{
"info": {
"nct_id": "NCT00130780",
"official_title": "Multimodality Treatment for Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) (BEACON Study: Bevacizumab and Chemotherapy for Operable NSCLC)",
"inclusion_criteria": "* Pathologic confirmation of NSCLC at Memorial Sloan-Kettering Cancer Center (MSKCC)\n* Stages IB, IIA, IIB or IIIA (T1-3N0-2M 0) NSCLC\n* Patients must be candidates for resection with curative intent.\n* Measurable disease, defined as at least one lesion that can be accurately measured in at least two dimensions\n* Age >= 18 years\n* Karnofsky performance status >= 70%\n* Normal marrow function: leukocytes >= 3,000/µl; absolute neutrophil count ≥ 1,500µl; platelets >= 100,000 µl; hemoglobin >= 9gm/dl.\n* Adequate renal function, with creatinine <= 1.3 mg/dl or calculated creatinine clearance >= 60ml/min by Cockcroft-Gault equation using parameters of age, weight (kg), and baseline serum creatinine (mg/dl)\n* Adequate hepatic function: total bilirubin within normal limits; AST <= 1.5 X upper limit of normal (UNL); ALT <= 1.5 X UNL; alkaline phosphatase <= 1.5 X UNL.\n* Women of childbearing age must have a negative urine or blood pregnancy test.\n* Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.\n* Patients must have ability to understand and the willingness to sign a written informed consent document.\n* Eligibility criteria for group B: Patients with SQUAMOUS CELL carcinoma or patients with a NON-SQUAMOUS CELL tumor with a large central tumor in proximity to significant blood vessels or any history of hemoptysis will be assigned to group B (preoperative chemotherapy alone without bevacizumab).\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Prior chemotherapy or radiation therapy for NSCLC\n* Prior treatment with bevacizumab or other agents specifically targeting vascular endothelial growth factor (VEGF)\n* Patients with a history of severe hypersensitivity reaction to docetaxel (Taxotere) or other drugs formulated with polysorbate 80\n* Patients with known hypersensitivity to other recombinant human antibodies\n* Patients must not be receiving any other investigational agents.\n* History of stroke or transient ischemic attack (TIA).\n* History of myocardial infarction or unstable angina within the past 12 months.\n* Patients who report a hearing deficit at baseline, even if it does not require a hearing aid or intervention, or interfere with activities of daily life (Common Terminology Criteria for Adverse Events [CTCAE] grade 2 or higher)\n* Peripheral neuropathy > grade 1.\n* Uncontrolled hypertension\n* Esophageal varices, non-healing ulcer, wound, or bone fracture\n* Known HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with the study drugs.\n* Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), symptomatic diverticulitis, or active uncontrolled infection.\n* Women who are pregnant or breast-feeding\n* Psychiatric illness or social situation that would limit compliance with study requirements\n* Exclusion criteria for group A: Patients with SQUAMOUS CELL carcinoma, large central tumor in proximity to significant blood vessels, or any history of hemoptysis (will be excluded from group A (preoperative chemotherapy plus bevacizumab); these patients will be assigned to group B (preoperative chemotherapy).",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Pathologic confirmation of NSCLC at Memorial Sloan-Kettering Cancer Center (MSKCC)",
"criterions": [
{
"exact_snippets": "Pathologic confirmation of NSCLC",
"criterion": "NSCLC",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "at Memorial Sloan-Kettering Cancer Center (MSKCC)",
"criterion": "confirmation location",
"requirement": {
"requirement_type": "location",
"expected_value": "Memorial Sloan-Kettering Cancer Center (MSKCC)"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Pathologic confirmation of NSCLC",
"criterion": "NSCLC",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "at Memorial Sloan-Kettering Cancer Center (MSKCC)",
"criterion": "confirmation location",
"requirement": {
"requirement_type": "location",
"expected_value": "Memorial Sloan-Kettering Cancer Center (MSKCC)"
}
}
]
}
},
{
"identified_line": {
"line": "* Stages IB, IIA, IIB or IIIA (T1-3N0-2M 0) NSCLC",
"criterions": [
{
"exact_snippets": "Stages IB, IIA, IIB or IIIA",
"criterion": "NSCLC stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"IB",
"IIA",
"IIB",
"IIIA"
]
}
},
{
"exact_snippets": "T1-3N0-2M 0",
"criterion": "TNM classification",
"requirement": {
"requirement_type": "T",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "T1-3N0-2M 0",
"criterion": "TNM classification",
"requirement": {
"requirement_type": "N",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "T1-3N0-2M 0",
"criterion": "TNM classification",
"requirement": {
"requirement_type": "M",
"expected_value": {
"operator": "=",
"value": 0,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Stages IB, IIA, IIB or IIIA",
"criterion": "NSCLC stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"IB",
"IIA",
"IIB",
"IIIA"
]
}
},
{
"exact_snippets": "T1-3N0-2M 0",
"criterion": "TNM classification",
"requirement": {
"requirement_type": "T",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "T1-3N0-2M 0",
"criterion": "TNM classification",
"requirement": {
"requirement_type": "N",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "T1-3N0-2M 0",
