{
    "info": {
        "nct_id": "NCT02688348",
        "official_title": "Prospective Study of Bladder-Preservation Chemo-Radiotherapy (Partial Bladder Hypo-fractionated Radiotherapy) for Patients With Muscle-Invasive Bladder Cancer",
        "inclusion_criteria": "* Histologically confirmed muscle-invasive urothelial cancer (no histology will be excluded)\n* No pelvic nodal metastases or distant metastases (based on computed tomography [CT], positron emission tomography [PET] or magnetic resonance imaging [MRI])\n* Karnofsky performance status (KPS) >= 70\n* Ability to understand, and willingness to sign, the written informed consent\n* Patient will have either opted for bladder-sparing treatment as compared to radical cystectomy, or deemed medically inoperable\n* Following the recent recommendations from the International Consultation on Urological Diseases-European Association of Urology International Consultation on Bladder Cancer, eligible patients will be those with no hydronephrosis, no extensive carcinoma in situ (CIS), and no tumor invasion into the stroma of the prostate\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients with any evidence of distant metastases\n* Prior pelvic radiotherapy\n* History of Crohn's disease or ulcerative colitis\n* Unable to receive chemotherapy\n* Histologies other than urothelial (eg. squamous cell carcinoma, adenocarcinoma, small cell)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed muscle-invasive urothelial cancer (no histology will be excluded)",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed muscle-invasive urothelial cancer",
                    "criterion": "muscle-invasive urothelial cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "no histology will be excluded",
                    "criterion": "histology",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No pelvic nodal metastases or distant metastases (based on computed tomography [CT], positron emission tomography [PET] or magnetic resonance imaging [MRI])",
            "criterions": [
                {
                    "exact_snippets": "No pelvic nodal metastases",
                    "criterion": "pelvic nodal metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky performance status (KPS) >= 70",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky performance status (KPS) >= 70",
                    "criterion": "Karnofsky performance status (KPS)",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand, and willingness to sign, the written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign",
                    "criterion": "willingness to sign consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient will have either opted for bladder-sparing treatment as compared to radical cystectomy, or deemed medically inoperable",
            "criterions": [
                {
                    "exact_snippets": "opted for bladder-sparing treatment",
                    "criterion": "treatment choice",
                    "requirements": [
                        {
                            "requirement_type": "choice",
                            "expected_value": "bladder-sparing treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "radical cystectomy",
                    "criterion": "treatment choice",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": "compared to radical cystectomy"
                        }
                    ]
                },
                {
                    "exact_snippets": "deemed medically inoperable",
                    "criterion": "medical operability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "medically inoperable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Following the recent recommendations from the International Consultation on Urological Diseases-European Association of Urology International Consultation on Bladder Cancer, eligible patients will be those with no hydronephrosis, no extensive carcinoma in situ (CIS), and no tumor invasion into the stroma of the prostate",
            "criterions": [
                {
                    "exact_snippets": "no hydronephrosis",
                    "criterion": "hydronephrosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no extensive carcinoma in situ (CIS)",
                    "criterion": "extensive carcinoma in situ (CIS)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no tumor invasion into the stroma of the prostate",
                    "criterion": "tumor invasion into the stroma of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Patients with any evidence of distant metastases",
            "criterions": [
                {
                    "exact_snippets": "evidence of distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior pelvic radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Prior pelvic radiotherapy",
                    "criterion": "pelvic radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of Crohn's disease or ulcerative colitis",
            "criterions": [
                {
                    "exact_snippets": "History of Crohn's disease",
                    "criterion": "Crohn's disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... ulcerative colitis",
                    "criterion": "ulcerative colitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable to receive chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Unable to receive chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "ability to receive",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologies other than urothelial (eg. squamous cell carcinoma, adenocarcinoma, small cell)",
            "criterions": [
                {
                    "exact_snippets": "Histologies other than urothelial",
                    "criterion": "histology type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "urothelial"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous cell carcinoma",
                    "criterion": "histology type",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": "squamous cell carcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma",
                    "criterion": "histology type",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": "adenocarcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "small cell",
                    "criterion": "histology type",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": "small cell"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}