{
    "info": {
        "nct_id": "NCT00003231",
        "official_title": "Preoperative Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases (Stage IIIA, N2)",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically proven stage IIIA non-small cell lung cancer (NSCLC)(including squamous, adenocarcinoma, large cell, and poorly differentiated NSCLC) Nodal metastases of T1-3 N2 M0 No distant metastases\n\nPATIENT CHARACTERISTICS: Age: 18 to 75 Performance Status: WHO 0-2 Life Expectancy: Not specified Hematopoietic: Leucocytes greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin within normal limits AST or ALT no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine clearance greater than 60 mL/min No hypercalcemia Cardiovascular: No unstable cardiac disease No congestive heart failure No angina pectoris No significant arrhythmias No prior history of myocardial infarction within 3 months Pulmonary: Lung function test with a forced expiratory volume greater than 1.2 L/sec Neurologic: No dementia No peripheral neuropathy greater than grade 1 No psychosis No seizure disorders Other: No prior or concurrent malignancies, except: Nonmelanoma skin cancer Carcinoma in situ of the cervix No active uncontrolled infection or other serious medical conditions No diabetes mellitus treated with insulin No gastric ulcers\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: No prior corticosteroids or other endocrine therapy No concurrent treatment with prednisone (except for prophylaxis, treatment of acute hypersensitivity, or chronic treatment initiated greater than 6 months prior to study entry) Radiotherapy: No prior radiotherapy Surgery: No prior surgery for malignancy Other: No concurrent treatment with other experimental drugs No involvement in clinical trials within 30 days of study No prior treatment with other cytostatic 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 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 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS: Histologically proven stage IIIA non-small cell lung cancer (NSCLC)(including squamous, adenocarcinoma, large cell, and poorly differentiated NSCLC) Nodal metastases of T1-3 N2 M0 No distant metastases",
            "criterions": [
                {
                    "exact_snippets": "Histologically proven stage IIIA non-small cell lung cancer (NSCLC)",
                    "criterion": "stage IIIA non-small cell lung cancer (NSCLC)",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous, adenocarcinoma, large cell, and poorly differentiated NSCLC",
                    "criterion": "NSCLC subtype",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": [
                                "squamous",
                                "adenocarcinoma",
                                "large cell",
                                "poorly differentiated"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Nodal metastases of T1-3 N2 M0",
                    "criterion": "nodal metastases",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T1-3 N2 M0"
                        }
                    ]
                },
                {
                    "exact_snippets": "No distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PATIENT CHARACTERISTICS: Age: 18 to 75 Performance Status: WHO 0-2 Life Expectancy: Not specified Hematopoietic: Leucocytes greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin within normal limits AST or ALT no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine clearance greater than 60 mL/min No hypercalcemia Cardiovascular: No unstable cardiac disease No congestive heart failure No angina pectoris No significant arrhythmias No prior history of myocardial infarction within 3 months Pulmonary: Lung function test with a forced expiratory volume greater than 1.2 L/sec Neurologic: No dementia No peripheral neuropathy greater than grade 1 No psychosis No seizure disorders Other: No prior or concurrent malignancies, except: Nonmelanoma skin cancer Carcinoma in situ of the cervix No active uncontrolled infection or other serious medical conditions No diabetes mellitus treated with insulin No gastric ulcers",
            "criterions": [
                {
                    "exact_snippets": "Age: 18 to 75",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance Status: WHO 0-2",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "WHO 0-2"
                        }
                    ]
                },
                {
                    "exact_snippets": "Life Expectancy: Not specified",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": "not specified"
                        }
                    ]
                },
                {
                    "exact_snippets": "Leucocytes greater than 4,000/mm3",
                    "criterion": "leucocytes",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 4000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count greater than 100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Bilirubin within normal limits",
                    "criterion": "bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within normal limits"
                        }
                    ]
                },
                {
                    "exact_snippets": "AST or ALT no greater than 1.5 times upper limit of normal (ULN)",
                    "criterion": "AST or ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alkaline phosphatase no greater than 2.5 times ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine clearance greater than 60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "rate",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No hypercalcemia",
                    "criterion": "hypercalcemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No unstable cardiac disease",
                    "criterion": "unstable cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No significant arrhythmias",
                    "criterion": "significant arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior history of myocardial infarction within 3 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "no prior history within 3 months"
                        }
                    ]
                },
                {
                    "exact_snippets": "Lung function test with a forced expiratory volume greater than 1.2 L/sec",
                    "criterion": "forced expiratory volume",
                    "requirements": [
                        {
                            "requirement_type": "volume",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.2,
                                "unit": "L/sec"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No dementia",
                    "criterion": "dementia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No peripheral neuropathy greater than grade 1",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No psychosis",
                    "criterion": "psychosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No seizure disorders",
                    "criterion": "seizure disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior or concurrent malignancies, except: Nonmelanoma skin cancer Carcinoma in situ of the cervix",
                    "criterion": "prior or concurrent malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "none except nonmelanoma skin cancer, carcinoma in situ of the cervix"
                        }
                    ]
                },
                {
                    "exact_snippets": "No active uncontrolled infection or other serious medical conditions",
                    "criterion": "active uncontrolled infection or other serious medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No diabetes mellitus treated with insulin",
                    "criterion": "diabetes mellitus treated with insulin",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No gastric ulcers",
                    "criterion": "gastric ulcers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: No prior corticosteroids or other endocrine therapy No concurrent treatment with prednisone (except for prophylaxis, treatment of acute hypersensitivity, or chronic treatment initiated greater than 6 months prior to study entry) Radiotherapy: No prior radiotherapy Surgery: No prior surgery for malignancy Other: No concurrent treatment with other experimental drugs No involvement in clinical trials within 30 days of study No prior treatment with other cytostatic therapy",
            "criterions": [
                {
                    "exact_snippets": "No prior biologic therapy",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior corticosteroids or other endocrine therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent treatment with prednisone (except for prophylaxis, treatment of acute hypersensitivity, or chronic treatment initiated greater than 6 months prior to study entry)",
                    "criterion": "prednisone treatment",
                    "requirements": [
                        {
                            "requirement_type": "concurrent treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior surgery for malignancy",
                    "criterion": "surgery for malignancy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent treatment with other experimental drugs",
                    "criterion": "experimental drugs",
                    "requirements": [
                        {
                            "requirement_type": "concurrent treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No involvement in clinical trials within 30 days of study",
                    "criterion": "involvement in clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "time since last involvement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior treatment with other cytostatic therapy",
                    "criterion": "cytostatic therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}