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