6 weeks since nitrosoureas or mitomycin) and recovered No prior\r leflunomide (SU101) therapy No other concurrent chemotherapy Endocrine therapy: No\r concurrent hormonal therapy (except medroxyprogesterone acetate for appetite stimulation)\r Radiotherapy: See Disease Characteristics No more than 1 prior course of radiotherapy At\r least 8 weeks since prior radiotherapy and recovered No prior interstitial radiotherapy or\r implanted carmustine wafers Prior radiosensitizer(s) concurrent with radiotherapy or used\r as neoadjuvant therapy allowed No concurrent radiotherapy Surgery: See Disease\r Characteristics No more than 2 prior surgical resections At least 1 week since prior\r surgery or biopsy for anaplastic astrocytoma No concurrent surgery (including resection,\r stereotactic surgery, or interstitial implants) Other: At least 4 weeks since prior\r investigational agents No other concurrent investigational agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
16 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nIL-4(38-37)-PE38KDEL Immunotoxin in Treating Patients With Recurrent Malignant Astrocytoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: IL-4(38-37)-PE38KDEL immunotoxin may locate tumor cells and kill them without\r harming normal cells. This may be an effective treatment for recurrent malignant astrocytoma.\r\n\r PURPOSE: Phase I trial to study the effectiveness of IL-4(38-37)-PE38KDEL immunotoxin in\r treating patients who have recurrent malignant astrocytoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the maximum tolerated dose of intratumorally infused\r IL-4(38-37)-PE38KDEL immunotoxin in patients with recurrent malignant astrocytoma. II.\r Determine the safety of this regimen in these patients. III. Determine preliminarily any\r efficacy of this regimen in these patients.\r\n\r OUTLINE: This is a dose escalation, multicenter study. Patients undergo a stereotactic biopsy\r under MR/CT guidance. Catheters are then placed into the tumor under stereotactic guidance.\r The catheter is filled with IL-4(38-37)-PE38KDEL immunotoxin (IL-4 toxin), with infusion\r beginning 24 hours after catheter insertion. The IL-4 toxin is infused over 4 days. The\r catheter is removed 45 minutes after the infusion is completed and a MR scan is performed.\r Cohorts of 3 patients each receive escalating doses of IL-4 toxin until the maximum tolerated\r dose (MTD) is reached. The MTD is defined as the dose preceding the dose at which 2 of 3\r patients experience dose limiting toxicity. Patients are followed every 4 weeks for 16 weeks,\r then every 8 weeks for up to 3 years.\r\n\r PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically proven recurrent glioblastoma or anaplastic\r astrocytoma Stereotactically accessible, enhancing mass no greater than 50 mL total volume\r by MRI No significant mass effect Recent craniotomy allowed No anaplastic oligodendroglioma\r No tumors of the brainstem, cerebellum, or both hemispheres No diffuse subependymal or CSF\r disease If on stable or increasing dose of steroid, must have evidence of increasing\r contrast enhancement by MRI or CT scan Prior external beam radiotherapy required\r\n\r PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life\r expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1500/mm3\r Platelet count greater than 100,000/mm3 Hemoglobin greater than 9.5 g/dL Hepatic: Bilirubin\r less than 2 mg/dL AST and ALT less than 2 times upper limit of normal (ULN) PT/PTT no\r greater than ULN Renal: Creatinine less than 2 mg/dL Other: Not pregnant Negative pregnancy\r test Fertile patients must use effective contraception No systemic diseases to cause\r unacceptable anesthetic/operative risk No active infection requiring treatment No\r unexplained febrile illness\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent blood or platelet transfusions\r Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease\r Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior\r radiotherapy Surgery: See Disease Characteristics Medically able to undergo surgery Other:\r No other concurrent investigational agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\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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17 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nRadiolabeled Monoclonal Antibody in Treating Patients With Glioblastoma Multiforme or Anaplastic Astrocytoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver\r tumor-killing substances to them without harming normal cells. This may be an effective\r treatment for some types of brain tumors.\r\n\r PURPOSE: Phase II trial to study the effectiveness of radiolabeled monoclonal antibody in\r treating patients who have glioblastoma multiforme or anaplastic astrocytoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the median time to disease progression in patients with newly diagnosed\r unresectable glioblastoma multiforme (GBM), recurrent GBM, or recurrent anaplastic\r astrocytoma treated with interstitial iodine I 131 monoclonal antibody TNT-1/B.\r\n\r - Determine the median survival time of these patients treated with this regimen.\r\n\r - Determine the safety of this regimen in terms of neurotoxicity, renal, hepatic,\r hematologic, and biochemical profiles in these patients.\r\n\r - Confirm the maximum tolerated dose of this regimen in these patients.\r\n\r - Optimize the drug delivery of this regimen in these patients.\r\n\r - Assess the response of these patients in terms of MRI measured gadolinium enhanced tumor\r volume and gadolinium enhanced tumor area at 8 and 12 weeks following the last dose of\r study drug.\r\n\r OUTLINE: This is a multicenter study.\r\n\r Patients undergo stereotactic implantation of 2 interstitial catheters into the tumor bed.\r One day later, patients receive iodine I 131 monoclonal antibody TNT-1/B interstitially over\r approximately 24 hours. At selected centers, up to 3 additional groups of 3 patients each\r will receive study drug up to 48 hours. Catheters are removed 1 day after completion of the\r infusion. A gadolinium enhanced MRI is performed during week 8. Patients with partial\r response, minimal response, or stable disease repeat the above treatments during week 9.\r Patients with complete response, progressive disease, or unacceptable toxicity receive no\r additional treatment.\r\n\r Patients are followed every month until disease progression. All patients regardless of\r disease progression or retreatment are followed at 36 weeks.