{
"info": {
"nct_id": "NCT01218594",
"official_title": "Phase I/II Clinical Trial of Recombinant Human Endostatin in Combination With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer",
"inclusion_criteria": "* 18 years of age\n\n * untreated pathologically confirmed inoperable stage IIIA or IIIB NSCLC\n * weight loss of less than 10% in the past 6 months\n * performance status (PS) of 0 to 1\n * forced vital capacity in 1 second (FEV1) higher than 0.8 L\n * measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).\n * absolute neutrophil count (ANC) of ≥ 1500/μL\n * hemoglobin ≥ 10 mg/dL\n * platelet ≥ 100,000/μL\n * serum creatinine ≤ 1.25 times of upper limit of normal (ULN)\n * calculated creatinine clearance (CrCl) of ≥ 60 ml/min\n * bilirubin 1.5×ULN\n * AST and ALT less than 2.5×ULN\n * alkaline phosphatase less than 5×ULN.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* active infection\n* history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)\n* malnutrition (loss of ≥ 20% of the original body weight)\n* sensor or motor neuropathy > grade I\n* second primary malignancy, except for non-melanoma skin cancer\n* psychiatric illness or social situation that would preclude study compliance\n* pregnant or lactating women\n* preexisting bleeding diatheses or coagulopathy\n* Prior chemotherapy,chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* 18 years of age",
"criterions": [
{
"exact_snippets": "18 years of age",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
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"criterion": "age",
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"unit": "years"
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}
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}
},
{
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"line": "* weight loss of less than 10% in the past 6 months",
"criterions": [
{
"exact_snippets": "weight loss of less than 10% in the past 6 months",
"criterion": "weight loss",
"requirement": {
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"expected_value": {
"operator": "<",
"value": 10,
"unit": "%"
}
}
},
{
"exact_snippets": "weight loss of less than 10% in the past 6 months",
"criterion": "weight loss",
"requirement": {
"requirement_type": "time frame",
"expected_value": "past 6 months"
}
}
]
},
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"and_criteria": [
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"exact_snippets": "weight loss of less than 10% in the past 6 months",
"criterion": "weight loss",
"requirement": {
"requirement_type": "amount",
"expected_value": {
"operator": "<",
"value": 10,
"unit": "%"
}
}
},
{
"exact_snippets": "weight loss of less than 10% in the past 6 months",
"criterion": "weight loss",
"requirement": {
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"expected_value": "past 6 months"
}
}
]
}
},
{
"identified_line": {
"line": "* performance status (PS) of 0 to 1",
"criterions": [
{
"exact_snippets": "performance status (PS) of 0 to 1",
"criterion": "performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
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"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "performance status (PS) of 0 to 1",
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"requirement": {
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"comparisons": [
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"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
}
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}
},
{
"identified_line": {
"line": "* forced vital capacity in 1 second (FEV1) higher than 0.8 L",
"criterions": [
{
"exact_snippets": "forced vital capacity in 1 second (FEV1) higher than 0.8 L",
"criterion": "forced vital capacity in 1 second (FEV1)",
"requirement": {
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"expected_value": {
"operator": ">",
"value": 0.8,
"unit": "L"
}
}
}
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},
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"exact_snippets": "forced vital capacity in 1 second (FEV1) higher than 0.8 L",
"criterion": "forced vital capacity in 1 second (FEV1)",
"requirement": {
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"expected_value": {
"operator": ">",
"value": 0.8,
"unit": "L"
}
}
}
]
}
},
{
"identified_line": {
"line": "* measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).",
"criterions": [
{
"exact_snippets": "measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "evaluation method",
"expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST)"
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)",
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"requirement": {
"requirement_type": "evaluation method",
"expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST)"
}
}
]
}
},
{
"identified_line": {
"line": "* absolute neutrophil count (ANC) of ≥ 1500/μL",
"criterions": [
{
"exact_snippets": "absolute neutrophil count (ANC) of ≥ 1500/μL",
"criterion": "absolute neutrophil count (ANC)",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "μL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "absolute neutrophil count (ANC) of ≥ 1500/μL",
"criterion": "absolute neutrophil count (ANC)",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "μL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* hemoglobin ≥ 10 mg/dL",
"criterions": [
{
"exact_snippets": "hemoglobin ≥ 10 mg/dL",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "mg/dL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "hemoglobin ≥ 10 mg/dL",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "mg/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* platelet ≥ 100,000/μL",
"criterions": [
{
"exact_snippets": "platelet ≥ 100,000/μL",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "/μL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "platelet ≥ 100,000/μL",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "/μL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* calculated creatinine clearance (CrCl) of ≥ 60 ml/min",
"criterions": [
{
"exact_snippets": "calculated creatinine clearance (CrCl) of ≥ 60 ml/min",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 60,
"unit": "ml/min"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "calculated creatinine clearance (CrCl) of ≥ 60 ml/min",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 60,
"unit": "ml/min"
}
}
}
]
}
},
{
"identified_line": {
"line": "* bilirubin 1.5×ULN",
"criterions": [
{
"exact_snippets": "bilirubin 1.5×ULN",
"criterion": "bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "ULN"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "bilirubin 1.5×ULN",
"criterion": "bilirubin",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "ULN"
}
}
}
]
}
},
{
"identified_line": {
"line": "* AST and ALT less than 2.5×ULN",
