{
"info": {
"nct_id": "NCT00002894",
"official_title": "A RANDOMISED TRIAL OF PACLITAXEL (TAXOL) IN COMBINATION WITH PLATINUM CHEMOTHERAPY VS. CONVENTIONAL PLATINUM-BASED CHEMOTHERAPY IN THE TREATMENT OF WOMEN WITH RELAPSED OVARIAN CANCER",
"inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Ovarian epithelial cancer or serous peritoneal carcinoma that has relapsed after prior chemotherapy\n\n * Progression-free interval (from end of last treatment) of at least 6 months\n* Measurable disease not required\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Not specified\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Bilirubin less than 2 times normal\n\nRenal:\n\n* Not specified\n\nOther:\n\n* No sepsis\n* No contraindication to chemotherapy\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* See Disease Characteristics\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified"
},
"inclusion_lines": [
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
}
]
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"line": "DISEASE CHARACTERISTICS:",
"criterions": [
{
"exact_snippets": "DISEASE CHARACTERISTICS",
"criterion": "disease characteristics",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "* Ovarian epithelial cancer or serous peritoneal carcinoma that has relapsed after prior chemotherapy",
"criterions": [
{
"exact_snippets": "Ovarian epithelial cancer",
"criterion": "ovarian epithelial cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "serous peritoneal carcinoma",
"criterion": "serous peritoneal carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "has relapsed after prior chemotherapy",
"criterion": "relapse after prior chemotherapy",
"requirements": [
{
"requirement_type": "occurrence",
"expected_value": true
}
]
}
]
},
{
"line": "* Progression-free interval (from end of last treatment) of at least 6 months",
"criterions": [
{
"exact_snippets": "Progression-free interval (from end of last treatment) of at least 6 months",
"criterion": "progression-free interval",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
]
}
]
},
{
"line": "* Measurable disease not required",
"criterions": [
{
"exact_snippets": "Measurable disease not required",
"criterion": "measurable disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "Age:",
"criterions": [
{
"exact_snippets": "Age:",
"criterion": "age",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "Performance status:",
"criterions": [
{
"exact_snippets": "Performance status:",
"criterion": "performance status",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "Life expectancy:",
"criterions": [
{
"exact_snippets": "Life expectancy",
"criterion": "life expectancy",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "Hematopoietic:",
"criterions": [
{
"exact_snippets": "Hematopoietic:",
"criterion": "hematopoietic system",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "Hepatic:",
"criterions": [
{
"exact_snippets": "Hepatic:",
"criterion": "hepatic function",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "* Bilirubin less than 2 times normal",
"criterions": [
{
"exact_snippets": "Bilirubin less than 2 times normal",
"criterion": "bilirubin level",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "times normal"
}
}
]
}
]
},
{
"line": "Renal:",
"criterions": [
{
"exact_snippets": "Renal:",
"criterion": "renal function",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "* No sepsis",
"criterions": [
{
"exact_snippets": "No sepsis",
"criterion": "sepsis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No contraindication to chemotherapy",
"criterions": [
{
"exact_snippets": "No contraindication to chemotherapy",
"criterion": "contraindication to chemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "PRIOR CONCURRENT THERAPY:",
"criterions": [
{
"exact_snippets": "PRIOR CONCURRENT THERAPY",
"criterion": "prior concurrent therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Biologic therapy",
"criterions": [
{
"exact_snippets": "Biologic therapy",
"criterion": "biologic therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Chemotherapy",
"criterions": [
{
"exact_snippets": "Chemotherapy",
"criterion": "chemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* See Disease Characteristics",
"criterions": [
{
"exact_snippets": "Disease Characteristics",
"criterion": "disease characteristics",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "refer to disease characteristics section"
}
]
}
]
},
{
"line": "Endocrine therapy",
"criterions": [
{
"exact_snippets": "Endocrine therapy",
"criterion": "endocrine therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Radiotherapy",
"criterions": [
{
"exact_snippets": "Radiotherapy",
"criterion": "radiotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Surgery",
"criterions": [
{
"exact_snippets": "Surgery",
"criterion": "surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"line": "PATIENT CHARACTERISTICS:",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "Other:",
"criterions": [
{
"exact_snippets": "Tissue from tumor must be available",
"criterion": "tumor tissue",
"requirements": [
{
"requirement_type": "availability",
"expected_value": true
}
]
},
{
"exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
"criterion": "tumor tissue",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "cm"
}
}
]
}
]
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
}
]
}