"criterion": "TNM classification",
"requirement": {
"requirement_type": "M",
"expected_value": {
"operator": "=",
"value": 0,
"unit": "N/A"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients must be candidates for resection with curative intent.",
"criterions": [
{
"exact_snippets": "candidates for resection with curative intent",
"criterion": "resection candidacy",
"requirement": {
"requirement_type": "intent",
"expected_value": "curative"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "candidates for resection with curative intent",
"criterion": "resection candidacy",
"requirement": {
"requirement_type": "intent",
"expected_value": "curative"
}
}
]
}
},
{
"identified_line": {
"line": "* Measurable disease, defined as at least one lesion that can be accurately measured in at least two dimensions",
"criterions": [
{
"exact_snippets": "Measurable disease, defined as at least one lesion that can be accurately measured in at least two dimensions",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "definition",
"expected_value": "at least one lesion that can be accurately measured in at least two dimensions"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Measurable disease, defined as at least one lesion that can be accurately measured in at least two dimensions",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "definition",
"expected_value": "at least one lesion that can be accurately measured in at least two dimensions"
}
}
]
}
},
{
"identified_line": {
"line": "* Age >= 18 years",
"criterions": [
{
"exact_snippets": "Age >= 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age >= 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Karnofsky performance status >= 70%",
"criterions": [
{
"exact_snippets": "Karnofsky performance status >= 70%",
"criterion": "Karnofsky performance status",
"requirement": {
"requirement_type": "performance level",
"expected_value": {
"operator": ">=",
"value": 70,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Karnofsky performance status >= 70%",
"criterion": "Karnofsky performance status",
"requirement": {
"requirement_type": "performance level",
"expected_value": {
"operator": ">=",
"value": 70,
"unit": "%"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Normal marrow function: leukocytes >= 3,000/µl; absolute neutrophil count ≥ 1,500µl; platelets >= 100,000 µl; hemoglobin >= 9gm/dl.",
"criterions": [
{
"exact_snippets": "Normal marrow function: leukocytes >= 3,000/µl",
"criterion": "leukocytes",
"requirement": {
"requirement_type": "count",
"expected_value": {
"operator": ">=",
"value": 3000,
"unit": "/µl"
}
}
},
{
"exact_snippets": "Normal marrow function: ... absolute neutrophil count ≥ 1,500µl",
"criterion": "absolute neutrophil count",
"requirement": {
"requirement_type": "count",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "µl"
}
}
},
{
"exact_snippets": "Normal marrow function: ... platelets >= 100,000 µl",
"criterion": "platelets",
"requirement": {
"requirement_type": "count",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "µl"
}
}
},
{
"exact_snippets": "Normal marrow function: ... hemoglobin >= 9gm/dl",
"criterion": "hemoglobin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 9,
"unit": "gm/dl"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Normal marrow function: leukocytes >= 3,000/µl",
"criterion": "leukocytes",
"requirement": {
"requirement_type": "count",
"expected_value": {
"operator": ">=",
"value": 3000,
"unit": "/µl"
}
}
},
{
"exact_snippets": "Normal marrow function: ... absolute neutrophil count ≥ 1,500µl",
"criterion": "absolute neutrophil count",
"requirement": {
"requirement_type": "count",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "µl"
}
}
},
{
"exact_snippets": "Normal marrow function: ... platelets >= 100,000 µl",
"criterion": "platelets",
"requirement": {
"requirement_type": "count",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "µl"
}
}
},
{
"exact_snippets": "Normal marrow function: ... hemoglobin >= 9gm/dl",
"criterion": "hemoglobin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 9,
"unit": "gm/dl"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Adequate renal function, with creatinine <= 1.3 mg/dl or calculated creatinine clearance >= 60ml/min by Cockcroft-Gault equation using parameters of age, weight (kg), and baseline serum creatinine (mg/dl)",
"criterions": [
{
"exact_snippets": "Adequate renal function, with creatinine <= 1.3 mg/dl",
"criterion": "creatinine level",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate renal function, with creatinine <= 1.3 mg/dl",
"criterion": "creatinine level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.3,
"unit": "mg/dl"
}
}
},
{
"exact_snippets": "calculated creatinine clearance >= 60ml/min by Cockcroft-Gault equation",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "calculation",
"expected_value": "Cockcroft-Gault equation"
}
},
{
"exact_snippets": "calculated creatinine clearance >= 60ml/min by Cockcroft-Gault equation",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "clearance",
"expected_value": {
"operator": ">=",
"value": 60,
"unit": "ml/min"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Adequate renal function, with creatinine <= 1.3 mg/dl",
"criterion": "creatinine level",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate renal function, with creatinine <= 1.3 mg/dl",
