{
"info": {
"nct_id": "NCT00043082",
"official_title": "A Phase III Study of Liposomal Doxorubicin Plus Carboplatin Versus Carboplatin in Platinum-Sensitive Patients With Recurrent Epithelial Ovarian and Peritoneal Carcinoma After Failure of Initial Platinum-Based Chemotherapy",
"inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed ovarian epithelial carcinoma\n\n * Stage III or IV disease at time of initial staging laparotomy\n* Primary peritoneal and mixed Mullerian tumors allowed\n* No borderline ovarian tumors\n* Disease progression or recurrence after a progression-free and platinum-free interval of 6-24 months after completion of first-line platinum-based chemotherapy (either single agent or combination therapy)\n* Disease progression or recurrence based solely on CA 125 elevation allowed, provided that one of the following is true:\n\n * Prior baseline CA 125 greater than 35 U/mL and subsequent normalization of no greater than 35 U/mL must have CA 125 greater than 2 times upper limit of normal (ULN) on 2 occasions at least 1 week apart\n * Prior baseline CA 125 greater than 35 U/mL that never normalized must have CA 125 greater than 2 times the nadir value on 2 occasions at least 1 week apart\n * Prior normal baseline CA 125 (no greater than 35 U/mL) must show CA 125 greater than 2 times ULN on 2 occasions at least 1 week apart\n* No known brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Not specified\n\nPerformance status\n\n* Zubrod 0-1\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute neutrophil count at least 1,500/mm^3\n* Platelet count at least 100,000/mm^3\n* Hemoglobin at least 10 g/dL\n\nHepatic\n\n* SGOT and/or SGPT no greater than 2 times upper limit of normal (ULN)\n* Alkaline phosphatase no greater than 2 times ULN\n* Bilirubin no greater than ULN\n\nRenal\n\n* Creatinine no greater than 1.9 mg/dL\n\nCardiovascular\n\n* No New York Heart Association class II-IV cardiac disease\n* No clinical evidence of congestive heart failure\n* Ejection fraction greater than 50% by MUGA or 2-dimensional echocardiogram\n\nOther\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or incidental carcinoid cancer\n* No evidence of active or uncontrolled infection\n* No severe gastrointestinal symptoms (i.e., partial obstruction) and/or gastrointestinal bleeding or diarrhea\n* No greater than grade 1 preexisting sensory neuropathy\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* At least 28 days since prior biologic consolidation therapy\n* No concurrent immunotherapy\n\nChemotherapy\n\n* See Disease Characteristics\n* At least 28 days since prior non-platinum-containing consolidation chemotherapy\n* No prior pegylated doxorubicin HCl liposome\n* No prior cumulative anthracycline (e.g., doxorubicin, daunorubicin, epirubicin) dose in excess of 240 mg/m^2\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* No concurrent hormonal therapy\n\nRadiotherapy\n\n* No prior abdominopelvic irradiation\n* No concurrent radiotherapy\n\nSurgery\n\n* See Disease Characteristics\n* At least 28 days since prior surgical debulking for disease progression or recurrence and recovered\n* No concurrent surgery\n\nOther\n\n* No other prior treatment during the 6-24 month progression-free and platinum-free interval except up to 12 courses of consolidation therapy\n* No other concurrent anticancer therapy"
},
"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"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 120 Years",
"criterions": [
{
"exact_snippets": "maximum age of 120 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 120,
"unit": "Years"
}
}
]
}
]
}
],
"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": "* Histologically confirmed ovarian epithelial carcinoma",
"criterions": [
{
"exact_snippets": "Histologically confirmed ovarian epithelial carcinoma",
"criterion": "ovarian epithelial carcinoma",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
]
}
]
},
{
"line": "* Stage III or IV disease at time of initial staging laparotomy",
"criterions": [
{
"exact_snippets": "Stage III or IV disease",
"criterion": "disease stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"III",
"IV"
]
}
]
},
{
"exact_snippets": "initial staging laparotomy",
"criterion": "initial staging laparotomy",
"requirements": [
{
"requirement_type": "procedure",
"expected_value": "laparotomy"
}
]
}
]
},
{
"line": "* Primary peritoneal and mixed Mullerian tumors allowed",
"criterions": [
{
"exact_snippets": "Primary peritoneal ... allowed",
"criterion": "primary peritoneal tumors",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "mixed Mullerian tumors allowed",
"criterion": "mixed Mullerian tumors",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* No borderline ovarian tumors",
"criterions": [
{
"exact_snippets": "No borderline ovarian tumors",
