{
    "info": {
        "nct_id": "NCT01224665",
        "official_title": "A Phase III Surgical Trial to Evaluate the Benefit of a Standard Versus an Extended Pelvic Lymphadenectomy Performed at Time of Radical Cystectomy for Muscle Invasive Urothelial Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed urothelial carcinoma of the bladder\n\n  * Stage T2, T3, or T4a disease\n\n    * No clinical stage consistent with a low-risk of node metastasis (CIS only, T1)\n    * No T4b disease (fixed lesion)\n  * Disease that requires primary radical cystectomy and lymph node dissection for definitive treatment\n\n    * No laparoscopic surgery\n* Predominant urothelial carcinoma with any of the following elements allowed:\n\n  * Adenocarcinoma\n  * Squamous cell carcinoma\n  * Micropapillary or minor components of other rare phenotype\n  * No pure squamous cell carcinoma or adenocarcinoma\n* No visceral or nodal metastatic disease proximal to the common iliac bifurcation by 2-view chest x-ray and abdominal-pelvic imaging by computerized tomography or MRI of the abdomen and pelvis\n* No intra-operative pelvic lymph node involvement (confirmed by frozen section) at or above the bifurcation of the common iliac vessels in any of the extended template\n\nPATIENT CHARACTERISTICS:\n\n* Zubrod performance status 0-2\n* ALT and AST ≤ upper limit of normal (ULN)*\n* Alkaline phosphatase ≤ ULN*\n* Not pregnant or nursing\n* Fertile patients must use an effective contraception\n* No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or stage I or II cancer from which the patient is in complete remission for the past 5 years\n* Medically suitable to undergo cystectomy, in the physician's opinion NOTE: *Levels may be ≥ ULN provided metastatic disease is excluded using dedicated liver imaging, bone scan, or biopsy.\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior partial cystectomy for invasive bladder cancer\n* No prior pelvic surgery that would obviate a complete extended lymphadenectomy (e.g., aorto-femoral/iliac bypass)\n* Prior neoadjuvant chemotherapy for this cancer allowed provided it has been completed and patient has recovered\n* No prior pelvic irradiation"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 120 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 120 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": [
                {
                    "exact_snippets": "DISEASE CHARACTERISTICS",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed urothelial carcinoma of the bladder",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed urothelial carcinoma of the bladder",
                    "criterion": "urothelial carcinoma of the bladder",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage T2, T3, or T4a disease",
            "criterions": [
                {
                    "exact_snippets": "Stage T2, T3, or T4a disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T2",
                                "T3",
                                "T4a"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No clinical stage consistent with a low-risk of node metastasis (CIS only, T1)",
            "criterions": [
                {
                    "exact_snippets": "clinical stage consistent with a low-risk of node metastasis (CIS only, T1)",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "consistency with low-risk of node metastasis",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "specific stages",
                            "expected_value": [
                                "CIS",
                                "T1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No T4b disease (fixed lesion)",
            "criterions": [
                {
                    "exact_snippets": "No T4b disease (fixed lesion)",
                    "criterion": "T4b disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disease that requires primary radical cystectomy and lymph node dissection for definitive treatment",
            "criterions": [
                {
                    "exact_snippets": "Disease that requires primary radical cystectomy and lymph node dissection for definitive treatment",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment necessity",
                            "expected_value": "primary radical cystectomy and lymph node dissection"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No laparoscopic surgery",
            "criterions": [
                {
                    "exact_snippets": "No laparoscopic surgery",
                    "criterion": "laparoscopic surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Predominant urothelial carcinoma with any of the following elements allowed:",
            "criterions": [
                {
                    "exact_snippets": "Predominant urothelial carcinoma",
                    "criterion": "urothelial carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "predominance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Squamous cell carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Squamous cell carcinoma",
                    "criterion": "squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Micropapillary or minor components of other rare phenotype",
            "criterions": [
                {
                    "exact_snippets": "Micropapillary",
                    "criterion": "micropapillary phenotype",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "minor components of other rare phenotype",
                    "criterion": "rare phenotype",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No pure squamous cell carcinoma or adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "No pure squamous cell carcinoma",
                    "criterion": "squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No pure ... adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No visceral or nodal metastatic disease proximal to the common iliac bifurcation by 2-view chest x-ray and abdominal-pelvic imaging by computerized tomography or MRI of the abdomen and pelvis",
            "criterions": [
                {
                    "exact_snippets": "No visceral or nodal metastatic disease proximal to the common iliac bifurcation",
                    "criterion": "visceral or nodal metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "2-view chest x-ray",
