{
    "info": {
        "nct_id": "NCT03034473",
        "official_title": "Translational Validation Study to Examine KFO179-1 Biomarker Scores for the Prediction and Prognosis of Advanced Primary Resectable Rectal Cancer Stages UICC II-IV, With a 5-FU-based Standard Radiochemotherapy Followed by Total Mesorectal Excision.",
        "inclusion_criteria": "* Aged 18 to 85 years, inclusive\n* Histologically confirmed advanced primary rectal cancer localized up to 12 cm above the anocutaneous line (determined with a rigid rectoscope), classified as T3/T4 or N+ carcinomas or with evidence for synchronous, but resectable distant metastases (liver or lung metastases)\n* No specific tumor treatment except colostomy due to tumor stenosis with ileus\n* World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) status ≤2\n* Adequate bone marrow function (WBC >3.0x10^9/L, neutrophils >1.5x10^9/L, thrombocytes >100x10^9/L, hemoglobin ≥10 g/dl)\n* Adequate liver function (bilirubin ≤2.0 mg/dl, SGOT, SGPT, AP, gamma-GT < three point five fold of upper level of normal range\n* serum creatinine < 1.5 mg/dl\n* Written and signed informed consent indicating the understanding of the investigational nature and the study protocol.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 85 Years",
        "exclusion_criteria": "* Pregnant or lactating women\n* Men and women unwilling or unable to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment\n* Prolonged drug, medication or alcohol abuse\n* Previous chemotherapy (up to 2 years before diagnosis of rectal cancer)\n* Previous radiotherapy to the pelvic area\n* Simultaneous therapy with other anti-cancer drugs\n* Participation in a clinical trial in the period 30 days prior to inclusion\n* Patients (man and woman) who are not able or willing to accept treatment and follow-up care according to trial protocol\n* Patients (man and woman) with uncontrolled, serious physical or mental diseases, e.g.: instable cardiac disease in spite of medical treatment, myocardial infarction during the last 3 months prior to start of trial participation\n\n  * neurological or psychiatric dysfunction including dementia or seizure disorder\n  * Disseminated infection or sepsis\n  * Disseminated intravascular coagulopathy\n  * Symptomatic neuropathy (NCI CTC ≥2)\n* Patients with secondary malignancies except basal cell carcinoma of the skin or carcinoma in situ of the cervix, which have been successfully treated. (The inclusion of patients with other tumors that were successfully treated and no recurrence within the last 3-5 years should be discussed before registration in the trial)\n* Chronic diarrhea (>grade 1 according NCI CTCAE)\n* Allergic reaction to platin-derivates or study medication\n* Simultaneous treatment with sorivudine and analogous\n* Known Dihydropyrimidine dehydrogenase deficiency",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Aged 18 to 85 years, inclusive",
                "criterions": [
                    {
                        "exact_snippets": "Aged 18 to 85 years, inclusive",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 85,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Aged 18 to 85 years, inclusive",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 85,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Histologically confirmed advanced primary rectal cancer localized up to 12 cm above the anocutaneous line (determined with a rigid rectoscope), classified as T3/T4 or N+ carcinomas or with evidence for synchronous, but resectable distant metastases (liver or lung metastases)",
                "criterions": [
                    {
                        "exact_snippets": "Histologically confirmed advanced primary rectal cancer",
                        "criterion": "advanced primary rectal cancer",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "localized up to 12 cm above the anocutaneous line",
                        "criterion": "tumor location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "cm above the anocutaneous line"
                            }
                        }
                    },
                    {
                        "exact_snippets": "classified as T3/T4 or N+ carcinomas",
                        "criterion": "cancer classification",
                        "requirement": {
                            "requirement_type": "classification",
                            "expected_value": [
                                "T3",
                                "T4",
                                "N+"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "evidence for synchronous, but resectable distant metastases (liver or lung metastases)",
                        "criterion": "distant metastases",
                        "requirement": {
                            "requirement_type": "synchronous",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "evidence for synchronous, but resectable distant metastases (liver or lung metastases)",
                        "criterion": "distant metastases",
                        "requirement": {
                            "requirement_type": "resectability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "evidence for synchronous, but resectable distant metastases (liver or lung metastases)",
                        "criterion": "distant metastases",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": [
                                "liver",
                                "lung"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Histologically confirmed advanced primary rectal cancer",
                                "criterion": "advanced primary rectal cancer",
                                "requirement": {
                                    "requirement_type": "confirmation method",
                                    "expected_value": "histologically confirmed"
                                }
                            },
                            {
                                "exact_snippets": "localized up to 12 cm above the anocutaneous line",
                                "criterion": "tumor location",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "cm above the anocutaneous line"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "classified as T3/T4 or N+ carcinomas",
                                "criterion": "cancer classification",
                                "requirement": {
                                    "requirement_type": "classification",
                                    "expected_value": [
                                        "T3",
                                        "T4",
                                        "N+"
                                    ]
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "evidence for synchronous, but resectable distant metastases (liver or lung metastases)",
                                        "criterion": "distant metastases",
                                        "requirement": {
                                            "requirement_type": "synchronous",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "evidence for synchronous, but resectable distant metastases (liver or lung metastases)",
                                        "criterion": "distant metastases",
                                        "requirement": {
                                            "requirement_type": "resectability",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "evidence for synchronous, but resectable distant metastases (liver or lung metastases)",
                                        "criterion": "distant metastases",
                                        "requirement": {
                                            "requirement_type": "location",
                                            "expected_value": [
                                                "liver",
                                                "lung"
                                            ]
