{
    "info": {
        "nct_id": "NCT01495676",
        "official_title": "A Randomized Phase II Trial Evaluating an Organ-conserving Strategy With Radiotherapy + CDDP + Gemcitabine vs Radiotherapy + CDDP in Muscle-infiltrative Bladder Cancer",
        "inclusion_criteria": "* Muscle invasive urothelial cancer (front line or following the progression of a superficial tumor), pT2-pT3 stage without lymphatic impairment (N0) and without detectable metastases (M0). An optimal macroscopic resection (TURB) have to be performed\n* The proof of invasive tumor to the muscle should be brought by a transurethral resection under anaesthesia less than 8 weeks before or, in the absence, by superficial biopsies and formal imaging. Multiples biopsies in the bladder must also be performed.\n* Age ≥ 18 years\n* Life expectancy ≥ 6 months\n* Kanorfsky index ≥ 70 % (WHO 0, 1, 2)\n* Biological criteria: neutrophils ≥ 1500/mm3, Platelets ≥ 100 000/mm3, haemoglobin ≥ 10 g/dl, creatinine clearance > 60 ml/mn\n* No distant metastases (Thorax, abdomen, and pelvic CT-scan, bone scan)\n* Efficient contraception for premenopausal women, maintained during the whole treatment and up to two months after the completion of radiotherapy.\n* No radiotherapy or chemotherapy history except for in situ bladder lesions.\n* No carcinological history except for non melanoma skin tumours, in situ uterine cervix cancer\n* No contraindication to gemcitabine or cisplatin.\n* No contraindication to radiotherapy\n* Information letter and informed consent signed\n* Patient covered by social security\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Bladder tumors without any muscle infiltration\n* Epidermoid carcinoma or adenocarcinoma\n* Distance metastases or extrapelvic node positivity\n* Severe digestive history (ulcerative colitis, complicated diverticulitis)\n* Pregnancy and breast feeding",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Muscle invasive urothelial cancer (front line or following the progression of a superficial tumor), pT2-pT3 stage without lymphatic impairment (N0) and without detectable metastases (M0). An optimal macroscopic resection (TURB) have to be performed",
            "criterions": [
                {
                    "exact_snippets": "Muscle invasive urothelial cancer",
                    "criterion": "urothelial cancer",
                    "requirements": [
                        {
                            "requirement_type": "invasiveness",
                            "expected_value": "muscle invasive"
                        }
                    ]
                },
                {
                    "exact_snippets": "pT2-pT3 stage",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "pT2",
                                "pT3"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "without lymphatic impairment (N0)",
                    "criterion": "lymphatic impairment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without detectable metastases (M0)",
                    "criterion": "metastases",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "An optimal macroscopic resection (TURB) have to be performed",
                    "criterion": "macroscopic resection (TURB)",
                    "requirements": [
                        {
                            "requirement_type": "performance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The proof of invasive tumor to the muscle should be brought by a transurethral resection under anaesthesia less than 8 weeks before or, in the absence, by superficial biopsies and formal imaging. Multiples biopsies in the bladder must also be performed.",
            "criterions": [
                {
                    "exact_snippets": "proof of invasive tumor to the muscle",
                    "criterion": "invasive tumor to the muscle",
                    "requirements": [
                        {
                            "requirement_type": "proof",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "transurethral resection under anaesthesia less than 8 weeks before",
                    "criterion": "transurethral resection under anaesthesia",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "superficial biopsies",
                    "criterion": "superficial biopsies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "formal imaging",
                    "criterion": "formal imaging",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Multiples biopsies in the bladder must also be performed",
                    "criterion": "multiple biopsies in the bladder",
                    "requirements": [
                        {
                            "requirement_type": "performance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy ≥ 6 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥ 6 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Kanorfsky index ≥ 70 % (WHO 0, 1, 2)",
            "criterions": [
                {
                    "exact_snippets": "Kanorfsky index ≥ 70 %",
                    "criterion": "Kanorfsky index",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "WHO 0, 1, 2",
                    "criterion": "WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Biological criteria: neutrophils ≥ 1500/mm3, Platelets ≥ 100 000/mm3, haemoglobin ≥ 10 g/dl, creatinine clearance > 60 ml/mn",
            "criterions": [
                {
                    "exact_snippets": "neutrophils ≥ 1500/mm3",
                    "criterion": "neutrophils",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelets ≥ 100 000/mm3",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "haemoglobin ≥ 10 g/dl",
                    "criterion": "haemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "g/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance > 60 ml/mn",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "ml/mn"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No distant metastases (Thorax, abdomen, and pelvic CT-scan, bone scan)",
            "criterions": [
                {
                    "exact_snippets": "No distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Thorax, abdomen, and pelvic CT-scan",
                    "criterion": "CT-scan",
                    "requirements": [
                        {
                            "requirement_type": "regions",
                            "expected_value": [
                                "thorax",
                                "abdomen",
                                "pelvic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "bone scan",
                    "criterion": "bone scan",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Efficient contraception for premenopausal women, maintained during the whole treatment and up to two months after the completion of radiotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Efficient contraception for premenopausal women",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "efficiency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "premenopausal women",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "premenopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "maintained during the whole treatment and up to two months after the completion of radiotherapy",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the whole treatment and up to two months after the completion of radiotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No radiotherapy or chemotherapy history except for in situ bladder lesions.",
            "criterions": [
                {
                    "exact_snippets": "No radiotherapy ... history",
                    "criterion": "radiotherapy history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... chemotherapy history",
                    "criterion": "chemotherapy history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except for in situ bladder lesions",
                    "criterion": "in situ bladder lesions",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No carcinological history except for non melanoma skin tumours, in situ uterine cervix cancer",
            "criterions": [
                {
                    "exact_snippets": "No carcinological history",
                    "criterion": "carcinological history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except for non melanoma skin tumours",
                    "criterion": "non melanoma skin tumours",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... in situ uterine cervix cancer",
                    "criterion": "in situ uterine cervix cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No contraindication to gemcitabine or cisplatin.",
            "criterions": [
                {
                    "exact_snippets": "No contraindication to gemcitabine",
                    "criterion": "contraindication to gemcitabine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No contraindication to ... cisplatin",
                    "criterion": "contraindication to cisplatin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No contraindication to radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "No contraindication to radiotherapy",
                    "criterion": "contraindication to radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Information letter and informed consent signed",
            "criterions": [
                {
                    "exact_snippets": "Information letter and informed consent signed",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient covered by social security",
            "criterions": [
                {
                    "exact_snippets": "Patient covered by social security",
                    "criterion": "social security coverage",
                    "requirements": [
                        {
                            "requirement_type": "coverage",
                            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Bladder tumors without any muscle infiltration",
            "criterions": [
                {
                    "exact_snippets": "Bladder tumors",
                    "criterion": "bladder tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "without any muscle infiltration",
                    "criterion": "muscle infiltration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Epidermoid carcinoma or adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Epidermoid carcinoma",
                    "criterion": "epidermoid carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Distance metastases or extrapelvic node positivity",
            "criterions": [
                {
                    "exact_snippets": "Distance metastases",
                    "criterion": "distance metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "extrapelvic node positivity",
                    "criterion": "extrapelvic node positivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe digestive history (ulcerative colitis, complicated diverticulitis)",
            "criterions": [
                {
                    "exact_snippets": "Severe digestive history (ulcerative colitis, complicated diverticulitis)",
                    "criterion": "digestive history",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "conditions",
                            "expected_value": [
                                "ulcerative colitis",
                                "complicated diverticulitis"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy and breast feeding",
            "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
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}