{
    "info": {
        "nct_id": "NCT01732380",
        "official_title": "A Multicenter Randomized Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer",
        "inclusion_criteria": "* Confirmed diagnosis of inoperable esophageal cancer(squamous cell carcinoma)\n* Measurable disease according to RECIST criteria\n* Age > 18 years\n* WHO performance score < 2\n* Estimated life expectancy of > 12 weeks\n* Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy\n* Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL\n* Renal function: Cr ≤ 1.25×UNL\n* Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL\n* Documented informed consent to participate in the trial\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* Subjects with distant metastases\n* Pregnancy or breast feeding. Women of childbearing age must use effective contraception\n* Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)\n* Evidence of bleeding diathesis or serious infection\n* pregnant or lactating woman\n* Patient participation in other studies",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Confirmed diagnosis of inoperable esophageal cancer(squamous cell carcinoma)",
                "criterions": [
                    {
                        "exact_snippets": "Confirmed diagnosis of inoperable esophageal cancer",
                        "criterion": "esophageal cancer",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": "confirmed"
                        }
                    },
                    {
                        "exact_snippets": "Confirmed diagnosis of inoperable esophageal cancer",
                        "criterion": "esophageal cancer",
                        "requirement": {
                            "requirement_type": "operability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "squamous cell carcinoma",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "squamous cell carcinoma"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Confirmed diagnosis of inoperable esophageal cancer",
                                "criterion": "esophageal cancer",
                                "requirement": {
                                    "requirement_type": "diagnosis",
                                    "expected_value": "confirmed"
                                }
                            },
                            {
                                "exact_snippets": "Confirmed diagnosis of inoperable esophageal cancer",
                                "criterion": "esophageal cancer",
                                "requirement": {
                                    "requirement_type": "operability",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "squamous cell carcinoma",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "squamous cell carcinoma"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Measurable disease according to RECIST criteria",
                "criterions": [
                    {
                        "exact_snippets": "Measurable disease according to RECIST criteria",
                        "criterion": "disease measurability",
                        "requirement": {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Measurable disease according to RECIST criteria",
                        "criterion": "disease measurability",
                        "requirement": {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST"
                        }
                    }
                ]
            }
        },
        {
            "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": "* WHO performance score < 2",
                "criterions": [
                    {
                        "exact_snippets": "WHO performance score < 2",
                        "criterion": "WHO performance score",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "WHO performance score < 2",
                        "criterion": "WHO performance score",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Estimated life expectancy of > 12 weeks",
                "criterions": [
                    {
                        "exact_snippets": "Estimated life expectancy of > 12 weeks",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Estimated life expectancy of > 12 weeks",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy",
                "criterions": [
                    {
                        "exact_snippets": "appropriate to receive systemic chemotherapy",
                        "criterion": "systemic chemotherapy",
                        "requirement": {
                            "requirement_type": "appropriateness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "appropriate to receive ... pelvic radiotherapy",
                        "criterion": "pelvic radiotherapy",
                        "requirement": {
                            "requirement_type": "appropriateness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "appropriate to receive systemic chemotherapy",
                        "criterion": "systemic chemotherapy",
                        "requirement": {
                            "requirement_type": "appropriateness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "appropriate to receive ... pelvic radiotherapy",
                        "criterion": "pelvic radiotherapy",
                        "requirement": {
                            "requirement_type": "appropriateness",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL",
                "criterions": [
                    {
                        "exact_snippets": "Hematologic function: WBC ≥ 4.0×109/L",
                        "criterion": "WBC",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4.0,
                                "unit": "×10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hematologic function: ... PLT ≥ 80×109/L",
                        "criterion": "PLT",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "×10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hematologic function: ... Hb ≥ 10mg/dL",
                        "criterion": "Hb",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hematologic function: WBC ≥ 4.0×109/L",
                        "criterion": "WBC",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4.0,
                                "unit": "×10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hematologic function: ... PLT ≥ 80×109/L",
                        "criterion": "PLT",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "×10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hematologic function: ... Hb ≥ 10mg/dL",
                        "criterion": "Hb",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Documented informed consent to participate in the trial",
                "criterions": [
                    {
                        "exact_snippets": "Documented informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Documented informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "documentation",
                            "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"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 80 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 80 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 80 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Subjects with distant metastases",
                "criterions": [
                    {
                        "exact_snippets": "distant metastases",
                        "criterion": "distant metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "distant metastases",
                    "criterion": "distant metastases",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)",
                "criterions": [
                    {
                        "exact_snippets": "Serious cardiovascular disease (congestive heart failure ...",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Serious cardiovascular disease ... uncontrollable arrhythmia ...",
                        "criterion": "uncontrollable arrhythmia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Serious cardiovascular disease ... unstable angina ...",
                        "criterion": "unstable angina",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Serious cardiovascular disease ... myocardial infarction ...",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Serious cardiovascular disease ... serious heart valve disease ...",
                        "criterion": "serious heart valve disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Serious cardiovascular disease ... resistant hypertension",
                        "criterion": "resistant hypertension",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Serious cardiovascular disease (congestive heart failure ...",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Serious cardiovascular disease ... uncontrollable arrhythmia ...",
                        "criterion": "uncontrollable arrhythmia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Serious cardiovascular disease ... unstable angina ...",
                        "criterion": "unstable angina",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Serious cardiovascular disease ... myocardial infarction ...",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Serious cardiovascular disease ... serious heart valve disease ...",
                        "criterion": "serious heart valve disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Serious cardiovascular disease ... resistant hypertension",
                        "criterion": "resistant hypertension",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Evidence of bleeding diathesis or serious infection",
                "criterions": [
                    {
                        "exact_snippets": "Evidence of bleeding diathesis",
                        "criterion": "bleeding diathesis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "serious infection",
                        "criterion": "serious infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Evidence of bleeding diathesis",
                        "criterion": "bleeding diathesis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "serious infection",
                        "criterion": "serious infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* pregnant or lactating woman",
                "criterions": [
                    {
                        "exact_snippets": "pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating woman",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating woman",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patient participation in other studies",
                "criterions": [
                    {
                        "exact_snippets": "Patient participation in other studies",
                        "criterion": "participation in other studies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patient participation in other studies",
                        "criterion": "participation in other studies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Renal function: Cr ≤ 1.25×UNL",
                "criterions": [
                    {
                        "exact_snippets": "Renal function: Cr ≤ 1.25×UNL",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "creatinine level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.25,
                                "unit": "UNL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Renal function: Cr \u001f 1.25\u001dUNL",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "creatinine level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.25,
                                "unit": "UNL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL",
                "criterions": [
                    {
                        "exact_snippets": "Hepatic function: BIL ≤ 1.5×UNL",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "UNL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hepatic function: ... ALT/AST ≤ 2.5×UNL",
                        "criterion": "ALT/AST levels",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "UNL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hepatic function: BIL \u0014 1.5\u0015UNL",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "UNL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hepatic function: ... ALT/AST \u0014 2.5\u0015UNL",
                        "criterion": "ALT/AST levels",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "UNL"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Pregnancy or breast feeding. Women of childbearing age must use effective contraception",
                "criterions": [
                    {
                        "exact_snippets": "Pregnancy",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breast feeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Women of childbearing age must use effective contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Pregnancy",
                                "criterion": "pregnancy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "breast feeding",
                                "criterion": "breastfeeding",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Women of childbearing age must use effective contraception",
                                "criterion": "contraception use",
                                "requirement": {
                                    "requirement_type": "necessity",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Women of childbearing age must use effective contraception",
                                "criterion": "childbearing age",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}