{
    "info": {
        "nct_id": "NCT03175848",
        "official_title": "Chemotherapy Plus Radiation Therapy in Treating Patients With Primary Stage IVB Cervical Cancer: A Prospective, Single Arm, Phase II Clinical Trial",
        "inclusion_criteria": "1. Biopsy-proven, invasive carcinoma of the cervix(squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma )\n2. KPS≥70\n3. FIGO stage IVB\n4. Age: 18-70\n5. ECOG (Eastern Cooperative Oncology Group) : 0-2\n6. The expected survival time is >6 months\n7. Chemotherapy and radiation have not been done before\n8. Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function)\n9. Able to understand this study and have signed informed consent.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "1. Prior hysterectomy\n2. Metastases lesions are confirmed by pathology or image and are excluded as the second primary neoplasm\n3. Patients with brain metastasis or disseminated peritoneal metastasis\n4. Female in pregnancy or lactating\n5. Hypersensitivity of chemotherapeutic drugs (paclitaxel allergy)\n6. History of major psychiatric disorder\n7. Persons with physical or mental illness, without civil capacity or with limited capacity for civil conduct\n8. Patient with any other disease or condition is a contraindication for chemoradiotherapy\n9. The researchers consider the patient not appropriate to be enrolled",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Biopsy-proven, invasive carcinoma of the cervix(squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma )",
            "criterions": [
                {
                    "exact_snippets": "Biopsy-proven, invasive carcinoma of the cervix",
                    "criterion": "cervical carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous cell carcinoma",
                    "criterion": "squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adenosquamous carcinoma",
                    "criterion": "adenosquamous carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. KPS≥70",
            "criterions": [
                {
                    "exact_snippets": "KPS≥70",
                    "criterion": "Karnofsky Performance Status (KPS)",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. FIGO stage IVB",
            "criterions": [
                {
                    "exact_snippets": "FIGO stage IVB",
                    "criterion": "FIGO stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IVB"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Age: 18-70",
            "criterions": [
                {
                    "exact_snippets": "Age: 18-70",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. ECOG (Eastern Cooperative Oncology Group) : 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG (Eastern Cooperative Oncology Group) : 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. The expected survival time is >6 months",
            "criterions": [
                {
                    "exact_snippets": "expected survival time is >6 months",
                    "criterion": "expected survival time",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Chemotherapy and radiation have not been done before",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy ... have not been done before",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation have not been done before",
                    "criterion": "radiation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function)",
            "criterions": [
                {
                    "exact_snippets": "Normal hemodynamic indices",
                    "criterion": "hemodynamic indices",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "white blood cell count>4.0×109/L",
                    "criterion": "white blood cell count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 4.0,
                                "unit": "×109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "neutrophil count>1.5×109/L",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "×109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count >100×109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "×109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin≥90g/l",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/l"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "normal liver/kidney function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "normal liver/kidney function",
                    "criterion": "kidney function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Able to understand this study and have signed informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Able to understand this study",
                    "criterion": "understanding of the study",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "have signed informed consent",
                    "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 be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Prior hysterectomy",
            "criterions": [
                {
                    "exact_snippets": "Prior hysterectomy",
                    "criterion": "hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Metastases lesions are confirmed by pathology or image and are excluded as the second primary neoplasm",
            "criterions": [
                {
                    "exact_snippets": "Metastases lesions are confirmed by pathology or image",
                    "criterion": "metastases lesions",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "pathology",
                                "image"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Metastases lesions ... are excluded as the second primary neoplasm",
                    "criterion": "metastases lesions",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "second primary neoplasm"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with brain metastasis or disseminated peritoneal metastasis",
            "criterions": [
                {
                    "exact_snippets": "Patients with brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "disseminated peritoneal metastasis",
                    "criterion": "disseminated peritoneal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Female in pregnancy or lactating",
            "criterions": [
                {
                    "exact_snippets": "Female in pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Hypersensitivity of chemotherapeutic drugs (paclitaxel allergy)",
            "criterions": [
                {
                    "exact_snippets": "Hypersensitivity of chemotherapeutic drugs (paclitaxel allergy)",
                    "criterion": "hypersensitivity to chemotherapeutic drugs",
                    "requirements": [
                        {
                            "requirement_type": "specific drug",
                            "expected_value": "paclitaxel"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. History of major psychiatric disorder",
            "criterions": [
                {
                    "exact_snippets": "History of major psychiatric disorder",
                    "criterion": "major psychiatric disorder",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Persons with physical or mental illness, without civil capacity or with limited capacity for civil conduct",
            "criterions": [
                {
                    "exact_snippets": "physical or mental illness",
                    "criterion": "physical or mental illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without civil capacity",
                    "criterion": "civil capacity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "limited capacity for civil conduct",
                    "criterion": "capacity for civil conduct",
                    "requirements": [
                        {
                            "requirement_type": "limitation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patient with any other disease or condition is a contraindication for chemoradiotherapy",
            "criterions": [
                {
                    "exact_snippets": "any other disease or condition is a contraindication for chemoradiotherapy",
                    "criterion": "other disease or condition",
                    "requirements": [
                        {
                            "requirement_type": "contraindication for chemoradiotherapy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. The researchers consider the patient not appropriate to be enrolled",
            "criterions": [
                {
                    "exact_snippets": "The researchers consider the patient not appropriate to be enrolled",
                    "criterion": "appropriateness for enrollment",
                    "requirements": [
                        {
                            "requirement_type": "judgment",
                            "expected_value": "not appropriate"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}