                    "criterion": "chest x-ray",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "2-view"
                        }
                    ]
                },
                {
                    "exact_snippets": "abdominal-pelvic imaging by computerized tomography or MRI of the abdomen and pelvis",
                    "criterion": "abdominal-pelvic imaging",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "computerized tomography",
                                "MRI"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No intra-operative pelvic lymph node involvement (confirmed by frozen section) at or above the bifurcation of the common iliac vessels in any of the extended template",
            "criterions": [
                {
                    "exact_snippets": "No intra-operative pelvic lymph node involvement (confirmed by frozen section)",
                    "criterion": "pelvic lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "at or above the bifurcation of the common iliac vessels",
                    "criterion": "location of lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "at or above the bifurcation of the common iliac vessels"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Zubrod performance status 0-2",
            "criterions": [
                {
                    "exact_snippets": "Zubrod performance status 0-2",
                    "criterion": "Zubrod performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ALT and AST ≤ upper limit of normal (ULN)*",
            "criterions": [
                {
                    "exact_snippets": "ALT ... ≤ upper limit of normal (ULN)",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST ... ≤ upper limit of normal (ULN)",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alkaline phosphatase ≤ ULN*",
            "criterions": [
                {
                    "exact_snippets": "Alkaline phosphatase ≤ ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use an effective contraception",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use an effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "effective"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or stage I or II cancer from which the patient is in complete remission for the past 5 years",
            "criterions": [
                {
                    "exact_snippets": "No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or stage I or II cancer",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "adequately treated basal cell or squamous cell skin cancer",
                                "in situ cervical cancer",
                                "stage I or II cancer"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "stage I or II cancer from which the patient is in complete remission for the past 5 years",
                    "criterion": "complete remission",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medically suitable to undergo cystectomy, in the physician's opinion NOTE: *Levels may be ≥ ULN provided metastatic disease is excluded using dedicated liver imaging, bone scan, or biopsy.",
            "criterions": [
                {
                    "exact_snippets": "Medically suitable to undergo cystectomy",
                    "criterion": "medical suitability for cystectomy",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in the physician's opinion",
                    "criterion": "physician's opinion",
                    "requirements": [
                        {
                            "requirement_type": "opinion",
                            "expected_value": "physician's opinion"
                        }
                    ]
                },
                {
                    "exact_snippets": "Levels may be ≥ ULN",
                    "criterion": "levels",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic disease is excluded",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "using dedicated liver imaging, bone scan, or biopsy",
                    "criterion": "methods to exclude metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "dedicated liver imaging",
                                "bone scan",
                                "biopsy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "See Disease Characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior partial cystectomy for invasive bladder cancer",
            "criterions": [
                {
                    "exact_snippets": "No prior partial cystectomy for invasive bladder cancer",
                    "criterion": "prior partial cystectomy for invasive bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior pelvic surgery that would obviate a complete extended lymphadenectomy (e.g., aorto-femoral/iliac bypass)",
            "criterions": [
                {
                    "exact_snippets": "No prior pelvic surgery that would obviate a complete extended lymphadenectomy",
                    "criterion": "prior pelvic surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "(e.g., aorto-femoral/iliac bypass)",
                    "criterion": "type of prior pelvic surgery",
                    "requirements": [
                        {
                            "requirement_type": "specific types",
                            "expected_value": [
                                "aorto-femoral bypass",
                                "iliac bypass"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior neoadjuvant chemotherapy for this cancer allowed provided it has been completed and patient has recovered",
            "criterions": [
                {
                    "exact_snippets": "Prior neoadjuvant chemotherapy for this cancer allowed",
                    "criterion": "prior neoadjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "provided it has been completed",
                    "criterion": "completion of neoadjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patient has recovered",
                    "criterion": "recovery from neoadjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior pelvic irradiation",
            "criterions": [
                {
                    "exact_snippets": "No prior pelvic irradiation",
                    "criterion": "pelvic irradiation",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ]
}