\r\n\r PROJECTED ACCRUAL: A total of 60 patients (20 patients with newly diagnosed unresectable\r glioblastoma multiforme [GBM]; 20 patients with recurrent GBM; and 20 patients with recurrent\r anaplastic astrocytoma) will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed newly diagnosed unresectable glioblastoma multiforme (GBM),\r recurrent GBM, or recurrent anaplastic astrocytoma (AA)\r\n\r - MRI scan documenting gadolinium enhanced tumor volume of at least 5 cm3, but no\r greater than 60 cm^3\r\n\r - Recurrent GBM and AA must be documented by MRI after the most recent treatment\r and before any planned surgical debulking\r\n\r - At least 5 days since prior surgical debulking\r\n\r - No planned resection of newly diagnosed GBM before or during study\r\n\r - No bilateral noncontiguous gadolinium enhancing tumors\r\n\r - No satellite lesions greater than 1.5 cm from anticipated location of interstitial\r catheter tip\r\n\r - No more than 2 satellite lesions\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - Not specified\r\n\r Hematopoietic:\r\n\r - Platelet count at least 100,000/mm^3\r\n\r - Absolute neutrophil count at least 1,500/mm^3\r\n\r - WBC at least 3,000/mm^3\r\n\r Hepatic:\r\n\r - Hepatitis B surface antigen negative\r\n\r - Bilirubin no greater than 2.5 times upper limit of normal (ULN)\r\n\r - SGOT and SGPT no greater than 3 times ULN\r\n\r - Alkaline phosphatase no greater than 3 times ULN\r\n\r - Lactic dehydrogenase no greater than 3 times ULN\r\n\r - Prothrombin time no greater than 1.5 times ULN\r\n\r Renal:\r\n\r - Creatinine clearance at least 50 mL/min\r\n\r Cardiovascular:\r\n\r - No significant unstable cardiovascular disease\r\n\r - No New York Heart Association class III/IV heart disease\r\n\r - No evidence of myocardial infarction within the past 3 months\r\n\r Other:\r\n\r - Not pregnant\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r - Human antichimeric antibody (HACA) titer no greater than 48 ng/mL\r\n\r - No anatomical or physiological considerations that would preclude study participation\r\n\r - No active autoimmune disease, active infection, or traumatic injury requiring\r treatment\r\n\r - HIV negative\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - Not specified\r\n\r Chemotherapy:\r\n\r - At least 4 weeks since prior intravenous chemotherapy or Gliadel wafers\r\n\r Endocrine therapy:\r\n\r - Not specified\r\n\r Radiotherapy:\r\n\r - At least 8 weeks since prior external beam or gamma knife radiotherapy\r\n\r Surgery:\r\n\r - See Disease Characteristics\r\n\r Other:\r\n\r - At least 30 days since prior investigational treatment\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
18 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nIrinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.\r Combining chemotherapy with radiation therapy may kill more tumor cells.\r\n\r PURPOSE: Phase II trial to study the effectiveness of irinotecan followed by radiation\r therapy and temozolomide in treating children who have newly diagnosed brain tumor.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Evaluate the efficacy of adjuvant irinotecan in children with newly diagnosed high grade\r gliomas, brain stem glioma, or high risk grade II astrocytomas in terms of complete and\r partial response rate in patients with postoperative measurable disease, and in terms of\r the rate of freedom from recurrence in patients with no postoperative measurable\r disease.\r\n\r - Determine the 3 year overall and progression free survival rates in this patient\r population when treated with adjuvant irinotecan followed by radiotherapy and\r temozolomide.\r\n\r - Assess the hematopoietic toxicity of temozolomide following local radiotherapy in this\r patient population.\r\n\r OUTLINE: Patients receive postoperative irinotecan IV over 60 minutes daily for 5 days on\r weeks 1-2. Treatment repeats every 3 weeks for 2 courses. Following completion of irinotecan\r and if appropriate, patients may undergo a second surgical resection.\r\n\r Within 2 weeks following completion of chemotherapy or within 4 weeks of following a second\r resection, patients receive image guided external beam radiotherapy 5 days per week for 6\r weeks. Patients with residual tumor less than 3.5 cm in maximal diameter may undergo boost\r radiosurgery.\r\n\r At 4 weeks following completion of radiotherapy, patients receive oral temozolomide for 5\r days. Treatment repeats every 3 weeks for 6 courses.\r\n\r Patients are followed every 3 months for 2 years, then every 4 months for 3 years.\r\n\r PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 5 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed newly diagnosed brain tumors\r\n\r - Grade III or IV disease:\r\n\r - Glioblastoma multiforme\r\n\r - Anaplastic astrocytoma\r\n\r - Anaplastic oligodendroglioma\r\n\r - Anaplastic pleomorphic xanthoastrocytoma\r\n\r - Anaplastic or malignant oligoastrocytoma\r\n\r - Gemistocytic astrocytoma\r\n\r - Malignant glioma\r\n\r - Grade II glial tumors in unfavorable locations (i.e., imaging evidence of\r gliomatosis cerebri and/or bithalamic involvement)\r\n\r - Diffuse pontine gliomas with greater than 2/3 involvement of the pon\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 3 to 21\r\n\r Performance status:\r\n\r - Not specified\r\n\r Life expectancy:\r\n\r - Not specified\r\n\r Hematopoietic:\r\n\r - WBC greater than 2,500/mm^3\r\n\r - Platelet count greater than 100,000/mm^3\r\n\r - Hemoglobin greater than 8.0 g/dL\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 2.5 mg/dL\r\n\r - SGOT/SGPT less than 5 times normal\r\n\r Renal:\r\n\r - Creatinine no greater than 2.0 mg/dL\r\n\r Other:\r\n\r - Not pregnant\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r - HIV negative\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - Not specified\r\n\r Chemotherapy:\r\n\r - No prior chemotherapy\r\n\r Endocrine therapy:\r\n\r - Prior corticosteroids allowed\r\n\r Radiotherapy:\r\n\r - No prior radiotherapy\r\n\r Surgery:\r\n\r - No more than 28 days since prior definitive surgery for brain tumor\r\n\r Other:\r\n\r - Concurrent anticonvulsants allowed\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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19 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nGene Therapy in Treating Patients With Recurrent or Progressive Brain Tumors\n\n**Clinical Trial Summary:**\n\nRATIONALE: Inserting the gene for p53 into a person's brain cells may improve the body's\r ability to fight cancer.\r\n\r PURPOSE: Phase I trial to study the effectiveness of p53 gene therapy with SCH-58500 in\r treating patients who have recurrent, or progressive glioblastoma multiforme, anaplastic\r astrocytoma, or anaplastic mixed glioma that can be removed during surgery.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Estimate the efficiency of tumor cell transduction with adenovirus p53\r delivered stereotactically to patients with recurrent or progressive resectable glioblastoma\r multiforme, anaplastic astrocytoma, or anaplastic mixed glioma. II. Determine the maximum\r tolerated dose of adenovirus p53 delivered stereotactically and with craniotomy in these\r patients. III. Correlate analysis of predelivery tumor specimen p53 gene status with\r postdelivery p53 gene status, clinical status, and tumor staging in these patients treated\r with this regimen. IV. Correlate analysis of postdelivery tumor specimen p53 gene status and\r local tumor immune response with postdelivery clinical status and tumor imaging in these\r patients treated with this regimen.\r\n\r OUTLINE: This is a dose escalation, multicenter study. Patients receive SCH-58500 via\r stereotactic injection into the tumor, followed 24-72 hours later by craniotomy. Patients\r undergo tumor resection, followed by injection of SCH-58500 into the tumor bed during\r craniotomy. Cohorts of 3-6 patients receive escalating doses of SCH-58500 until the maximum\r tolerated dose (MTD) is determined. The MTD is defined as the dose immediately preceding that\r at which 3 of 3-6 patients experience dose limiting toxicity. Patients are followed at day\r 28, then every 2 months for 1 year, and then annually thereafter, until another therapy is\r begun or disease progression is documented.