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No specific tumor treatment except colostomy due to tumor stenosis with ileus",
                "criterions": [
                    {
                        "exact_snippets": "No specific tumor treatment",
                        "criterion": "specific tumor treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "colostomy due to tumor stenosis with ileus",
                        "criterion": "colostomy",
                        "requirement": {
                            "requirement_type": "cause",
                            "expected_value": "tumor stenosis with ileus"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "No specific tumor treatment",
                            "criterion": "specific tumor treatment",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "exact_snippets": "colostomy due to tumor stenosis with ileus",
                        "criterion": "colostomy",
                        "requirement": {
                            "requirement_type": "cause",
                            "expected_value": "tumor stenosis with ileus"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) status ≤2",
                "criterions": [
                    {
                        "exact_snippets": "World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) status ≤2",
                        "criterion": "WHO/ECOG status",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) status ≤2",
                        "criterion": "WHO/ECOG status",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* serum creatinine < 1.5 mg/dl",
                "criterions": [
                    {
                        "exact_snippets": "serum creatinine < 1.5 mg/dl",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "mg/dl"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "serum creatinine < 1.5 mg/dl",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "mg/dl"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Written and signed informed consent indicating the understanding of the investigational nature and the study protocol.",
                "criterions": [
                    {
                        "exact_snippets": "Written and signed informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "indicating the understanding of the investigational nature and the study protocol",
                        "criterion": "understanding of the investigational nature and the study protocol",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Written and signed informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "indicating the understanding of the investigational nature and the study protocol",
                        "criterion": "understanding of the investigational nature and the study protocol",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 85 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 85 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 85,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 85 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 85,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Pregnant or lactating women",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating women",
                        "criterion": "lactation status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating women",
                        "criterion": "lactation status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Men and women unwilling or unable to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment",
                "criterions": [
                    {
                        "exact_snippets": "Men and women unwilling or unable to use highly effective methods of contraception",
                        "criterion": "use of contraception",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Men and women unwilling or unable to use highly effective methods of contraception",
                        "criterion": "use of contraception",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "during treatment and for 6 months (male or female) after the end of treatment",
                        "criterion": "duration of contraception use",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during treatment and for 6 months after the end of treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Men and women unwilling or unable to use highly effective methods of contraception",
                                "criterion": "use of contraception",
                                "requirement": {
                                    "requirement_type": "willingness",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Men and women unwilling or unable to use highly effective methods of contraception",
                                "criterion": "use of contraception",
                                "requirement": {
                                    "requirement_type": "ability",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "during treatment and for 6 months (male or female) after the end of treatment",
                        "criterion": "duration of contraception use",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during treatment and for 6 months after the end of treatment"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prolonged drug, medication or alcohol abuse",
                "criterions": [
                    {
                        "exact_snippets": "Prolonged drug, medication or alcohol abuse",
                        "criterion": "drug abuse",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "prolonged"
                        }
                    },
                    {
                        "exact_snippets": "Prolonged drug, medication or alcohol abuse",
                        "criterion": "medication abuse",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "prolonged"
                        }
                    },
                    {
                        "exact_snippets": "Prolonged drug, medication or alcohol abuse",
                        "criterion": "alcohol abuse",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "prolonged"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Prolonged drug, medication or alcohol abuse",
                        "criterion": "drug abuse",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "prolonged"
                        }
                    },
                    {
                        "exact_snippets": "Prolonged drug, medication or alcohol abuse",
                        "criterion": "medication abuse",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "prolonged"
                        }
                    },
                    {
                        "exact_snippets": "Prolonged drug, medication or alcohol abuse",
                        "criterion": "alcohol abuse",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "prolonged"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Previous chemotherapy (up to 2 years before diagnosis of rectal cancer)",
                "criterions": [
                    {
                        "exact_snippets": "Previous chemotherapy (up to 2 years before diagnosis of rectal cancer)",
                        "criterion": "previous chemotherapy",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Previous chemotherapy (up to 2 years before diagnosis of rectal cancer)",
                    "criterion": "previous chemotherapy",
                    "requirement": {
                        "requirement_type": "time since treatment",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<=",
                                    "value": 2,
                                    "unit": "years"
                                }
                            ]
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Previous radiotherapy to the pelvic area",
                "criterions": [
                    {
                        "exact_snippets": "Previous radiotherapy to the pelvic area",