"criterion": "borderline ovarian tumors",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Disease progression or recurrence after a progression-free and platinum-free interval of 6-24 months after completion of first-line platinum-based chemotherapy (either single agent or combination therapy)",
"criterions": [
{
"exact_snippets": "Disease progression or recurrence",
"criterion": "disease progression or recurrence",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "progression-free and platinum-free interval of 6-24 months",
"criterion": "progression-free and platinum-free interval",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 6,
"unit": "months"
},
{
"operator": "<=",
"value": 24,
"unit": "months"
}
]
}
}
]
},
{
"exact_snippets": "completion of first-line platinum-based chemotherapy",
"criterion": "completion of first-line platinum-based chemotherapy",
"requirements": [
{
"requirement_type": "completion",
"expected_value": true
}
]
}
]
},
{
"line": "* Disease progression or recurrence based solely on CA 125 elevation allowed, provided that one of the following is true:",
"criterions": [
{
"exact_snippets": "Disease progression or recurrence based solely on CA 125 elevation",
"criterion": "disease progression or recurrence",
"requirements": [
{
"requirement_type": "basis",
"expected_value": "CA 125 elevation"
}
]
}
]
},
{
"line": "* Prior baseline CA 125 greater than 35 U/mL and subsequent normalization of no greater than 35 U/mL must have CA 125 greater than 2 times upper limit of normal (ULN) on 2 occasions at least 1 week apart",
"criterions": [
{
"exact_snippets": "Prior baseline CA 125 greater than 35 U/mL",
"criterion": "baseline CA 125",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 35,
"unit": "U/mL"
}
}
]
},
{
"exact_snippets": "subsequent normalization of no greater than 35 U/mL",
"criterion": "subsequent CA 125 normalization",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 35,
"unit": "U/mL"
}
}
]
},
{
"exact_snippets": "CA 125 greater than 2 times upper limit of normal (ULN) on 2 occasions at least 1 week apart",
"criterion": "CA 125 level",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "times ULN"
}
},
{
"requirement_type": "frequency",
"expected_value": "on 2 occasions at least 1 week apart"
}
]
}
]
},
{
"line": "* Prior baseline CA 125 greater than 35 U/mL that never normalized must have CA 125 greater than 2 times the nadir value on 2 occasions at least 1 week apart",
"criterions": [
{
"exact_snippets": "Prior baseline CA 125 greater than 35 U/mL",
"criterion": "baseline CA 125",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 35,
"unit": "U/mL"
}
}
]
},
{
"exact_snippets": "CA 125 greater than 2 times the nadir value on 2 occasions at least 1 week apart",
"criterion": "CA 125",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "times the nadir value"
}
},
{
"requirement_type": "frequency",
"expected_value": "on 2 occasions at least 1 week apart"
}
]
}
]
},
{
"line": "* Prior normal baseline CA 125 (no greater than 35 U/mL) must show CA 125 greater than 2 times ULN on 2 occasions at least 1 week apart",
"criterions": [
{
"exact_snippets": "Prior normal baseline CA 125 (no greater than 35 U/mL)",
"criterion": "baseline CA 125",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 35,
"unit": "U/mL"
}
}
]
},
{
"exact_snippets": "CA 125 greater than 2 times ULN on 2 occasions at least 1 week apart",
"criterion": "CA 125",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "times ULN"
}
},
{
"requirement_type": "frequency",
"expected_value": "on 2 occasions at least 1 week apart"
}
]
}
]
},
{
"line": "* No known brain metastases",
"criterions": [
{
"exact_snippets": "No known brain metastases",
"criterion": "brain metastases",
"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": "* Zubrod 0-1",
"criterions": [
{
"exact_snippets": "Zubrod 0-1",
"criterion": "Zubrod performance status",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "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": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Absolute neutrophil count at least 1,500/mm^3",
"criterions": [
{
"exact_snippets": "Absolute neutrophil count at least 1,500/mm^3",
"criterion": "absolute neutrophil count",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm^3"
}
}
]
}
]
},
{
"line": "* Platelet count at least 100,000/mm^3",
"criterions": [
{
"exact_snippets": "Platelet count at least 100,000/mm^3",
"criterion": "platelet count",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm^3"
}
}
]
}
]
},
{
"line": "* Hemoglobin at least 10 g/dL",
"criterions": [
{
"exact_snippets": "Hemoglobin at least 10 g/dL",
"criterion": "hemoglobin",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "g/dL"
}
}
]
}
]
},
{
"line": "Hepatic",
"criterions": [
{
"exact_snippets": "Hepatic",
"criterion": "hepatic function",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* SGOT and/or SGPT no greater than 2 times upper limit of normal (ULN)",
"criterions": [
{
"exact_snippets": "SGOT and/or SGPT no greater than 2 times upper limit of normal (ULN)",