\r\n\r PROJECTED ACCRUAL: A total of 21-42 patients will be accrued for this study over 14-27\r months.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically proven glioblastoma multiforme, anaplastic\r astrocytoma, or anaplastic mixed glioma Progressive or recurrent disease following\r radiotherapy (54-64 Gy) and/or chemotherapy Tumor recurrence must have anatomic\r characteristics that allow safe and reasonable surgical intervention Measurable disease by\r serial MR or CT imaging No Li-Fraumeni syndrome or known germline defect in p53 gene No\r radiographically or surgically proven gliomatosis cerebri No tumors requiring immediate\r excision due to impending neurologic decline\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life\r expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count\r at least 1,000/mm3 Platelet count at least 100,000/mm3 Hematocrit at least 25% Hepatic:\r Bilirubin less than 1.5 mg/dL SGOT and SGPT less than 2.5 times upper limit of normal (ULN)\r PT or PTT no greater than ULN Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular:\r No uncontrolled hypertension No uncontrolled or unstable angina pectoris No uncontrolled\r cardiac dysrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients\r must use effective contraception during and for 6 months after study HIV negative No other\r active malignancy within the past 5 years except curatively treated basal or squamous cell\r skin cancer or carcinoma in situ of the cervix No uncontrolled or serious concurrent\r infection or other serious medical illness that would preclude study therapy No viral\r syndrome diagnosed within 2 weeks prior to study No other underlying medical condition that\r would increase risk of study or obscure interpretation of adverse results No active\r adenoviral infection\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy\r and recovered No concurrent biologic therapy Chemotherapy: See Disease Characteristics No\r more than 1 prior chemotherapy regimen At least 3 weeks since prior chemotherapy (6 weeks\r for nitrosoureas) and recovered No prior interstitial chemotherapy such as Gliadel wafer\r implantation for present brain tumor No concurrent chemotherapy Endocrine therapy: At least\r 3 weeks since prior hormonal therapy and recovered No concurrent hormonal therapy\r Radiotherapy: See Disease Characteristics No prior brachytherapy for present brain tumor At\r least 3 months since other prior radiotherapy and recovered No concurrent radiotherapy\r Surgery: See Disease Characteristics No prior radiosurgery for present brain tumor At least\r 3 weeks since other prior oncologic surgery No other concurrent oncologic surgery Other: No\r other concurrent investigational drugs\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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20 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nTemozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die.\r\n\r PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who\r have recurrent or progressive malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the progression-free survival and response rate of patients with recurrent or\r progressive malignant glioma treated with temozolomide.\r\n\r - Determine whether certain categories of malignant gliomas, such as oligodendroglioma,\r are more sensitive to temozolomide.\r\n\r - Determine the toxicity of this regimen in these patients.\r\n\r OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma\r multiforme [closed to accrual 11/30/01] vs recurrent anaplastic astrocytoma vs recurrent\r anaplastic oligodendroglioma).\r\n\r Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every\r 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.\r\n\r PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically proven recurrent or progressive malignant glioma of one of the\r following types:\r\n\r - Anaplastic oligodendroglioma or oligoastrocytoma\r\n\r - Anaplastic astrocytoma\r\n\r - Glioblastoma multiforme (stratum closed to accrual 11/30/01)\r\n\r - Patients who have failed radiotherapy are eligible\r\n\r - Measurable disease by CT scan or MRI\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 70-100%\r\n\r Life expectancy:\r\n\r - At least 12 weeks\r\n\r Hematopoietic:\r\n\r - Absolute neutrophil count greater than 1,500/mm^3\r\n\r - Platelet count greater than 100,000/mm^3\r\n\r - Hemoglobin greater than 10 g/dL\r\n\r Hepatic:\r\n\r - SGOT or SGPT less than 3 times upper limit of normal (ULN)\r\n\r - Alkaline phosphatase less than 2 times ULN (if greater than 2 times ULN then a gamma\r glutamyl transferase test must be performed)\r\n\r Renal:\r\n\r - BUN less than 1.5 times ULN\r\n\r - Creatinine less than 1.5 times ULN\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective barrier contraception\r\n\r - No other serious concurrent infection or other medical illness that would preclude\r study entry\r\n\r - No frequent vomiting or partial bowel obstruction\r\n\r - HIV negative\r\n\r - No AIDS-related illness\r\n\r - No other concurrent malignancy except carcinoma in situ of the cervix or basal cell\r skin cancer\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - No concurrent epoetin alfa\r\n\r Chemotherapy:\r\n\r - At least 6 weeks since other prior chemotherapy\r\n\r Endocrine therapy:\r\n\r - Not specified\r\n\r Radiotherapy:\r\n\r - See Disease Characteristics\r\n\r - At least 3 months since prior radiotherapy (exceptions allowed for\r recurrent/progressive disease at discretion of primary investigator)\r\n\r Surgery:\r\n\r - Recovered from prior surgery\r\n\r Other:\r\n\r - No other concurrent investigational agents\r\n\r - Concurrent anticonvulsant therapy allowed\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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21 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nRadiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas\n\n**Clinical Trial Summary:**\n\nRATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in\r chemotherapy, such as temozolomide, carmustine, and lomustine, use different ways to stop\r tumor cells from dividing so they stop growing or die. Combining radiation therapy with\r chemotherapy may kill more tumor cells.\r\n\r PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to\r see how well they work compared to radiation therapy and carmustine or lomustine in treating\r patients with anaplastic astrocytoma or mixed gliomas.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Compare the overall survival and time to tumor progression in patients with anaplastic\r astrocytoma or mixed gliomas treated with radiotherapy combined with temozolomide vs\r carmustine or lomustine vs temozolomide and carmustine (arm discontinued as of 8/15/02).\r\n\r - Compare the relative toxic effects of these regimens in these patients.\r\n\r - Correlate molecular analyses with overall survival and time to tumor progression in\r patients treated with these regimens.\r\n\r OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age\r (under 50 vs 50 and over), Karnofsky performance status (60-80% vs 90-100%), and prior\r surgery (biopsy only vs resection).\r\n\r Phase I\r\n\r - Pilot Arms I and II: Prior to initiating the randomization to 1 of 3 treatment arms in\r phase III, Patients are accrued to Arm III regimen to determine tolerability.\r\n\r Phase III\r\n\r - Patients are randomized to 1 of 2 treatment arms (3rd arm was dropped).