{
    "info": {
        "nct_id": "NCT00527631",
        "official_title": "Adjuvant Whole Abdominal Intensity Modulated Radiotherapy (IMRT) for High Risk Stage FIGO III Patients With Ovarian Cancer: Pilot Trial of a Phase I/II Study",
        "inclusion_criteria": "* histologically confirmed ovarian cancer stage FIGO III\n* grade 2 or 3\n* maximal typical surgical resection (including at least total abdominal hysterectomy, bilateral adnexectomy, omentectomy, debulking of tumour masses)\n* postoperative residual tumour of less than 1 cm (maximal diameter of largest tumour residual is 1 cm)\n* adjuvant chemotherapy consisting of six courses of carboplatin/paclitaxel or carboplatin/docetaxel\n* complete remission after chemotherapy\n* Karnofsky performance Score >60\n* patients > 18 and < 75 years of age\n* written informed consent\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* stage FIGO I or II\n* stage IV (distal metastasis)\n* stage III R2 > 1 cm\n* delayed wound healing post laparotomy\n* neutrophil count (ANC) < 2000/ml before radiotherapy\n* platelets < 100000/ml\n* connective tissue disease, sclerodermia\n* clinically active renal, hepatic, cardiac, metabolic, respiratory, coagulation or haematopoietic disease\n* participation in another clinical trial\n* patient refusal",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* histologically confirmed ovarian cancer stage FIGO III",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed ovarian cancer",
                    "criterion": "ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "ovarian cancer stage FIGO III",
                    "criterion": "ovarian cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "FIGO III"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* grade 2 or 3",
            "criterions": [
                {
                    "exact_snippets": "grade 2 or 3",
                    "criterion": "grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "2",
                                "3"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* maximal typical surgical resection (including at least total abdominal hysterectomy, bilateral adnexectomy, omentectomy, debulking of tumour masses)",
            "criterions": [
                {
                    "exact_snippets": "maximal typical surgical resection (including at least total abdominal hysterectomy, bilateral adnexectomy, omentectomy, debulking of tumour masses)",
                    "criterion": "surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": "maximal typical"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* postoperative residual tumour of less than 1 cm (maximal diameter of largest tumour residual is 1 cm)",
            "criterions": [
                {
                    "exact_snippets": "postoperative residual tumour of less than 1 cm (maximal diameter of largest tumour residual is 1 cm)",
                    "criterion": "postoperative residual tumour",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* adjuvant chemotherapy consisting of six courses of carboplatin/paclitaxel or carboplatin/docetaxel",
            "criterions": [
                {
                    "exact_snippets": "adjuvant chemotherapy consisting of six courses of carboplatin/paclitaxel or carboplatin/docetaxel",
                    "criterion": "adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "regimen",
                            "expected_value": [
                                "carboplatin/paclitaxel",
                                "carboplatin/docetaxel"
                            ]
                        },
                        {
                            "requirement_type": "courses",
                            "expected_value": {
                                "operator": "=",
                                "value": 6,
                                "unit": "courses"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* complete remission after chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "complete remission after chemotherapy",
                    "criterion": "remission status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "complete remission"
                        }
                    ]
                },
                {
                    "exact_snippets": "complete remission after chemotherapy",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky performance Score >60",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky performance Score >60",
                    "criterion": "Karnofsky performance score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patients > 18 and < 75 years of age",
            "criterions": [
                {
                    "exact_snippets": "patients > 18 and < 75 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* written informed consent",
            "criterions": [
                {
                    "exact_snippets": "written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "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 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* stage FIGO I or II",
            "criterions": [
                {
                    "exact_snippets": "stage FIGO I or II",
                    "criterion": "FIGO stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "II"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* stage IV (distal metastasis)",
            "criterions": [
                {
                    "exact_snippets": "stage IV (distal metastasis)",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        },
                        {
                            "requirement_type": "metastasis",
                            "expected_value": "distal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* stage III R2 > 1 cm",
            "criterions": [
                {
                    "exact_snippets": "stage III",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "III"
                        }
                    ]
                },
                {
                    "exact_snippets": "R2 > 1 cm",
                    "criterion": "R2 resection margin",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* delayed wound healing post laparotomy",
            "criterions": [
                {
                    "exact_snippets": "delayed wound healing post laparotomy",
                    "criterion": "wound healing",
                    "requirements": [
                        {
                            "requirement_type": "timeliness",
                            "expected_value": "delayed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* neutrophil count (ANC) < 2000/ml before radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "neutrophil count (ANC) < 2000/ml",
                    "criterion": "neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2000,
                                "unit": "ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* platelets < 100000/ml",
            "criterions": [
                {
                    "exact_snippets": "platelets < 100000/ml",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100000,
                                "unit": "ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* connective tissue disease, sclerodermia",
            "criterions": [
                {
                    "exact_snippets": "connective tissue disease",
                    "criterion": "connective tissue disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sclerodermia",
                    "criterion": "sclerodermia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* clinically active renal, hepatic, cardiac, metabolic, respiratory, coagulation or haematopoietic disease",
            "criterions": [
                {
                    "exact_snippets": "clinically active renal ... disease",
                    "criterion": "renal disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "clinically active"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically active ... hepatic ... disease",
                    "criterion": "hepatic disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "clinically active"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically active ... cardiac ... disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "clinically active"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically active ... metabolic ... disease",
                    "criterion": "metabolic disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "clinically active"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically active ... respiratory ... disease",
                    "criterion": "respiratory disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "clinically active"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically active ... coagulation ... disease",
                    "criterion": "coagulation disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "clinically active"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically active ... haematopoietic disease",
                    "criterion": "haematopoietic disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "clinically active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* participation in another clinical trial",
            "criterions": [
                {
                    "exact_snippets": "participation in another clinical trial",
                    "criterion": "participation in another clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patient refusal",
            "criterions": [
                {
                    "exact_snippets": "patient refusal",
                    "criterion": "patient consent",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}