{
    "info": {
        "nct_id": "NCT00023660",
        "official_title": "A Phase I/II Study Of COX-2 Inhibitor, CELEBREX (CELECOXIB), And Chemoradiation In Patients With Locally Advanced Cervical Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 85 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed squamous, adenocarcinoma, or adenosquamous carcinoma of the cervix\n\n  * Stage IIB-IVA OR\n  * Stage IB-IIA with pelvic node metastases and/or tumor size at least 5 cm\n* No small cell, carcinoid, glassy cell, clear cell, or adenoid cystic disease\n* No metastatic disease outside of pelvis\n* No para-aortic disease\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 to 85\n\nPerformance status:\n\n* Zubrod 0-2\n\nLife expectancy:\n\n* At least 6 months\n\nHematopoietic:\n\n* WBC at least 3,000/mm^3\n* Absolute granulocyte count at least 1,500/mm^3\n* Platelet count at least 100,000/mm^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 mg/dL\n* AST or ALT no greater than 2.5 times upper limit of normal (ULN)\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL\n* Creatinine clearance at least 50 mL/min\n* Calcium no greater than 1.3 times ULN\n\nCardiovascular:\n\n* No severe heart disease\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* HIV negative\n* No prior allergy to sulfonamides or non-steroidal anti-inflammatory drugs (NSAIDs)\n* No prior hypersensitivity to celecoxib or any component of its formulation\n* No medical or psychiatric illness that would preclude study\n* No active gastrointestinal (GI) ulcer, GI bleeding, or inflammatory bowel disease\n* No other prior malignancy within the past 5 years except cutaneous basal cell skin cancer\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No recent prior celecoxib or other cyclo-oxygenase-2 inhibitor\n\nChemotherapy:\n\n* No prior systemic chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* No prior radiotherapy to pelvis except transvaginal radiotherapy to control bleeding\n\nSurgery:\n\n* No prior surgery for cervical cancer except biopsy\n\nOther:\n\n* No concurrent phenytoin or lithium\n* No other concurrent NSAIDs"
    },
    "inclusion_lines": [
        {
            "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 be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "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 85 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 85 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 85,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 85 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 85,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "* Histologically confirmed squamous, adenocarcinoma, or adenosquamous carcinoma of the cervix",
                "criterions": [
                    {
                        "exact_snippets": "Histologically confirmed squamous",
                        "criterion": "squamous carcinoma of the cervix",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "Histologically confirmed ... adenocarcinoma",
                        "criterion": "adenocarcinoma of the cervix",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "Histologically confirmed ... adenosquamous carcinoma",
                        "criterion": "adenosquamous carcinoma of the cervix",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Histologically confirmed squamous",
                        "criterion": "squamous carcinoma of the cervix",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "Histologically confirmed ... adenocarcinoma",
                        "criterion": "adenocarcinoma of the cervix",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "Histologically confirmed ... adenosquamous carcinoma",
                        "criterion": "adenosquamous carcinoma of the cervix",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Stage IIB-IVA OR",
                "criterions": [
                    {
                        "exact_snippets": "Stage IIB-IVA",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "B"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Stage IIB-IVA",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "B"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Stage IB-IIA with pelvic node metastases and/or tumor size at least 5 cm",
                "criterions": [
                    {
                        "exact_snippets": "Stage IB-IIA",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IB",
                                "IIA"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "pelvic node metastases",
                        "criterion": "pelvic node metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "tumor size at least 5 cm",
                        "criterion": "tumor size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "cm"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Stage IB-IIA",
                                "criterion": "cancer stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "IB",
                                        "IIA"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "pelvic node metastases",
                                "criterion": "pelvic node metastases",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Stage IB-IIA",
                                "criterion": "cancer stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "IB",
                                        "IIA"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "tumor size at least 5 cm",
                                "criterion": "tumor size",
                                "requirement": {
                                    "requirement_type": "size",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "cm"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No small cell, carcinoid, glassy cell, clear cell, or adenoid cystic disease",
                "criterions": [
                    {
                        "exact_snippets": "No small cell",
                        "criterion": "small cell disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... carcinoid",
                        "criterion": "carcinoid disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... glassy cell",
                        "criterion": "glassy cell disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... clear cell",
                        "criterion": "clear cell disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... adenoid cystic disease",
                        "criterion": "adenoid cystic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No small cell",
                        "criterion": "small cell disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... carcinoid",
                        "criterion": "carcinoid disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... glassy cell",
                        "criterion": "glassy cell disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... clear cell",
                        "criterion": "clear cell disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... adenoid cystic disease",
                        "criterion": "adenoid cystic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No metastatic disease outside of pelvis",
                "criterions": [
                    {
                        "exact_snippets": "No metastatic disease outside of pelvis",
                        "criterion": "metastatic disease",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "pelvis"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No metastatic disease outside of pelvis",
                    "criterion": "metastatic disease",
                    "requirement": {
                        "requirement_type": "location",
                        "expected_value": "pelvis"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* No para-aortic disease",
                "criterions": [
                    {
                        "exact_snippets": "No para-aortic disease",
                        "criterion": "para-aortic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No para-aortic disease",
                    "criterion": "para-aortic disease",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "Age:",
                "criterions": [
                    {
                        "exact_snippets": "Age:",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age:",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* 18 to 85",
                "criterions": [
                    {
                        "exact_snippets": "18 to 85",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 85,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "18 to 85",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 85,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Performance status:",
                "criterions": [
                    {
                        "exact_snippets": "Performance status:",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Performance status:",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Zubrod 0-2",
                "criterions": [
                    {
                        "exact_snippets": "Zubrod 0-2",
                        "criterion": "Zubrod performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Zubrod 0-2",
                        "criterion": "Zubrod performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Life expectancy:",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* At least 6 months",
                "criterions": [
                    {
                        "exact_snippets": "At least 6 months",
                        "criterion": "duration",
                        "requirement": {
                            "requirement_type": "minimum duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "At least 6 months",
                        "criterion": "duration",
                        "requirement": {
                            "requirement_type": "minimum duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Hematopoietic:",
                "criterions": [
                    {
                        "exact_snippets": "Hematopoietic:",
                        "criterion": "hematopoietic system",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hematopoietic:",
                        "criterion": "hematopoietic system",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* WBC at least 3,000/mm^3",
                "criterions": [
                    {
                        "exact_snippets": "WBC at least 3,000/mm^3",
                        "criterion": "WBC",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "WBC at least 3,000/mm^3",
                        "criterion": "WBC",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Absolute granulocyte count at least 1,500/mm^3",
                "criterions": [
                    {
                        "exact_snippets": "Absolute granulocyte count at least 1,500/mm^3",
                        "criterion": "absolute granulocyte count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute granulocyte count at least 1,500/mm^3",
                        "criterion": "absolute granulocyte count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelet count at least 100,000/mm^3",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count at least 100,000/mm^3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelet count at least 100,000/mm^3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Hepatic:",
                "criterions": [
                    {
                        "exact_snippets": "Hepatic:",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hepatic:",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Bilirubin no greater than 1.5 mg/dL",
                "criterions": [
                    {
                        "exact_snippets": "Bilirubin no greater than 1.5 mg/dL",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Bilirubin no greater than 1.5 mg/dL",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
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            "identified_line": {
                "line": "* Not specified",
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                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "PRIOR CONCURRENT THERAPY:",
                "criterions": [
                    {
                        "exact_snippets": "PRIOR CONCURRENT THERAPY",
                        "criterion": "prior concurrent therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Biologic therapy:",
                "criterions": [
                    {
                        "exact_snippets": "Biologic therapy",
                        "criterion": "biologic therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ]
}