\r\n\r - Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive\r oral temozolomide on days 1-5 of the first week of radiotherapy. Chemotherapy\r repeats every 4 weeks for a total of 12 courses.\r\n\r - Arm II: Patients undergo radiotherapy as in arm I. Patients receive carmustine IV\r or lomustine IV over 1-2 hours on days 1-3 of the first week of radiotherapy and a\r second course on days 56-58. Chemotherapy repeats every 8 weeks for a total of 6\r courses.\r\n\r - Arm III (dropped, did not open): Patients undergo radiotherapy as in arm I.\r Patients receive carmustine IV or lomustine IV over 3 hours on day 5 and oral\r temozolomide (2 hours after completion of carmustine or lomustine infusion) on days\r 1-5 of the first week of radiotherapy. Combination chemotherapy repeats every 8\r weeks for 6 courses.\r\n\r Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then\r annually thereafter.\r\n\r PROJECTED ACCRUAL: Phase I: 30 patients; Phase III: 454 patients (227 per treatment arm)\r within 4 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically proven unifocal anaplastic astrocytoma or mixed gliomas, including the\r following:\r\n\r - Anaplastic astrocytoma\r\n\r - Mixed oligodendroglial/astrocytic tumors\r\n\r - Oligodendroglial component must be no greater than 25%\r\n\r - No vascular proliferation and necrosis\r\n\r - Increased cellularity, pleomorphism, and nuclear atypia allowed\r\n\r - No tumor predominantly located in the posterior fossa (i.e., brainstem or cerebellum)\r\n\r - Patients with prior biopsy proven low grade astrocytoma who now have anaplastic\r astrocytoma and have had no prior radiotherapy or chemotherapy also eligible\r\n\r - Study therapy must begin within 6 weeks of diagnosis\r\n\r - No spinal cord tumors, spinal drop metastases, or metastases to noncontiguous meninges\r\n\r - Pathologic evidence of local meningeal infiltration by underlying tumor allowed\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - At least 1 year\r\n\r Hematopoietic:\r\n\r - Hemoglobin at least 10 g/dL\r\n\r - Absolute neutrophil count at least 1,500/mm^3\r\n\r - Platelet count at least 150,000/mm^3\r\n\r Hepatic:\r\n\r - Bilirubin less than 2 times upper limit of normal (ULN)\r\n\r - Aspartate aminotransferase (AST) less than 2 times ULN\r\n\r - Alkaline phosphatase less than 2 times ULN\r\n\r Renal:\r\n\r - Blood urea nitrogen no greater than 25 mg/dL\r\n\r - Creatinine less than 1.5 times normal\r\n\r Pulmonary:\r\n\r - No pre-existing lung disease that, in the investigator's opinion, would preclude\r administration of carmustine or lomustine or completion of therapy\r\n\r Other:\r\n\r - No other major medical illness or psychiatric impairment that would preclude study\r compliance\r\n\r - No other malignancy within the past 5 years except nonmelanomatous skin cancer or\r carcinoma in situ of the cervix\r\n\r - No known hypersensitivity to 1 of the components of carmustine, lomustine,\r temozolomide, dacarbazine, or any other nitrosourea\r\n\r - No active infection\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - No prior biologic therapy\r\n\r Chemotherapy:\r\n\r - See Disease Characteristics\r\n\r - No prior chemotherapy\r\n\r Endocrine therapy:\r\n\r - Not specified\r\n\r Radiotherapy:\r\n\r - See Disease Characteristics\r\n\r - No prior radiotherapy to brain or head and neck\r\n\r Surgery:\r\n\r - Not specified\r\n\r Other:\r\n\r - No other concurrent anticancer treatment for anaplastic astrocytoma until a recurrence\r is detected\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPhase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis\n\n**Clinical Trial Summary:**\n\nOBJECTIVES: I. Compare the rate of treatment failure in osteopetrosis patients receiving\r interferon gamma in combination with calcitriol to the rate of treatment failure in patients\r receiving calcitriol alone.\r\n\r II. Compare the number of adverse events or clinical manifestations of disease progression\r occurring in these patients.\r\n\r III. Assess the effects of interferon gamma on hematopoiesis, cranial nerve function, and\r rate of infection in these patients.\n\n**Clinical Trial Detailed Description:**\n\nPROTOCOL OUTLINE: This is a randomized, placebo controlled, open label study. Patients are\r randomized to one of two arms (interferon gamma in combination with calcitriol or calcitriol\r alone).\r\n\r Arm I: Patients receive calcitriol once daily. Interferon gamma is administered by\r subcutaneous injection three times a week.\r\n\r Arm II: Patients receive calcitriol once daily. Patients may continue treatment in the\r absence of toxicity and disease progression. If disease progression is diagnosed in the\r control group, patients will then receive interferon gamma in combination with calcitriol.\r\n\r Patients are followed every 4 weeks.\n\n**Clinical Trial Eligibility Criteria:**\n\nPROTOCOL ENTRY CRITERIA:\r\n\r --Disease Characteristics--\r\n\r - Biopsy and x-ray confirmed primary osteopetrosis\r\n\r - Presence of anemia and/or cranial nerve compression\r\n\r --Prior/Concurrent Therapy--\r\n\r - Biologic therapy: No prior/concurrent bone marrow transplantation No prior interferon\r gamma No other investigational biologic agents\r\n\r - Chemotherapy: No prior/concurrent chemotherapeutic agents for bone marrow\r transplantation\r\n\r - Endocrine therapy: Prior/concurrent corticosteroid as supportive therapy allowed\r\n\r - Radiotherapy: Not specified\r\n\r - Surgery: At least 5 days since major surgery\r\n\r - Other: Prior/concurrent calcitriol as supportive therapy allowed Prior/concurrent\r transfusion as supportive therapy allowed Prior/concurrent dietary therapy allowed\r\n\r --Patient Characteristics--\r\n\r - Age: 2 months to 10 years\r\n\r - Performance status: Not specified\r\n\r - Life expectancy: At least 6 months\r\n\r - Hematopoietic: Not specified\r\n\r - Hepatic: Bilirubin less than 2 mg/dL\r\n\r - Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min\r\n\r - Pulmonary: No uncorrected airway obstruction\r\n\r - Other: No active infection requiring intravenous antibiotics No known seizure disorder\r not related to hypocalcemia No uncorrected hydrocephalus No MRI evidence of cerebral\r atrophy Must maintain or gain body weight No sleep apnea No thrombocytopenia No\r massive splenomegaly\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSU5416 in Treating Patients With Recurrent Astrocytoma or Mixed Glioma That Has Not Responded to Radiation Therapy\n\n**Clinical Trial Summary:**\n\nRATIONALE: SU5416 may stop the growth of astrocytoma or glioma by stopping blood flow to the\r tumor.\r\n\r PURPOSE: Phase I/II trial to study the effectiveness of SU5416 in treating patients who have\r recurrent astrocytoma or mixed glioma that has not responded to previous radiation therapy.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: Phase I:\r\n\r - Determine the maximum tolerated dose of SU5416 in patients with recurrent malignant\r glioma who are, as well as those who are not, taking enzyme-inducing antiepileptic\r drugs.\r\n\r - Determine the toxic effects (safety profile) of this drug in this patient population.\r\n\r - Characterize the pharmacokinetics of this drug in these patients.\r\n\r - Develop exploratory data relative to surrogate endpoints of angiogenic activity in vivo,\r including functional imaging and in vitro assays of endothelial cell inhibition and\r serum angiogenic peptides.