{
    "info": {
        "nct_id": "NCT05857631",
        "official_title": "Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study",
        "inclusion_criteria": "1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n2. Histologically confirmed diagnosis of cervical cancer post hysterectomy with intermediate or high-risk features, requiring adjuvant EBRT ± concurrent chemotherapy OR histologically confirmed diagnosis of endometrial cancer post hysterectomy requiring adjuvant (chemo)radiotherapy to pelvis with/without vaginal brachytherapy.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "1. Patients with macroscopic residual disease (R+ resection) postoperatively\n2. Patients requiring extended field radiotherapy (patients with involved para-aortic lymph nodes in cervical or endometrial cancer)\n3. Patients treated with chemotherapy for any prior malignancy at any time\n4. Patients treated with pelvic radiation previously\n5. Patients with human immunodeficiency virus infection\n6. Any preexisting medical conditions that may interfere with the assessment of genitourinary or gastrointestinal toxicity (This includes patients with irritable bowel syndrome, subacute intestinal obstruction, anal incontinence, hemorrhoids precluding analysis of gastro-intestinal toxicities, urinary incontinence, recurrent urinary tract infections)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients with macroscopic residual disease (R+ resection) postoperatively",
            "criterions": [
                {
                    "exact_snippets": "macroscopic residual disease (R+ resection)",
                    "criterion": "macroscopic residual disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients requiring extended field radiotherapy (patients with involved para-aortic lymph nodes in cervical or endometrial cancer)",
            "criterions": [
                {
                    "exact_snippets": "requiring extended field radiotherapy",
                    "criterion": "extended field radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "involved para-aortic lymph nodes",
                    "criterion": "para-aortic lymph nodes involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical or endometrial cancer",
                    "criterion": "cervical or endometrial cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients treated with chemotherapy for any prior malignancy at any time",
            "criterions": [
                {
                    "exact_snippets": "treated with chemotherapy for any prior malignancy",
                    "criterion": "prior chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients treated with pelvic radiation previously",
            "criterions": [
                {
                    "exact_snippets": "Patients treated with pelvic radiation previously",
                    "criterion": "pelvic radiation treatment",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients with human immunodeficiency virus infection",
            "criterions": [
                {
                    "exact_snippets": "human immunodeficiency virus infection",
                    "criterion": "human immunodeficiency virus infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Any preexisting medical conditions that may interfere with the assessment of genitourinary or gastrointestinal toxicity (This includes patients with irritable bowel syndrome, subacute intestinal obstruction, anal incontinence, hemorrhoids precluding analysis of gastro-intestinal toxicities, urinary incontinence, recurrent urinary tract infections)",
            "criterions": [
                {
                    "exact_snippets": "preexisting medical conditions that may interfere with the assessment of genitourinary or gastrointestinal toxicity",
                    "criterion": "preexisting medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "interference with assessment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "irritable bowel syndrome",
                    "criterion": "irritable bowel syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "subacute intestinal obstruction",
                    "criterion": "subacute intestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "anal incontinence",
                    "criterion": "anal incontinence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hemorrhoids precluding analysis of gastro-intestinal toxicities",
                    "criterion": "hemorrhoids",
                    "requirements": [
                        {
                            "requirement_type": "preclusion of analysis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "urinary incontinence",
                    "criterion": "urinary incontinence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrent urinary tract infections",
                    "criterion": "recurrent urinary tract infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "2. Histologically confirmed diagnosis of cervical cancer post hysterectomy with intermediate or high-risk features, requiring adjuvant EBRT ± concurrent chemotherapy OR histologically confirmed diagnosis of endometrial cancer post hysterectomy requiring adjuvant (chemo)radiotherapy to pelvis with/without vaginal brachytherapy.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed diagnosis of cervical cancer",
                    "criterion": "cervical cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "post hysterectomy",
                    "criterion": "hysterectomy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    ]
                },
                {
                    "exact_snippets": "intermediate or high-risk features",
                    "criterion": "risk features",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": [
                                "intermediate",
                                "high"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring adjuvant EBRT ± concurrent chemotherapy",
                    "criterion": "adjuvant therapy requirement",
                    "requirements": [
                        {
                            "requirement_type": "therapy type",
                            "expected_value": [
                                "EBRT",
                                "concurrent chemotherapy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed diagnosis of endometrial cancer",
                    "criterion": "endometrial cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "post hysterectomy",
                    "criterion": "hysterectomy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring adjuvant (chemo)radiotherapy to pelvis",
                    "criterion": "adjuvant therapy requirement",
                    "requirements": [
                        {
                            "requirement_type": "therapy type",
                            "expected_value": "(chemo)radiotherapy to pelvis"
                        }
                    ]
                },
                {
                    "exact_snippets": "with/without vaginal brachytherapy",
                    "criterion": "vaginal brachytherapy",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "with",
                                "without"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}