"criterion": "creatinine level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.3,
"unit": "mg/dl"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "calculated creatinine clearance >= 60ml/min by Cockcroft-Gault equation",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "calculation",
"expected_value": "Cockcroft-Gault equation"
}
},
{
"exact_snippets": "calculated creatinine clearance >= 60ml/min by Cockcroft-Gault equation",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "clearance",
"expected_value": {
"operator": ">=",
"value": 60,
"unit": "ml/min"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Adequate hepatic function: total bilirubin within normal limits; AST <= 1.5 X upper limit of normal (UNL); ALT <= 1.5 X UNL; alkaline phosphatase <= 1.5 X UNL.",
"criterions": [
{
"exact_snippets": "total bilirubin within normal limits",
"criterion": "total bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": "within normal limits"
}
},
{
"exact_snippets": "AST <= 1.5 X upper limit of normal (UNL)",
"criterion": "AST",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "X UNL"
}
}
},
{
"exact_snippets": "ALT <= 1.5 X UNL",
"criterion": "ALT",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "X UNL"
}
}
},
{
"exact_snippets": "alkaline phosphatase <= 1.5 X UNL",
"criterion": "alkaline phosphatase",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "X UNL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "total bilirubin within normal limits",
"criterion": "total bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": "within normal limits"
}
},
{
"exact_snippets": "AST <= 1.5 X upper limit of normal (UNL)",
"criterion": "AST",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "X UNL"
}
}
},
{
"exact_snippets": "ALT <= 1.5 X UNL",
"criterion": "ALT",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "X UNL"
}
}
},
{
"exact_snippets": "alkaline phosphatase <= 1.5 X UNL",
"criterion": "alkaline phosphatase",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "X UNL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Women of childbearing age must have a negative urine or blood pregnancy test.",
"criterions": [
{
"exact_snippets": "Women of childbearing age",
"criterion": "women of childbearing age",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "negative urine or blood pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Women of childbearing age",
"criterion": "women of childbearing age",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"or_criteria": [
{
"exact_snippets": "negative urine or blood pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
}
]
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.",
"criterions": [
{
"exact_snippets": "Men and women of childbearing potential",
"criterion": "childbearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "willing to consent to using effective contraception",
"criterion": "use of effective contraception",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "while on treatment and for at least 3 months thereafter",
"criterion": "duration of contraception use",
"requirement": {
"requirement_type": "duration",
"expected_value": "while on treatment and for at least 3 months thereafter"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Men and women of childbearing potential",
"criterion": "childbearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "willing to consent to using effective contraception",
"criterion": "use of effective contraception",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
{
"exact_snippets": "while on treatment and for at least 3 months thereafter",
"criterion": "duration of contraception use",
"requirement": {
"requirement_type": "duration",
"expected_value": "while on treatment and for at least 3 months thereafter"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients must have ability to understand and the willingness to sign a written informed consent document.",
"criterions": [
{
"exact_snippets": "ability to understand",
"criterion": "cognitive ability",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "willingness to sign a written informed consent document",
"criterion": "willingness to consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "ability to understand",
"criterion": "cognitive ability",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "willingness to sign a written informed consent document",
"criterion": "willingness to consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Eligibility criteria for group B: Patients with SQUAMOUS CELL carcinoma or patients with a NON-SQUAMOUS CELL tumor with a large central tumor in proximity to significant blood vessels or any history of hemoptysis will be assigned to group B (preoperative chemotherapy alone without bevacizumab).",
"criterions": [
{
"exact_snippets": "SQUAMOUS CELL carcinoma",
"criterion": "squamous cell carcinoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "NON-SQUAMOUS CELL tumor",
"criterion": "non-squamous cell tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "large central tumor in proximity to significant blood vessels",
"criterion": "tumor proximity to blood vessels",
"requirement": {
"requirement_type": "proximity",
"expected_value": "significant blood vessels"
}
},
{
"exact_snippets": "any history of hemoptysis",