\r\n\r Phase II:\r\n\r - Determine the efficacy of SU5416, in terms of 6-month progression-free survival, in\r patients with recurrent high-grade glioma.\r\n\r - Determine, further, the safety profile of the phase II dose of this drug in this patient\r population.\r\n\r - Develop exploratory data relative to surrogate endpoints of angiogenic activity in vivo\r including functional imaging and in vitro assays of endothelial cell inhibition and\r serum angiogenic peptides.\r\n\r OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to\r concurrent enzyme-inducing antiepileptic drugs (no vs yes).\r\n\r Patients receive SU5416 IV on days 1 and 4 weekly for 4 weeks. Courses repeat every 4 weeks\r in the absence of unacceptable toxicity or disease progression.\r\n\r Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose\r (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6\r patients experience dose-limiting toxicity. Once the MTD has been determined, additional\r patients are accrued to the phase II portion of the study. These patients receive SU5416 IV,\r as in the phase I portion, at the appropriate MTD established in phase I.\r\n\r Patients are followed for survival.\r\n\r PROJECTED ACCRUAL: At least 30 patients will be accrued for the phase I dose-escalation\r portion of this study within 10 months. An additional 48 patients (32 with glioblastoma\r multiforme and 16 with anaplastic glioma) will be accrued for the phase II portion of this\r study within 6-8 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically proven supratentorial malignant primary glioma, including:\r\n\r - Glioblastoma multiforme\r\n\r - Anaplastic astrocytoma\r\n\r - Anaplastic oligodendroglioma\r\n\r - Anaplastic mixed oligoastrocytoma\r\n\r - Malignant astrocytoma not otherwise specified\r\n\r - Benign or malignant meningiomas, including brain and spinal meningiomas\r\n\r - Patients with meningiomas are excluded from phase II portion of study\r\n\r - Must have shown unequivocal evidence of tumor recurrence or progression by CT scan or\r MRI\r\n\r - Must have failed prior radiotherapy\r\n\r - Must have prestudy contrast MRI or contrast CT scan of brain on stable steroid dose\r within the past 14 days\r\n\r - Must be on stable (unchanged) dose of steroids for at least 5 days before scans\r\n\r - Phase II:\r\n\r - Must have completed radiotherapy at least 2 months prior to enrollment\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - More than 8 weeks\r\n\r Hematopoietic:\r\n\r - WBC at least 2,300/mm^3\r\n\r - Platelet count at least 100,000/mm^3\r\n\r - Hemoglobin at least 8 g/dL (transfusion allowed)\r\n\r Hepatic:\r\n\r - SGOT less than 2.5 times upper limit of normal\r\n\r - Bilirubin normal\r\n\r - No significant active hepatic disease\r\n\r Renal:\r\n\r - Creatinine less than 1.5 mg/dL OR\r\n\r - Creatinine clearance at least 60 mL/min\r\n\r - No significant active renal disease\r\n\r Cardiovascular:\r\n\r - No uncompensated coronary artery disease on ECG or physical examination\r\n\r - No history of myocardial infarction or severe/unstable angina within the past 6 months\r\n\r - No deep venous or arterial thrombosis within the past 3 months\r\n\r Pulmonary:\r\n\r - No pulmonary embolism within the past 3 months\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Fertile patients must use effective contraception during and for 2 months after study\r\n\r - No other serious concurrent illness\r\n\r - No significant active psychiatric disease\r\n\r - No diabetes mellitus with severe peripheral vascular disease\r\n\r - No other malignancy within the past 3 years except nonmelanoma skin cancer or\r carcinoma in situ of the cervix\r\n\r - No serious active infection\r\n\r - No other concurrent disease that would obscure toxic effects or dangerously alter drug\r metabolism\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - At least 3 weeks since prior biologic therapy (e.g., interferon) and recovered\r\n\r - No concurrent immunotherapy\r\n\r Chemotherapy:\r\n\r - Phase I:\r\n\r - No more than 2 prior chemotherapy regimens for recurrent disease\r\n\r - Phase II:\r\n\r - No more than 1 prior chemotherapy regimen for recurrent disease\r\n\r - At least 2 weeks since prior vincristine\r\n\r - At least 6 weeks since prior nitrosoureas\r\n\r - At least 3 weeks since prior procarbazine\r\n\r - Recovered from prior chemotherapy\r\n\r - No concurrent chemotherapy\r\n\r Endocrine therapy:\r\n\r - See Disease Characteristics\r\n\r - At least 3 weeks since prior endocrine therapy (e.g., tamoxifen) and recovered\r\n\r Radiotherapy:\r\n\r - See Disease Characteristics\r\n\r - No concurrent radiotherapy\r\n\r Surgery:\r\n\r - Recovered from prior surgery\r\n\r - Recent prior resection of recurrent or progressive tumor allowed\r\n\r Other:\r\n\r - No other concurrent investigational agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nCarmustine Plus O6-benzylguanine in Treating Patients With Recurrent or Progressive Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Combining more than one drug may kill more tumor cells.\r\n\r PURPOSE: Phase II trial to study the effectiveness of combining carmustine and\r O6-benzylguanine in treating patients who have recurrent or progressive glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the activity of carmustine and O6-benzylguanine in patients with\r recurrent or progressive glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma\r resistant to nitrosourea. II. Determine the toxic effects of this regimen in these patients.\r\n\r OUTLINE: Patients receive O6-benzylguanine IV over 1 hour, followed 1 hour later by\r carmustine IV over 1 hour on day 1. Treatment repeats every 6 weeks in the absence of disease\r progression or unacceptable toxicity.\r\n\r PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 12-18\r months.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically confirmed recurrent or progressive glioblastoma\r multiforme, anaplastic astrocytoma, or gliosarcoma Resistant to nitrosourea (defined as\r progressive or recurrent disease within 8 weeks of receiving nitrosourea) Measurable\r residual disease by MRI or CT scan\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life\r expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3\r Platelet count at least 100,000/mm3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin\r normal SGOT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater\r than 1.5 mg/dL BUN no greater than 25 mg/dL Pulmonary: DLCO greater than 80% predicted\r Other: Not pregnant or nursing Fertile patients must use effective contraception during and\r for 2 months after study\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease\r Characteristics At least 4 weeks since prior chemotherapy At least 6 weeks since prior\r nitrosourea, procarbazine, or mitomycin and recovered No prior nitrosourea greater than\r 1,200 mg/m2 Endocrine therapy: Concurrent stable dose corticosteroids allowed if on for at\r least two weeks prior to study Radiotherapy: At least 4 weeks since prior radiotherapy\r Surgery: Not specified\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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25 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nCombination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Combining more than one chemotherapy drug may kill more tumor\r cells.