{
"info": {
"nct_id": "NCT00002620",
"official_title": "EFFECT OF DIBROMODULCITOL PLUS BCNU ON FREE INTERVAL AND SURVIVAL OF PATIENTS WITH SUPRATENTORIAL MALIGNANT BRAIN GLIOMAS, A PHASE III TYPE STUDY",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 16 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically confirmed anaplastic astrocytoma Standard maximum resection or stereotactic biopsy required within 4 weeks prior to therapy\n\nPATIENT CHARACTERISTICS: Age: Over 16 Performance status: ECOG/ZUBROD/WHO 0-2 Life expectancy: At least 8 weeks Hematopoietic: WBC greater than 4,000 Platelets greater than 100,000 Hematocrit greater than 30% Hepatic: Bilirubin less than 2 mg/dl Renal: Creatinine less than 1.5 mg/dl Creatinine clearance greater than 70 ml/min BUN less than 40 mg/dl Other: No major medical illness\n\nPRIOR CONCURRENT THERAPY: No anticancer drugs between surgery and protocol treatment No steroids after 10 days following surgery (may be resumed occasionally during radiotherapy)"
},
"inclusion_lines": [
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 16 Years",
"criterions": [
{
"exact_snippets": "minimum age of 16 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 16,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 16 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 16,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "PRIOR CONCURRENT THERAPY: No anticancer drugs between surgery and protocol treatment No steroids after 10 days following surgery (may be resumed occasionally during radiotherapy)",
"criterions": [
{
"exact_snippets": "No anticancer drugs between surgery and protocol treatment",
"criterion": "anticancer drugs",
"requirement": {
"requirement_type": "usage",
"expected_value": false
}
},
{
"exact_snippets": "No steroids after 10 days following surgery",
"criterion": "steroids",
"requirement": {
"requirement_type": "usage",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No anticancer drugs between surgery and protocol treatment",
"criterion": "anticancer drugs",
"requirement": {
"requirement_type": "usage",
"expected_value": false
}
},
{
"exact_snippets": "No steroids after 10 days following surgery",
"criterion": "steroids",
"requirement": {
"requirement_type": "usage",
"expected_value": false
}
}
]
}
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"identified_line": {
"line": "DISEASE CHARACTERISTICS: Histologically confirmed anaplastic astrocytoma Standard maximum resection or stereotactic biopsy required within 4 weeks prior to therapy",
"criterions": [
{
"exact_snippets": "Histologically confirmed anaplastic astrocytoma",
"criterion": "anaplastic astrocytoma",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
}
},
{
"exact_snippets": "Standard maximum resection or stereotactic biopsy required within 4 weeks prior to therapy",
"criterion": "surgical procedure",
"requirement": {
"requirement_type": "type",
"expected_value": [
"standard maximum resection",
"stereotactic biopsy"
]
}
},
{
"exact_snippets": "Standard maximum resection or stereotactic biopsy required within 4 weeks prior to therapy",
"criterion": "surgical procedure",
"requirement": {
"requirement_type": "timing",
"expected_value": "within 4 weeks prior to therapy"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "PATIENT CHARACTERISTICS: Age: Over 16 Performance status: ECOG/ZUBROD/WHO 0-2 Life expectancy: At least 8 weeks Hematopoietic: WBC greater than 4,000 Platelets greater than 100,000 Hematocrit greater than 30% Hepatic: Bilirubin less than 2 mg/dl Renal: Creatinine less than 1.5 mg/dl Creatinine clearance greater than 70 ml/min BUN less than 40 mg/dl Other: No major medical illness",
"criterions": [
{
"exact_snippets": "Age: Over 16",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">",
"value": 16,
"unit": "years"
}
}
},
{
"exact_snippets": "Performance status: ECOG/ZUBROD/WHO 0-2",
"criterion": "performance status",
"requirement": {
"requirement_type": "scale",
"expected_value": [
"ECOG",
"ZUBROD",
"WHO"
]
}
},
{
"exact_snippets": "Performance status: ECOG/ZUBROD/WHO 0-2",
"criterion": "performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "Life expectancy: At least 8 weeks",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "minimum duration",
"expected_value": {
"operator": ">=",
"value": 8,
"unit": "weeks"
}
}
},
{
"exact_snippets": "Hematopoietic: WBC greater than 4,000",
"criterion": "white blood cell count",
"requirement": {
"requirement_type": "minimum count",
"expected_value": {
"operator": ">",
"value": 4000,
"unit": "N/A"
}
}
},
{
"exact_snippets": "Platelets greater than 100,000",
"criterion": "platelet count",
"requirement": {
"requirement_type": "minimum count",
"expected_value": {
"operator": ">",
"value": 100000,
"unit": "N/A"
}
}
},
{
"exact_snippets": "Hematocrit greater than 30%",
"criterion": "hematocrit",
"requirement": {
"requirement_type": "minimum percentage",
"expected_value": {
"operator": ">",
"value": 30,
"unit": "%"
}
}
},
{
"exact_snippets": "Hepatic: Bilirubin less than 2 mg/dl",
"criterion": "bilirubin level",
"requirement": {
"requirement_type": "maximum level",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "mg/dl"
}
}
},
{
"exact_snippets": "Renal: Creatinine less than 1.5 mg/dl",
"criterion": "creatinine level",
"requirement": {
"requirement_type": "maximum level",
"expected_value": {
"operator": "<",
"value": 1.5,
"unit": "mg/dl"
}
}
},
{
"exact_snippets": "Creatinine clearance greater than 70 ml/min",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "minimum clearance",
"expected_value": {
"operator": ">",
"value": 70,
"unit": "ml/min"
}
}
},
{
"exact_snippets": "BUN less than 40 mg/dl",
"criterion": "blood urea nitrogen level",
"requirement": {
"requirement_type": "maximum level",
"expected_value": {
"operator": "<",
"value": 40,
"unit": "mg/dl"
}
}
},
{
"exact_snippets": "Other: No major medical illness",
"criterion": "major medical illness",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
]
}