"criterion": "history of hemoptysis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "NON-SQUAMOUS CELL tumor",
"criterion": "non-squamous cell tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "large central tumor in proximity to significant blood vessels",
"criterion": "tumor proximity to blood vessels",
"requirement": {
"requirement_type": "proximity",
"expected_value": "significant blood vessels"
}
},
{
"exact_snippets": "any history of hemoptysis",
"criterion": "history of hemoptysis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
]
},
{
"exact_snippets": "SQUAMOUS CELL carcinoma",
"criterion": "squamous cell carcinoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"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 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Prior chemotherapy or radiation therapy for NSCLC",
"criterions": [
{
"exact_snippets": "Prior chemotherapy ... for NSCLC",
"criterion": "chemotherapy for NSCLC",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": true
}
},
{
"exact_snippets": "Prior ... radiation therapy for NSCLC",
"criterion": "radiation therapy for NSCLC",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": true
}
}
]
},
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{
"exact_snippets": "Prior chemotherapy ... for NSCLC",
"criterion": "chemotherapy for NSCLC",
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"requirement_type": "prior treatment",
"expected_value": true
}
},
{
"exact_snippets": "Prior ... radiation therapy for NSCLC",
"criterion": "radiation therapy for NSCLC",
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"requirement_type": "prior treatment",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Prior treatment with bevacizumab or other agents specifically targeting vascular endothelial growth factor (VEGF)",
"criterions": [
{
"exact_snippets": "Prior treatment with bevacizumab",
"criterion": "prior treatment",
"requirement": {
"requirement_type": "specific agent",
"expected_value": "bevacizumab"
}
},
{
"exact_snippets": "other agents specifically targeting vascular endothelial growth factor (VEGF)",
"criterion": "prior treatment",
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"requirement_type": "specific target",
"expected_value": "vascular endothelial growth factor (VEGF)"
}
}
]
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"expected_value": "bevacizumab"
}
},
{
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"expected_value": "vascular endothelial growth factor (VEGF)"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with a history of severe hypersensitivity reaction to docetaxel (Taxotere) or other drugs formulated with polysorbate 80",
"criterions": [
{
"exact_snippets": "history of severe hypersensitivity reaction to docetaxel (Taxotere)",
"criterion": "hypersensitivity reaction to docetaxel",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "history of severe hypersensitivity reaction to docetaxel (Taxotere)",
"criterion": "hypersensitivity reaction to docetaxel",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of severe hypersensitivity reaction to ... other drugs formulated with polysorbate 80",
"criterion": "hypersensitivity reaction to drugs formulated with polysorbate 80",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
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"requirement_type": "history",
"expected_value": true
}
}
]
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"and_criteria": [
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"exact_snippets": "history of severe hypersensitivity reaction to docetaxel (Taxotere)",
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"expected_value": "severe"
}
},
{
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}
}
]
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}
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}
}
]
}
]
}
},
{
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"line": "* Patients with known hypersensitivity to other recombinant human antibodies",
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{
"exact_snippets": "known hypersensitivity to other recombinant human antibodies",
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}
}
]
},
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"exact_snippets": "known hypersensitivity to other recombinant human antibodies",
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"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Patients must not be receiving any other investigational agents.",
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{
"exact_snippets": "Patients must not be receiving any other investigational agents.",
"criterion": "receiving investigational agents",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
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"and_criteria": [
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"exact_snippets": "Patients must not be receiving any other investigational agents.",
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"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* History of stroke or transient ischemic attack (TIA).",
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{
"exact_snippets": "History of stroke",
"criterion": "stroke",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "transient ischemic attack (TIA)",
