{
    "info": {
        "nct_id": "NCT00449020",
        "official_title": "Carboplatin and Irinotecan Concomitantly With Radiation Therapy Followed by Consolidation Chemotherapy With Docetaxel for Locally Advanced Non-Small Cell Lung Cancer (GIA 12177).",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)\n\n  * Stage IIIA or IIIB disease\n* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan\n* No clinically significant malignant pleural or pericardial effusion (i.e., stage IIIB wet disease)\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-1\n* Absolute neutrophil count > 1,500/mm³\n* Platelet count > 100,000/mm³\n* Hemoglobin ≥ 8.0 g/dL\n* Bilirubin normal\n* Alkaline phosphatase (AP), AST, and ALT meeting 1 of the following criteria:\n\n  * AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)\n  * AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN\n  * AP ≤ 5 times ULN AND AST or ALT normal\n* Creatinine < 2.0 times ULN\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment\n* No New York Heart Association class III-IV heart disease\n* No history of serious cardiac disease not adequately controlled\n* No documented myocardial infarction within the past 6 months\n* No congestive heart failure\n* No unstable angina\n* No clinically significant arrhythmia\n* No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80\n* No peripheral neuropathy > grade 1\n* No other malignancy within the past 5 years other than skin cancer\n\nPRIOR CONCURRENT THERAPY:\n\n* More than 3 weeks since prior major surgery\n* No prior systemic chemotherapy, thoracic radiotherapy, or surgical resection for NSCLC"
    },
    "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 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": "* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)",
                    "criterion": "non-small cell lung cancer (NSCLC)",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage IIIA or IIIB disease",
            "criterions": [
                {
                    "exact_snippets": "Stage IIIA or IIIB disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIA",
                                "IIIB"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques",
                    "criterion": "unidimensionally measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ... > 10 mm by spiral CT scan",
                    "criterion": "unidimensionally measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No clinically significant malignant pleural or pericardial effusion (i.e., stage IIIB wet disease)",
            "criterions": [
                {
                    "exact_snippets": "clinically significant malignant pleural or pericardial effusion",
                    "criterion": "malignant pleural or pericardial effusion",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0-1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count > 1,500/mm³",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count > 1,500/mm³",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count > 100,000/mm³",
            "criterions": [
                {
                    "exact_snippets": "Platelet count > 100,000/mm³",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥ 8.0 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 8.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin normal",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin normal",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alkaline phosphatase (AP), AST, and ALT meeting 1 of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Alkaline phosphatase (AP)",
                    "criterion": "alkaline phosphatase (AP)",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "meeting 1 of the following criteria"
                        }
                    ]
                },
                {
                    "exact_snippets": "AST",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "meeting 1 of the following criteria"
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "meeting 1 of the following criteria"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "AP normal",
                    "criterion": "AP level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "AST or ALT ≤ 5 times upper limit of normal (ULN)",
                    "criterion": "AST or ALT level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "AP ≤ 2.5 times ULN",
                    "criterion": "alkaline phosphatase (AP) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST or ALT ≤ 1.5 times ULN",
                    "criterion": "AST or ALT level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AP ≤ 5 times ULN AND AST or ALT normal",
            "criterions": [
                {
                    "exact_snippets": "AP ≤ 5 times ULN",
                    "criterion": "alkaline phosphatase (AP) level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST or ALT normal",
                    "criterion": "AST or ALT level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine < 2.0 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Creatinine < 2.0 times ULN",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception during and for ≥ 3 months after completion of study treatment",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No New York Heart Association class III-IV heart disease",
            "criterions": [
                {
                    "exact_snippets": "No New York Heart Association class III-IV heart disease",
                    "criterion": "New York Heart Association heart disease class",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "class"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of serious cardiac disease not adequately controlled",
            "criterions": [
                {
                    "exact_snippets": "No history of serious cardiac disease",
                    "criterion": "serious cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not adequately controlled",
                    "criterion": "cardiac disease control",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No documented myocardial infarction within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "No documented myocardial infarction within the past 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "No congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No unstable angina",
            "criterions": [
                {
                    "exact_snippets": "No unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No clinically significant arrhythmia",
            "criterions": [
                {
                    "exact_snippets": "No clinically significant arrhythmia",
                    "criterion": "clinically significant arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80",
            "criterions": [
                {
                    "exact_snippets": "No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80",
                    "criterion": "severe hypersensitivity reaction to drugs formulated with polysorbate 80",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No peripheral neuropathy > grade 1",
            "criterions": [
                {
                    "exact_snippets": "No peripheral neuropathy > grade 1",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other malignancy within the past 5 years other than skin 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": "other than skin cancer",
                    "criterion": "skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 3 weeks since prior major surgery",
            "criterions": [
                {
                    "exact_snippets": "More than 3 weeks since prior major surgery",
                    "criterion": "time since major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior systemic chemotherapy, thoracic radiotherapy, or surgical resection for NSCLC",
            "criterions": [
                {
                    "exact_snippets": "No prior systemic chemotherapy",
                    "criterion": "systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... thoracic radiotherapy",
                    "criterion": "thoracic radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... surgical resection for NSCLC",
                    "criterion": "surgical resection for NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "PATIENT CHARACTERISTICS:",
            "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
                        }
                    ]
                }
            ]
        }
    ]
}