{
    "info": {
        "nct_id": "NCT02607982",
        "official_title": "Long-term Results of Definitive Concurrent Chemoradiotherapy Using Paclitaxel Plus Oxaliplatin in Unresectable Locally Advanced Esophageal Cancer.",
        "inclusion_criteria": "1. Cytologically or histologically confirmed esophageal carcinoma\n2. Age of 20 -80\n3. ECOG performance status: 0-1;\n4. No treatments prior to enrollment;\n5. At least one measurable lesion on CT, MRI or esophageal barium exam;\n6. Normal functions of heart, lung, liver, kidney and bone marrow\n7. Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL\n8. Informed consent signed\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "1. Prior treatments of chemotherapy or irradiation;\n2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;\n3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;\n4. Participating in other clinical trials;\n5. Pregnancy, breast feeding, or not adopting birth control;\n6. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities\n7. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Cytologically or histologically confirmed esophageal carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Cytologically or histologically confirmed esophageal carcinoma",
                    "criterion": "esophageal carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "cytologically",
                                "histologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Age of 20 -80",
            "criterions": [
                {
                    "exact_snippets": "Age of 20 -80",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 20,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. 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": "4. No treatments prior to enrollment;",
            "criterions": [
                {
                    "exact_snippets": "No treatments prior to enrollment",
                    "criterion": "prior treatments",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. At least one measurable lesion on CT, MRI or esophageal barium exam;",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable lesion",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "on CT, MRI or esophageal barium exam",
                    "criterion": "imaging modality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "CT",
                                "MRI",
                                "esophageal barium exam"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL",
            "criterions": [
                {
                    "exact_snippets": "hemoglobulin ≥9 g/dl",
                    "criterion": "hemoglobulin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "neutrophil ≥1.5×109/L",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet (PLT) ≥100×109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine ≤1.5 UNL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "UNL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Informed consent signed",
            "criterions": [
                {
                    "exact_snippets": "Informed consent signed",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Prior treatments of chemotherapy or irradiation;",
            "criterions": [
                {
                    "exact_snippets": "Prior treatments of chemotherapy",
                    "criterion": "prior chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatments of ... irradiation",
                    "criterion": "prior irradiation treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;",
            "criterions": [
                {
                    "exact_snippets": "Poor bone marrow ... functions",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "poor"
                        }
                    ]
                },
                {
                    "exact_snippets": "Poor ... liver ... functions",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "poor"
                        }
                    ]
                },
                {
                    "exact_snippets": "Poor ... kidney functions",
                    "criterion": "kidney function",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "poor"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;",
            "criterions": [
                {
                    "exact_snippets": "complete obstruction of esophagus",
                    "criterion": "esophagus obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "deep esophageal ulcer",
                    "criterion": "esophageal ulcer",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "deep"
                        }
                    ]
                },
                {
                    "exact_snippets": "fistula to mediastinum",
                    "criterion": "fistula to mediastinum",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "haematemesis",
                    "criterion": "haematemesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Participating in other clinical trials;",
            "criterions": [
                {
                    "exact_snippets": "Participating in other clinical trials",
                    "criterion": "participation in other clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Pregnancy, breast feeding, or not adopting birth control;",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breast feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not adopting birth control",
                    "criterion": "adopting birth control",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection",
                    "criterion": "active uncontrolled infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant and uncontrolled major medical conditions including but not limited to: ... symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant and uncontrolled major medical conditions including but not limited to: ... Unstable angina pectoris",
                    "criterion": "Unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant and uncontrolled major medical conditions including but not limited to: ... cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant and uncontrolled major medical conditions including but not limited to: ... psychiatric illness/ social situation that would limit compliance with study requirements",
                    "criterion": "psychiatric illness/social situation",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "would limit compliance with study requirements"
                        }
                    ]
                },
                {
                    "exact_snippets": "any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "risk for toxicities",
                            "expected_value": "unacceptably high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;",
            "criterions": [
                {
                    "exact_snippets": "another active malignancy within the past five years",
                    "criterion": "active malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin",
                    "criterion": "specific cancer types",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "cervical cancer in site",
                                "in situ carcinoma of the bladder",
                                "non-melanoma carcinoma of the skin"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "6. Normal functions of heart, lung, liver, kidney and bone marrow",
            "criterions": [
                {
                    "exact_snippets": "Normal functions of heart",
                    "criterion": "heart function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Normal functions of lung",
                    "criterion": "lung function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Normal functions of liver",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Normal functions of kidney",
                    "criterion": "kidney function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Normal functions of bone marrow",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}