"criterion": "SGOT",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "times ULN"
}
}
]
},
{
"exact_snippets": "SGOT and/or SGPT no greater than 2 times upper limit of normal (ULN)",
"criterion": "SGPT",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "times ULN"
}
}
]
}
]
},
{
"line": "* Alkaline phosphatase no greater than 2 times ULN",
"criterions": [
{
"exact_snippets": "Alkaline phosphatase no greater than 2 times ULN",
"criterion": "alkaline phosphatase",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "times ULN"
}
}
]
}
]
},
{
"line": "* Bilirubin no greater than ULN",
"criterions": [
{
"exact_snippets": "Bilirubin no greater than ULN",
"criterion": "bilirubin level",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "ULN"
}
}
]
}
]
},
{
"line": "Renal",
"criterions": [
{
"exact_snippets": "Renal",
"criterion": "renal function",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "* Creatinine no greater than 1.9 mg/dL",
"criterions": [
{
"exact_snippets": "Creatinine no greater than 1.9 mg/dL",
"criterion": "creatinine level",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.9,
"unit": "mg/dL"
}
}
]
}
]
},
{
"line": "Cardiovascular",
"criterions": [
{
"exact_snippets": "Cardiovascular",
"criterion": "cardiovascular condition",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* No New York Heart Association class II-IV cardiac disease",
"criterions": [
{
"exact_snippets": "No New York Heart Association class II-IV cardiac disease",
"criterion": "New York Heart Association cardiac disease",
"requirements": [
{
"requirement_type": "class",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 2,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "* No clinical evidence of congestive heart failure",
"criterions": [
{
"exact_snippets": "No clinical evidence of congestive heart failure",
"criterion": "congestive heart failure",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Ejection fraction greater than 50% by MUGA or 2-dimensional echocardiogram",
"criterions": [
{
"exact_snippets": "Ejection fraction greater than 50%",
"criterion": "ejection fraction",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 50,
"unit": "%"
}
}
]
}
]
},
{
"line": "* Fertile patients must use effective contraception",
"criterions": [
{
"exact_snippets": "Fertile patients",
"criterion": "fertility",
"requirements": [
{
"requirement_type": "status",
"expected_value": "fertile"
}
]
},
{
"exact_snippets": "must use effective contraception",
"criterion": "contraception use",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": true
}
]
}
]
},
{
"line": "* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or incidental carcinoid cancer",
"criterions": [
{
"exact_snippets": "No other malignancy within the past 5 years",
"criterion": "other malignancy",
"requirements": [
{
"requirement_type": "time since last occurrence",
"expected_value": {
"operator": ">=",
"value": 5,
"unit": "years"
}
},
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "except adequately treated basal cell or squamous cell skin cancer",
"criterion": "adequately treated basal cell or squamous cell skin cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "except ... carcinoma in situ of the cervix",
"criterion": "carcinoma in situ of the cervix",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "except ... incidental carcinoid cancer",
"criterion": "incidental carcinoid cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* No evidence of active or uncontrolled infection",
"criterions": [
{
"exact_snippets": "No evidence of active or uncontrolled infection",
"criterion": "infection",
"requirements": [
{
"requirement_type": "status",
"expected_value": [
"not active",
"controlled"
]
}
]
}
]
},
{
"line": "* No severe gastrointestinal symptoms (i.e., partial obstruction) and/or gastrointestinal bleeding or diarrhea",
"criterions": [
{
"exact_snippets": "No severe gastrointestinal symptoms (i.e., partial obstruction)",
"criterion": "gastrointestinal symptoms",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "not severe"
},
{
"requirement_type": "type",
"expected_value": "partial obstruction"
}
]
},
{
"exact_snippets": "No severe gastrointestinal symptoms ... gastrointestinal bleeding",
"criterion": "gastrointestinal bleeding",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No severe gastrointestinal symptoms ... diarrhea",
"criterion": "diarrhea",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No greater than grade 1 preexisting sensory neuropathy",
"criterions": [
{
"exact_snippets": "No greater than grade 1 preexisting sensory neuropathy",
"criterion": "preexisting sensory neuropathy",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "grade"
}
}
]
}
]
},
{
"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": "* At least 28 days since prior biologic consolidation therapy",
"criterions": [
{
"exact_snippets": "At least 28 days since prior biologic consolidation therapy",