\r\n\r PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy following\r radiation therapy in treating patients who have malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the safety and efficacy of extended low-dose temozolomide when combined with\r carmustine after radiotherapy in patients with malignant glioma.\r\n\r - Determine the maximum tolerated dose of this combination in this patient population.\r\n\r - Determine time to progression as measured from baseline gadolinium-enhanced magnetic\r resonance imaging in patients treated with this regimen.\r\n\r OUTLINE: This is a dose-escalation study of temozolomide.\r\n\r Patients receive oral temozolomide once daily on days 1-28 and carmustine IV over 1-3 hours\r beginning within 72 hours after starting temozolomide. Courses repeat every 8 weeks for up to\r 1 year in the absence of unacceptable toxicity or disease progression.\r\n\r Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated\r dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6\r patients experience dose-limiting toxicity.\r\n\r Patients are followed every 2 months.\r\n\r PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1-2 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed malignant glioma\r\n\r - Glioblastoma\r\n\r - Gliosarcoma\r\n\r - High-grade glioma\r\n\r - Anaplastic astrocytoma\r\n\r - Anaplastic mixed oligoastrocytoma\r\n\r - Anaplastic oligodendroglioma\r\n\r - Anaplastic ependymoma\r\n\r - Must have completed radiotherapy\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - More than 3 months\r\n\r Hematopoietic:\r\n\r - Absolute neutrophil count at least 1,500/mm^3\r\n\r - Platelet count at least 100,000/mm^3\r\n\r - Hemoglobin at least 10 g/dL\r\n\r Hepatic:\r\n\r - Bilirubin less than 1.5 times upper limit of normal (ULN)\r\n\r - SGOT/SGPT less than 3 times ULN\r\n\r - Alkaline phosphatase less than 2 times ULN\r\n\r Renal:\r\n\r - BUN less than 1.5 times ULN\r\n\r - Creatinine less than 1.5 times ULN\r\n\r Pulmonary:\r\n\r - Pulmonary function test with diffusion greater than 50 OR\r\n\r - Clearance by the pulmonary service\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r - HIV negative\r\n\r - No AIDS-related illness\r\n\r - No nonmalignant systemic disease that would preclude study\r\n\r - No acute infection requiring IV antibiotics\r\n\r - No psychiatric condition that would preclude study compliance\r\n\r - No frequent vomiting or medical condition that would interfere with oral medication\r intake (e.g., partial bowel obstruction)\r\n\r - No other prior or concurrent malignancy except surgically cured carcinoma in situ of\r the cervix or basal cell or squamous cell skin cancer\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - No prior immunotherapy\r\n\r - No prior biologic therapy\r\n\r Chemotherapy:\r\n\r - No prior chemotherapy\r\n\r Endocrine therapy:\r\n\r - Not specified\r\n\r Radiotherapy:\r\n\r - See Disease Characteristics\r\n\r - At least 2 weeks since prior radiotherapy\r\n\r Surgery:\r\n\r - Not specified\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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26 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nOxaliplatin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme\n\n**Clinical Trial Summary:**\n\nThis phase I/II trial is studying the side effects and best dose of oxaliplatin in treating\r patients with newly diagnosed glioblastoma multiforme. Drugs used in chemotherapy, such as\r oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the\r cells or by stopping them from dividing\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r I. Determine the maximum tolerated dose of oxaliplatin in patients with newly diagnosed\r glioblastoma multiforme who are receiving or not receiving anticonvulsants known to be\r metabolized by P450.\r\n\r II. Determine the dose-limiting toxicity and safety profile of this drug in this patient\r population.\r\n\r III. Assess the pharmacokinetics of this drug on this schedule and determine the effects of\r P450-inducing anticonvulsants on the pharmacokinetics in these patients.\r\n\r IV. Determine the radiographic response rate in patients treated with this drug.\r\n\r V. Determine survival and drug toxicity in these patients.\r\n\r OUTLINE: This is a phase I dose-escalation study of oxaliplatin followed by a phase II study.\r Patients are stratified according to whether concurrent anticonvulsant drugs induce P450 (yes\r vs modest/no or no drugs).\r\n\r Phase I: Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14\r days for a maximum of 6 courses in the absence of unacceptable toxicity or disease\r progression.\r\n\r Cohorts of 3-6 patients (per stratum) receive escalating doses of oxaliplatin until the\r maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at\r which 2 of 6 patients experience dose-limiting toxicity.\r\n\r Phase II: Patients receive oxaliplatin as in phase I at the MTD determined in phase I.\r\n\r Patients are followed at 1 month, every 2 months until disease progression, and then monthly\r thereafter.\r\n\r PROJECTED ACCRUAL: Approximately 24 patients (12 per stratum) will be accrued for the phase I\r part of this study within 8-12 months. A total of 18-35 patients will be accrued for the\r phase II part of this study within 5-12 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histologically confirmed supratentorial grade IV astrocytoma\r\n\r - Glioblastoma multiforme\r\n\r - Subtotal resection or biopsy with measurable and contrast-enhancing disease on the\r postoperative, pretreatment MRI/CT scan\r\n\r - Performance status - Karnofsky 60-100%\r\n\r - Absolute neutrophil count at least 1,500/mm^3\r\n\r - Platelet count at least 100,000/mm^3\r\n\r - Hemoglobin at least 9.0 g/dL\r\n\r - Bilirubin normal\r\n\r - Creatinine normal\r\n\r - Creatinine clearance at least 60 mL/min\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r - No serious concurrent infection or medical illness that would jeopardize ability to\r receive protocol chemotherapy with reasonable safety\r\n\r - No other prior malignancy within the past 5 years except curatively treated carcinoma\r in situ or basal cell skin cancer\r\n\r - No grade 2 or greater pre-existing sensory neuropathy\r\n\r - No history of allergy to platinum compounds or to antiemetics appropriate for\r administration in conjunction with protocol chemotherapy\r\n\r - Mini mental score at least 15\r\n\r - No prior immunotherapy for glioblastoma multiforme\r\n\r - No prior biologic therapy for glioblastoma multiforme, including:\r\n\r - Immunotoxins\r\n\r - Immunoconjugates\r\n\r - Antiangiogenesis compounds\r\n\r - Antisense\r\n\r - Peptide receptor antagonists\r\n\r - Interferons\r\n\r - Interleukins\r\n\r - Tumor infiltrating lymphocytes\r\n\r - Lymphokine activated killer cells\r\n\r - Gene therapy\r\n\r - No concurrent filgrastim (G-CSF)\r\n\r - No prior chemotherapy for glioblastoma multiforme\r\n\r - No prior hormonal therapy for glioblastoma multiforme\r\n\r - Prior glucocorticoid therapy for glioblastoma multiforme allowed\r\n\r - Must be maintained on a stable (lowest required dose) corticosteroid regimen for at\r least 5 days before and during study\r\n\r - No concurrent dexamethasone as an antiemetic\r\n\r - No prior radiotherapy for glioblastoma multiforme\r\n\r - Recovered from immediate postoperative period\r\n\r - At least 10 days since prior anticonvulsant drug that induces hepatic metabolic\r enzymes\r\n\r - No other concurrent investigational agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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27 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nIrinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Combining more than one drug may kill more tumor cells.