"criterion": "transient ischemic attack (TIA)",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
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"exact_snippets": "History of stroke",
"criterion": "stroke",
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"expected_value": true
}
},
{
"exact_snippets": "transient ischemic attack (TIA)",
"criterion": "transient ischemic attack (TIA)",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* History of myocardial infarction or unstable angina within the past 12 months.",
"criterions": [
{
"exact_snippets": "History of myocardial infarction",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of myocardial infarction",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 12,
"unit": "months"
}
]
}
}
},
{
"exact_snippets": "unstable angina within the past 12 months",
"criterion": "unstable angina",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "unstable angina within the past 12 months",
"criterion": "unstable angina",
"requirement": {
"requirement_type": "time frame",
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{
"operator": "<=",
"value": 12,
"unit": "months"
}
]
}
}
}
]
},
"logical_structure": {
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"and_criteria": [
{
"exact_snippets": "History of myocardial infarction",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of myocardial infarction",
"criterion": "myocardial infarction",
"requirement": {
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{
"operator": "<=",
"value": 12,
"unit": "months"
}
]
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "unstable angina within the past 12 months",
"criterion": "unstable angina",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "unstable angina within the past 12 months",
"criterion": "unstable angina",
"requirement": {
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{
"operator": "<=",
"value": 12,
"unit": "months"
}
]
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Peripheral neuropathy > grade 1.",
"criterions": [
{
"exact_snippets": "Peripheral neuropathy > grade 1",
"criterion": "peripheral neuropathy",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "grade"
}
}
}
]
},
"logical_structure": {
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"exact_snippets": "Peripheral neuropathy > grade 1",
"criterion": "peripheral neuropathy",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "grade"
}
}
}
}
},
{
"identified_line": {
"line": "* Uncontrolled hypertension",
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{
"exact_snippets": "Uncontrolled hypertension",
"criterion": "hypertension",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Uncontrolled hypertension",
"criterion": "hypertension",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Esophageal varices, non-healing ulcer, wound, or bone fracture",
"criterions": [
{
"exact_snippets": "Esophageal varices",
"criterion": "esophageal varices",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "non-healing ulcer",
"criterion": "non-healing ulcer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "wound",
"criterion": "wound",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "bone fracture",
"criterion": "bone fracture",
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"expected_value": true
}
}
]
},
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"exact_snippets": "Esophageal varices",
"criterion": "esophageal varices",
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"expected_value": true
}
},
{
"exact_snippets": "non-healing ulcer",
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}
},
{
"exact_snippets": "wound",
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"expected_value": true
}
},
{
"exact_snippets": "bone fracture",
"criterion": "bone fracture",
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}
}
]
}
},
{
"identified_line": {
"line": "* Known HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with the study drugs.",
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{
"exact_snippets": "Known HIV-positive patients",
"criterion": "HIV-positive status",
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"expected_value": true
}
},
{
"exact_snippets": "receiving combination anti-retroviral therapy",
"criterion": "combination anti-retroviral therapy",
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"requirement_type": "receiving",
"expected_value": true
}
}
]
},
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"exact_snippets": "Known HIV-positive patients",
"criterion": "HIV-positive status",
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"expected_value": true
}
},
{
"exact_snippets": "receiving combination anti-retroviral therapy",
"criterion": "combination anti-retroviral therapy",
"requirement": {
"requirement_type": "receiving",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), symptomatic diverticulitis, or active uncontrolled infection.",
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{
"exact_snippets": "serious illness or medical condition",
"criterion": "serious illness or medical condition",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "unstable cardiac disease requiring treatment",
"criterion": "unstable cardiac disease",
"requirement": {
"requirement_type": "stability",
"expected_value": "unstable"