"criterion": "time since prior biologic consolidation therapy",
"requirements": [
{
"requirement_type": "time since",
"expected_value": {
"operator": ">=",
"value": 28,
"unit": "days"
}
}
]
}
]
},
{
"line": "* No concurrent immunotherapy",
"criterions": [
{
"exact_snippets": "No concurrent immunotherapy",
"criterion": "immunotherapy",
"requirements": [
{
"requirement_type": "concurrent use",
"expected_value": false
}
]
}
]
},
{
"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": "see disease characteristics section"
}
]
}
]
},
{
"line": "* At least 28 days since prior non-platinum-containing consolidation chemotherapy",
"criterions": [
{
"exact_snippets": "At least 28 days since prior non-platinum-containing consolidation chemotherapy",
"criterion": "time since prior non-platinum-containing consolidation chemotherapy",
"requirements": [
{
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">=",
"value": 28,
"unit": "days"
}
}
]
}
]
},
{
"line": "* No prior pegylated doxorubicin HCl liposome",
"criterions": [
{
"exact_snippets": "No prior pegylated doxorubicin HCl liposome",
"criterion": "pegylated doxorubicin HCl liposome",
"requirements": [
{
"requirement_type": "prior treatment",
"expected_value": false
}
]
}
]
},
{
"line": "* No prior cumulative anthracycline (e.g., doxorubicin, daunorubicin, epirubicin) dose in excess of 240 mg/m^2",
"criterions": [
{
"exact_snippets": "No prior cumulative anthracycline (e.g., doxorubicin, daunorubicin, epirubicin) dose in excess of 240 mg/m^2",
"criterion": "cumulative anthracycline dose",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 240,
"unit": "mg/m^2"
}
}
]
}
]
},
{
"line": "* No other concurrent chemotherapy",
"criterions": [
{
"exact_snippets": "No other concurrent chemotherapy",
"criterion": "concurrent chemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "Endocrine therapy",
"criterions": [
{
"exact_snippets": "Endocrine therapy",
"criterion": "endocrine therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* No concurrent hormonal therapy",
"criterions": [
{
"exact_snippets": "No concurrent hormonal therapy",
"criterion": "hormonal therapy",
"requirements": [
{
"requirement_type": "concurrent use",
"expected_value": false
}
]
}
]
},
{
"line": "Radiotherapy",
"criterions": [
{
"exact_snippets": "Radiotherapy",
"criterion": "radiotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* No prior abdominopelvic irradiation",
"criterions": [
{
"exact_snippets": "No prior abdominopelvic irradiation",
"criterion": "abdominopelvic irradiation",
"requirements": [
{
"requirement_type": "prior treatment",
"expected_value": false
}
]
}
]
},
{
"line": "* No concurrent radiotherapy",
"criterions": [
{
"exact_snippets": "No concurrent radiotherapy",
"criterion": "concurrent radiotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "Surgery",
"criterions": [
{
"exact_snippets": "Surgery",
"criterion": "surgery",
"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": "see disease characteristics"
}
]
}
]
},
{
"line": "* At least 28 days since prior surgical debulking for disease progression or recurrence and recovered",
"criterions": [
{
"exact_snippets": "At least 28 days since prior surgical debulking",
"criterion": "time since surgical debulking",
"requirements": [
{
"requirement_type": "time elapsed",
"expected_value": {
"operator": ">=",
"value": 28,
"unit": "days"
}
}
]
},
{
"exact_snippets": "recovered",
"criterion": "recovery from surgical debulking",
"requirements": [
{
"requirement_type": "recovery status",
"expected_value": true
}
]
}
]
},
{
"line": "* No concurrent surgery",
"criterions": [
{
"exact_snippets": "No concurrent surgery",
"criterion": "concurrent surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No other prior treatment during the 6-24 month progression-free and platinum-free interval except up to 12 courses of consolidation therapy",
"criterions": [
{
"exact_snippets": "No other prior treatment during the 6-24 month progression-free and platinum-free interval",
"criterion": "prior treatment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "up to 12 courses of consolidation therapy",
"criterion": "consolidation therapy",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 12,
"unit": "courses"
}
}
]
}
]
},
{
"line": "* No other concurrent anticancer therapy",
"criterions": [
{
"exact_snippets": "No other concurrent anticancer therapy",
"criterion": "concurrent anticancer therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"line": "PATIENT CHARACTERISTICS:",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "Other",
"criterions": []
},
{
"line": "* Not pregnant or nursing",
"criterions": [
{
"exact_snippets": "Not pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
},
{
"exact_snippets": "not ... nursing",
"criterion": "nursing",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
}
]
},
{
"line": "Other",
"criterions": []
}
]
}