"criterions": [
{
"exact_snippets": "AST and ALT less than 2.5×ULN",
"criterion": "AST",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 2.5,
"unit": "ULN"
}
}
},
{
"exact_snippets": "AST and ALT less than 2.5×ULN",
"criterion": "ALT",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 2.5,
"unit": "ULN"
}
}
}
]
},
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"exact_snippets": "AST and ALT less than 2.5×ULN",
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"operator": "<",
"value": 2.5,
"unit": "ULN"
}
}
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"unit": "ULN"
}
}
}
]
}
},
{
"identified_line": {
"line": "* alkaline phosphatase less than 5×ULN.",
"criterions": [
{
"exact_snippets": "alkaline phosphatase less than 5×ULN",
"criterion": "alkaline phosphatase",
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"value": 5,
"unit": "ULN"
}
}
}
]
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"operator": "<",
"value": 5,
"unit": "ULN"
}
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
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"expected_value": "healthy"
}
}
]
},
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}
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}
}
],
"exclusion_lines": [
{
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"line": "* sensor or motor neuropathy > grade I",
"criterions": [
{
"exact_snippets": "sensor or motor neuropathy > grade I",
"criterion": "sensor or motor neuropathy",
"requirement": {
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"operator": ">",
"value": 1,
"unit": "grade"
}
}
}
]
},
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}
},
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"expected_value": false
}
},
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"requirement": {
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"expected_value": true
}
}
]
},
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}
},
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}
]
}
}
]
}
},
{
"identified_line": {
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"criterions": [
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"exact_snippets": "psychiatric illness",
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"expected_value": false
}
},
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}
}
]
},
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}
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]
}
},
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"criterion": "pregnancy",
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"expected_value": false
}
},
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"criterion": "lactation",
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}
}
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}
},
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}
}
]
}
},
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"exact_snippets": "preexisting bleeding diatheses",
"criterion": "bleeding diatheses",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "preexisting ... coagulopathy",
"criterion": "coagulopathy",
"requirement": {
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"expected_value": false
}
}
]
},
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}
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"requirement": {
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Prior chemotherapy,chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway",
"criterions": [
{
"exact_snippets": "Prior chemotherapy",
"criterion": "chemotherapy",
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"expected_value": true
}
},
{
"exact_snippets": "chest irradiation therapy",
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}
},
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}
}
]
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}
},
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}
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]
}
}
],
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{
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"line": "* untreated pathologically confirmed inoperable stage IIIA or IIIB NSCLC",
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{
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"expected_value": "untreated"
}
},
{
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"expected_value": true
}
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}
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"requirement": {
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]
}
}
]
},
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}
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{
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}
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]
}
},
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}
}
]
}
},
{
"identified_line": {
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{
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"unit": "Years"
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}
}
},
{
"identified_line": {
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{
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}
}
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],
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}
}
]
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}
}
},
{
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"line": "* history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)",
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{
"exact_snippets": "history of significant cardiac disease",
"criterion": "significant cardiac disease",
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}
},
{
"exact_snippets": "unstable angina",
"criterion": "unstable angina",
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}
},
{
"exact_snippets": "congestive heart failure",
"criterion": "congestive heart failure",
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"expected_value": true
}
},
{
"exact_snippets": "myocardial infarction within the previous 6 months",
"criterion": "myocardial infarction",
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"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "ventricular arrhythmias",
"criterion": "ventricular arrhythmias",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
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}
}
},
{
"identified_line": {
"line": "* malnutrition (loss of ≥ 20% of the original body weight)",
"criterions": [
{
"exact_snippets": "malnutrition (loss of ≥ 20% of the original body weight)",
"criterion": "malnutrition",
"requirement": {
"requirement_type": "weight loss",
"expected_value": {
"operator": ">=",
"value": 20,
"unit": "% of the original body weight"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}