{
    "info": {
        "nct_id": "NCT00188565",
        "official_title": "A Phase I/II Trial of Celecoxib With Preoperative Chemoradiation for Resectable Rectal Cancer With In Vivo Analysis of Celecoxib Effector Pathways",
        "inclusion_criteria": "* patients with resectable or potentially resectable adenocarcinoma of the rectum\n* clinical stage T2 N1-2 or T3-4 N0-2 (patients who require diverting loop colostomy are eligible)\n* age greater than 18 years, ECOG performance status < 2 (appendix, section 13.1)\n* biopsy proven adenocarcinoma, superior margin of the tumour within 15cm of the anal verge on rigid sigmoidoscopy\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Distant metastasis, Prior pelvic irradiation, Inflammatory bowel disease, Medical conditions which preclude radical therapy\n* History of malignancy within five years (except nonmelanoma skin cancer, CIN cervix)\n* Pregnancy\n* Hypersensitivity to celecoxib, NSAID, sulfonamides or 5-FU\n* Significant comorbid illness\n* History of peptic ulcer disease or NSAID-related gastrointestinal bleeding\n* Use of aspirin, other NSAID or coxib in the two weeks prior to study entry\n* Neutrophil count <1.5x109/L, platelet count <100x109/L, serum bilirubin >1.25xULN (upper limit of normal), AST/ALT >3xULN, serum creatinine >1.25xULN",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* patients with resectable or potentially resectable adenocarcinoma of the rectum",
            "criterions": [
                {
                    "exact_snippets": "resectable or potentially resectable adenocarcinoma of the rectum",
                    "criterion": "adenocarcinoma of the rectum",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": [
                                "resectable",
                                "potentially resectable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* clinical stage T2 N1-2 or T3-4 N0-2 (patients who require diverting loop colostomy are eligible)",
            "criterions": [
                {
                    "exact_snippets": "clinical stage T2 N1-2 or T3-4 N0-2",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T2 N1-2",
                                "T3-4 N0-2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who require diverting loop colostomy are eligible",
                    "criterion": "diverting loop colostomy",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": "eligible"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* age greater than 18 years, ECOG performance status < 2 (appendix, section 13.1)",
            "criterions": [
                {
                    "exact_snippets": "age greater than 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ECOG performance status < 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* biopsy proven adenocarcinoma, superior margin of the tumour within 15cm of the anal verge on rigid sigmoidoscopy",
            "criterions": [
                {
                    "exact_snippets": "biopsy proven adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "biopsy proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "superior margin of the tumour within 15cm of the anal verge on rigid sigmoidoscopy",
                    "criterion": "tumour location",
                    "requirements": [
                        {
                            "requirement_type": "distance from anal verge",
                            "expected_value": {
                                "operator": "<=",
                                "value": 15,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Distant metastasis, Prior pelvic irradiation, Inflammatory bowel disease, Medical conditions which preclude radical therapy",
            "criterions": [
                {
                    "exact_snippets": "Distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior pelvic irradiation",
                    "criterion": "prior pelvic irradiation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Medical conditions which preclude radical therapy",
                    "criterion": "medical conditions precluding radical therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of malignancy within five years (except nonmelanoma skin cancer, CIN cervix)",
            "criterions": [
                {
                    "exact_snippets": "History of malignancy within five years",
                    "criterion": "history of malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except nonmelanoma skin cancer",
                    "criterion": "nonmelanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... CIN cervix",
                    "criterion": "CIN cervix",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hypersensitivity to celecoxib, NSAID, sulfonamides or 5-FU",
            "criterions": [
                {
                    "exact_snippets": "Hypersensitivity to celecoxib",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "celecoxib"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to ... NSAID",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "NSAID"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to ... sulfonamides",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "sulfonamides"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to ... 5-FU",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "5-FU"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant comorbid illness",
            "criterions": [
                {
                    "exact_snippets": "Significant comorbid illness",
                    "criterion": "comorbid illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of peptic ulcer disease or NSAID-related gastrointestinal bleeding",
            "criterions": [
                {
                    "exact_snippets": "History of peptic ulcer disease",
                    "criterion": "peptic ulcer disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "NSAID-related gastrointestinal bleeding",
                    "criterion": "NSAID-related gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of aspirin, other NSAID or coxib in the two weeks prior to study entry",
            "criterions": [
                {
                    "exact_snippets": "Use of aspirin",
                    "criterion": "aspirin use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "two weeks prior to study entry"
                        }
                    ]
                },
                {
                    "exact_snippets": "other NSAID",
                    "criterion": "NSAID use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "two weeks prior to study entry"
                        }
                    ]
                },
                {
                    "exact_snippets": "coxib",
                    "criterion": "coxib use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "two weeks prior to study entry"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neutrophil count <1.5x109/L, platelet count <100x109/L, serum bilirubin >1.25xULN (upper limit of normal), AST/ALT >3xULN, serum creatinine >1.25xULN",
            "criterions": [
                {
                    "exact_snippets": "Neutrophil count <1.5x109/L",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count <100x109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100,
                                "unit": "x10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum bilirubin >1.25xULN",
                    "criterion": "serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.25,
                                "unit": "xULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST/ALT >3xULN",
                    "criterion": "AST/ALT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "xULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine >1.25xULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.25,
                                "unit": "xULN"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}