\r\n\r PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating\r patients who have recurrent primary malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the maximum tolerated dose of irinotecan administered in combination with\r temozolomide in patients with recurrent primary malignant glioma.\r\n\r - Determine the toxicity of this combination therapy in these patients.\r\n\r OUTLINE: This is a dose escalation study of irinotecan. Patients are stratified according to\r concurrent anticonvulsants (Dilantin, Tegretol, or phenobarbital vs other anticonvulsants or\r none).\r\n\r Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and oral temozolomide\r on days 1-5. Treatment continues every 43 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated\r dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6\r patients experience dose limiting toxicities.\r\n\r PROJECTED ACCRUAL: Not specified\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed recurrent primary malignant glioma\r\n\r - Anaplastic astrocytoma\r\n\r - Glioblastoma multiforme\r\n\r - Anaplastic oligodendroglioma\r\n\r - Gliosarcoma\r\n\r - Anaplastic mixed oligoastrocytoma\r\n\r - Measurable disease by MRI or CT\r\n\r - No immediate radiotherapy required\r\n\r - Neurologically stable for at least 2 weeks prior to study\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - Greater than 12 weeks\r\n\r Hematopoietic:\r\n\r - Absolute neutrophil count at least 1,500/mm^3\r\n\r - Platelet count at least 100,000/mm^3\r\n\r - Hemoglobin at least 10 g/dL\r\n\r Hepatic:\r\n\r - Bilirubin less than 1.5 times upper limit of normal (ULN)\r\n\r - SGOT and SGPT less than 2.5 times ULN\r\n\r - Alkaline phosphatase less than 2 times ULN\r\n\r Renal:\r\n\r - Blood urea nitrogen and creatinine less than 1.5 times ULN\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r - HIV negative\r\n\r - No other nonmalignant systemic disease\r\n\r - No acute infection treated with IV antibiotics\r\n\r - No frequent vomiting or other condition that would preclude oral medication\r administration (e.g., partial bowel obstruction)\r\n\r - No other prior malignancies except surgically cured carcinoma in situ of the cervix or\r basal or squamous cell skin cancer\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - No more than 1 prior biologic therapy regimen\r\n\r Chemotherapy:\r\n\r - No more than 1 prior chemotherapy regimen\r\n\r - At least 6 weeks since prior chemotherapy, unless evidence of disease progression\r\n\r - No prior failure of irinotecan or temozolomide\r\n\r Endocrine therapy:\r\n\r - Concurrent corticosteroids allowed\r\n\r Radiotherapy:\r\n\r - See Disease Characteristics\r\n\r - At least 6 weeks since prior radiotherapy, unless evidence of disease progression\r\n\r Surgery:\r\n\r - At least 3 weeks since prior surgery, unless evidence of disease progression, and\r recovered\r\n\r Other:\r\n\r - No concurrent immunosuppressive agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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28 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nTemozolomide Plus Lomustine Followed by Radiation Therapy in Treating Patients With High-Grade Malignant Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.\r Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.\r\n\r PURPOSE: Phase I trial to study the effectiveness of temozolomide plus lomustine followed by\r radiation therapy in treating patients who have high-grade malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the maximum tolerated dose of temozolomide when administered with lomustine in\r patients with high-grade malignant gliomas.\r\n\r - Determine the dose-limiting toxic effects of this regimen in these patients.\r\n\r - Evaluate the feasibility of radiotherapy after this treatment regimen in this patient\r population.\r\n\r - Evaluate the radiographic responses in patients treated with this regimen.\r\n\r OUTLINE: This is a multicenter, dose-escalation study of temozolomide.\r\n\r Patients receive oral temozolomide on days 1-5 and oral lomustine on day 1. Treatment\r continues every 28 days, if blood counts have recovered, for 2 courses in the absence of\r disease progression or unacceptable toxicity. Patients then undergo radiotherapy on days 1-5\r weekly for 6 weeks. Patients continue the same chemotherapy regimen for up to 6 more courses\r beginning 4 weeks after completion of radiotherapy.\r\n\r Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated\r dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2\r of 6 patients experience dose-limiting toxicity.\r\n\r Patients are followed for survival.\r\n\r PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed high-grade malignant glioma of one of the following subtypes:\r\n\r - Glioblastoma\r\n\r - Anaplastic astrocytoma\r\n\r - Anaplastic oligoastrocytoma\r\n\r - Gliomatosis cerebri\r\n\r - No disseminated disease or primary spinal cord malignancies\r\n\r - Measurable intracranial residual disease by MRI\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 3 and over\r\n\r - Under 22 at time of diagnosis\r\n\r Performance status:\r\n\r - Karnofsky 50-100% if over 10 years of age\r\n\r - Lansky 50-100% if 10 years of age or under\r\n\r Life expectancy:\r\n\r - At least 8 weeks\r\n\r Hematopoietic:\r\n\r - Absolute neutrophil count at least 1,000/mm^3\r\n\r - Platelet count at least 100,000/mm^3 (transfusion independent)\r\n\r - Hemoglobin at least 8.0 g/dL (RBC transfusions allowed)\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 1.5 times normal for age\r\n\r - SGPT no greater than 2.5 times normal for age\r\n\r - Albumin at least 2 g/dL\r\n\r Renal:\r\n\r - Creatinine no greater than 1.5 times normal for age OR\r\n\r - Creatinine clearance or radioisotope glomerular filtration rate at least lower limit\r of normal for age\r\n\r Pulmonary:\r\n\r - No dyspnea at rest\r\n\r - No exercise intolerance\r\n\r - Pulse oximetry at least 94%\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r - No uncontrolled infection\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - No prior biologic therapy\r\n\r - No concurrent prophylactic hematopoietic growth factors\r\n\r Chemotherapy:\r\n\r - No prior chemotherapy\r\n\r Endocrine therapy:\r\n\r - Prior corticosteroid therapy allowed\r\n\r - No concurrent corticosteroids as antiemetic\r\n\r Radiotherapy:\r\n\r - No prior radiotherapy\r\n\r Surgery:\r\n\r - No more than 31 days since prior maximal neurosurgical procedure\r\n\r Other:\r\n\r - No concurrent phenobarbital or cimetidine\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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29 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nFenretinide in Treating Patients With Recurrent Malignant Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die.\r\n\r PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who\r have recurrent malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the efficacy of fenretinide as assessed by 6-month progression- free\r survival in patients with recurrent malignant glioma. II. Determine the rate of measurable\r clinical response, time to progression, and overall survival of patients treated with this\r drug. III. Determine the unexpected toxicity of this drug in these patients.