}
},
{
"exact_snippets": "unstable cardiac disease requiring treatment",
"criterion": "unstable cardiac disease",
"requirement": {
"requirement_type": "treatment requirement",
"expected_value": true
}
},
{
"exact_snippets": "history of significant neurologic or psychiatric disorders",
"criterion": "significant neurologic or psychiatric disorders",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "psychotic disorders",
"criterion": "psychotic disorders",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "dementia",
"criterion": "dementia",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "seizures",
"criterion": "seizures",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "symptomatic diverticulitis",
"criterion": "symptomatic diverticulitis",
"requirement": {
"requirement_type": "symptomatic",
"expected_value": true
}
},
{
"exact_snippets": "active uncontrolled infection",
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"requirement": {
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}
},
{
"exact_snippets": "active uncontrolled infection",
"criterion": "active uncontrolled infection",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
}
]
},
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{
"and_criteria": [
{
"and_criteria": [
{
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}
},
{
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"criterion": "unstable cardiac disease",
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"requirement_type": "treatment requirement",
"expected_value": true
}
}
]
},
{
"exact_snippets": "serious illness or medical condition",
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"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "history of significant neurologic or psychiatric disorders",
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}
},
{
"or_criteria": [
{
"exact_snippets": "psychotic disorders",
"criterion": "psychotic disorders",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "dementia",
"criterion": "dementia",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "seizures",
"criterion": "seizures",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
]
},
{
"exact_snippets": "symptomatic diverticulitis",
"criterion": "symptomatic diverticulitis",
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}
},
{
"and_criteria": [
{
"exact_snippets": "active uncontrolled infection",
"criterion": "active uncontrolled infection",
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}
},
{
"exact_snippets": "active uncontrolled infection",
"criterion": "active uncontrolled infection",
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"requirement_type": "activity",
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}
}
]
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* Women who are pregnant or breast-feeding",
"criterions": [
{
"exact_snippets": "Women who are pregnant",
"criterion": "pregnancy",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "breast-feeding",
"criterion": "breast-feeding",
"requirement": {
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"expected_value": false
}
}
]
},
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}
}
},
{
"identified_line": {
"line": "* Psychiatric illness or social situation that would limit compliance with study requirements",
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{
"exact_snippets": "Psychiatric illness",
"criterion": "psychiatric illness",
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"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "social situation that would limit compliance with study requirements",
"criterion": "social situation",
"requirement": {
"requirement_type": "impact on compliance",
"expected_value": false
}
}
]
},
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}
}
},
{
"identified_line": {
"line": "* Exclusion criteria for group A: Patients with SQUAMOUS CELL carcinoma, large central tumor in proximity to significant blood vessels, or any history of hemoptysis (will be excluded from group A (preoperative chemotherapy plus bevacizumab); these patients will be assigned to group B (preoperative chemotherapy).",
"criterions": [
{
"exact_snippets": "SQUAMOUS CELL carcinoma",
"criterion": "squamous cell carcinoma",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "large central tumor in proximity to significant blood vessels",
"criterion": "large central tumor proximity to significant blood vessels",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "any history of hemoptysis",
"criterion": "history of hemoptysis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
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}
}
},
{
"identified_line": {
"line": "* Patients who report a hearing deficit at baseline, even if it does not require a hearing aid or intervention, or interfere with activities of daily life (Common Terminology Criteria for Adverse Events [CTCAE] grade 2 or higher)",
"criterions": [
{
"exact_snippets": "Patients who report a hearing deficit at baseline",
"criterion": "hearing deficit",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "CTCAE grade 2 or higher",
"criterion": "hearing deficit",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "CTCAE grade"
}
}
}
]
},
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}
}
}
],
"failed_miscellaneous": []
}