\r\n\r OUTLINE: This is a multicenter study. Patients are stratified according to disease type\r (glioblastoma multiforme (closed to accrual as of 05/31/2001) and gliosarcoma (closed to\r accrual as of 05/31/2001) vs anaplastic astrocytoma, anaplastic oligodendroglioma, and mixed\r malignant glioma). Patients receive oral fenretinide twice daily during weeks 1 and 4.\r Treatment repeats every 6 weeks in the absence of disease progression or unacceptable\r toxicity. Quality of life is assessed at baseline and then before each course of\r chemotherapy. Patients are followed every 3 months.\r\n\r PROJECTED ACCRUAL: A total of 41-85 patients (21-45 with anaplastic astrocytoma, anaplastic\r oligodendroglioma, and mixed malignant glioma and 20-40 with glioblastoma multiforme (closed\r to accrual as of 05/31/2001) and gliosarcoma (closed to accrual as of 05/31/2001)) will be\r accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically confirmed supratentorial malignant primary glioma\r Glioblastoma multiforme (closed to accrual as of 05/31/2001) Gliosarcoma (closed to accrual\r as of 05/31/2001) Anaplastic astrocytoma Anaplastic oligodendroglioma Mixed malignant\r gliomas Original histological diagnosis of low-grade glioma allowed if a subsequent\r histological diagnosis of malignant glioma is confirmed Prior treatment for no more than 2\r prior relapses allowed Disease progression documented by at least 2 pre-study brain scans\r Recent prior tumor resection of recurrent or progressive tumor allowed if recovered from\r the effects of prior surgery\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life\r expectancy: More than 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3\r Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (may be transfusion\r dependent) Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) SGOT less than\r 2 times ULN Renal: Creatinine less than 1.5 mg/dL Creatinine clearance at least 60 mL/min\r Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective\r barrier contraception during and for at least 2 months after study Able to swallow capsules\r No active infection No disease or other serious concurrent medical illness that would\r preclude study\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior interferon At least\r 1 week since prior thalidomide Chemotherapy: Recovered from prior chemotherapy At least 4\r weeks since prior cytotoxic therapy (2 weeks for vincristine, 3 weeks for procarbazine, or\r 6 weeks for nitrosoureas) Endocrine therapy: At least 1 week since prior tamoxifen Prior\r steroids allowed if on stable or decreasing dose for at least 5-7 days before baseline MRI\r If steroid dose is increased between date of baseline MRI and initiation of study drug, a\r new baseline MRI is required Radiotherapy: Not specified Surgery: See Disease\r Characteristics No concurrent surgery Other: At least 1 week since any prior noncytotoxic\r agents (e.g., isotretinoin) No other concurrent anticancer therapy, including other\r investigational drugs\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
30 |
[
{
"role": "system",
"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 diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nCarboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Colony-stimulating factors such as filgrastim may increase the\r number of immune cells found in bone marrow or peripheral blood and may help a person's\r immune system recover from the side effects of chemotherapy.\r\n\r PURPOSE: Phase II trial to study the effectiveness of combining carboplatin, temozolomide,\r and filgrastim in treating patients who have newly diagnosed or recurrent high-grade glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the response rate in patients with newly diagnosed high-grade glioma treated\r with temozolomide, carboplatin, and filgrastim (G-CSF).\r\n\r - Determine the toxicity of this treatment regimen in these patients.\r\n\r - Determine the rate of tumor progression in patients treated with this regimen.\r\n\r OUTLINE: This is a multicenter study. Patients are stratified according to disease category\r (glioblastoma multiforme vs anaplastic astrocytoma vs several other high-grade mixed\r gliomas).\r\n\r Patients receive carboplatin IV over 4 hours on days 1-2; oral temozolomide every 12 hours on\r days 1-5; and filgrastim (G-CSF) subcutaneously or IV daily starting no earlier than day 7\r and continuing until blood counts recover. Treatment repeats every 28 days for at least 4\r courses in the absence of disease progression or unacceptable toxicity.\r\n\r PROJECTED ACCRUAL: A total of 102-222 (17-37 per each of 6 strata) will be accrued for this\r study within 4 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed newly diagnosed glioblastoma multiforme or anaplastic\r astrocytoma\r\n\r - Residual tumor on postoperative MRI\r\n\r - Bidimensionally measurable disease\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - Under 65\r\n\r Performance status:\r\n\r - Karnofsky or Lansky 70-100% OR\r\n\r - ECOG 0-2\r\n\r Life expectancy:\r\n\r - Not specified\r\n\r Hematopoietic:\r\n\r - Absolute neutrophil count at least 1,000/mm^3\r\n\r - Hemoglobin at least 8 g/dL (transfusion allowed)\r\n\r - Platelet count greater than 100,000/mm^3\r\n\r Hepatic:\r\n\r - Bilirubin less than 1.5 times upper limit of normal (ULN)\r\n\r - SGPT no greater than 3 times ULN\r\n\r Renal:\r\n\r - Age 5 years and under: Creatinine less than 1.2 mg/dL\r\n\r - Age over 5 to 10 years: Creatinine less than 1.5 mg/dL\r\n\r - Age over 10 to 15 years: Creatinine less than 1.8 mg/dL\r\n\r - Age over 15 years: Creatinine less than 2.4 mg/dL\r\n\r Cardiovascular:\r\n\r - No myocardial infarction within the past 6 months\r\n\r Other:\r\n\r - No other concurrent serious medical condition that would preclude study\r\n\r - Able to tolerate oral medications\r\n\r - No prior malignancy for which patient received prior chemotherapy or spinal\r irradiation\r\n\r - No history of severe allergic reaction to platinum-containing compounds\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - At least 72 hours since prior filgrastim (G-CSF)\r\n\r Chemotherapy:\r\n\r - No prior chemotherapy\r\n\r - No other concurrent chemotherapy\r\n\r Endocrine therapy:\r\n\r - Concurrent steroids for tumor-related cerebral edema allowed\r\n\r - No concurrent corticosteroids for solely antiemetic purposes\r\n\r Radiotherapy:\r\n\r - No prior or concurrent radiotherapy\r\n\r Surgery:\r\n\r - Recovered from prior surgery\r\n\r - No concurrent surgery\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
| Links | |
|---|---|
| Homepage: | Github.io |
| Paper: | 2021 / 2022 / 2023 |
| Contact (Original Authors): | - |
| Contact (Curator): | Artur Guimarães ([email protected]) |
This track focused on matching patients to relevant clinical trials.
{
"query_id":"1",
"disease":"glaucoma",
"text":"definitive diagnosis: primary open angle glaucoma\nvisual field: moderate field damage\nvisual acuity: 0.3\nprior cataract surgery: no\nprior LASIK surgery: no\ncomorbid ocular diseases: corneal edema",
"doc_id":"NCT00000119",
"relevance": "not relevant"
}
TO:DO
TO:DO
Thanks to araag2 for adding this dataset.