                        "criterion": "radiotherapy to the pelvic area",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Previous radiotherapy to the pelvic area",
                    "criterion": "radiotherapy to the pelvic area",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Simultaneous therapy with other anti-cancer drugs",
                "criterions": [
                    {
                        "exact_snippets": "Simultaneous therapy with other anti-cancer drugs",
                        "criterion": "simultaneous therapy with other anti-cancer drugs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Simultaneous therapy with other anti-cancer drugs",
                    "criterion": "simultaneous therapy with other anti-cancer drugs",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Participation in a clinical trial in the period 30 days prior to inclusion",
                "criterions": [
                    {
                        "exact_snippets": "Participation in a clinical trial in the period 30 days prior to inclusion",
                        "criterion": "participation in a clinical trial",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Participation in a clinical trial in the period 30 days prior to inclusion",
                    "criterion": "participation in a clinical trial",
                    "requirement": {
                        "requirement_type": "time frame",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<=",
                                    "value": 30,
                                    "unit": "days"
                                }
                            ]
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients (man and woman) who are not able or willing to accept treatment and follow-up care according to trial protocol",
                "criterions": [
                    {
                        "exact_snippets": "Patients (man and woman) who are not able or willing to accept treatment",
                        "criterion": "willingness to accept treatment",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patients (man and woman) who are not able or willing to ... follow-up care according to trial protocol",
                        "criterion": "willingness to follow-up care",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Patients (man and woman) who are not able or willing to accept treatment",
                            "criterion": "willingness to accept treatment",
                            "requirement": {
                                "requirement_type": "willingness",
                                "expected_value": true
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "Patients (man and woman) who are not able or willing to ... follow-up care according to trial protocol",
                            "criterion": "willingness to follow-up care",
                            "requirement": {
                                "requirement_type": "willingness",
                                "expected_value": true
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients (man and woman) with uncontrolled, serious physical or mental diseases, e.g.: instable cardiac disease in spite of medical treatment, myocardial infarction during the last 3 months prior to start of trial participation",
                "criterions": [
                    {
                        "exact_snippets": "uncontrolled, serious physical or mental diseases",
                        "criterion": "physical or mental diseases",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled, serious physical or mental diseases",
                        "criterion": "physical or mental diseases",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "instable cardiac disease in spite of medical treatment",
                        "criterion": "cardiac disease",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "instable cardiac disease in spite of medical treatment",
                        "criterion": "cardiac disease",
                        "requirement": {
                            "requirement_type": "treatment response",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "myocardial infarction during the last 3 months prior to start of trial participation",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "uncontrolled, serious physical or mental diseases",
                                "criterion": "physical or mental diseases",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "uncontrolled, serious physical or mental diseases",
                                "criterion": "physical or mental diseases",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "serious"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "instable cardiac disease in spite of medical treatment",
                                "criterion": "cardiac disease",
                                "requirement": {
                                    "requirement_type": "stability",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "instable cardiac disease in spite of medical treatment",
                                "criterion": "cardiac disease",
                                "requirement": {
                                    "requirement_type": "treatment response",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "myocardial infarction during the last 3 months prior to start of trial participation",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* neurological or psychiatric dysfunction including dementia or seizure disorder",
                "criterions": [
                    {
                        "exact_snippets": "neurological or psychiatric dysfunction",
                        "criterion": "neurological or psychiatric dysfunction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "dementia",
                        "criterion": "dementia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "seizure disorder",
                        "criterion": "seizure disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "neurological or psychiatric dysfunction",
                                "criterion": "neurological or psychiatric dysfunction",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "dementia",
                                "criterion": "dementia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "seizure disorder",
                                "criterion": "seizure disorder",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Disseminated infection or sepsis",
                "criterions": [
                    {
                        "exact_snippets": "Disseminated infection",
                        "criterion": "disseminated infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "sepsis",
                        "criterion": "sepsis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Disseminated infection",
                        "criterion": "disseminated infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "sepsis",
                        "criterion": "sepsis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Disseminated intravascular coagulopathy",
                "criterions": [
                    {
                        "exact_snippets": "Disseminated intravascular coagulopathy",
                        "criterion": "disseminated intravascular coagulopathy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Disseminated intravascular coagulopathy",
                    "criterion": "disseminated intravascular coagulopathy",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Symptomatic neuropathy (NCI CTC ≥2)",
                "criterions": [
                    {
                        "exact_snippets": "Symptomatic neuropathy (NCI CTC ≥2)",
                        "criterion": "neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "NCI CTC"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Symptomatic neuropathy (NCI CTC ≥2)",
                    "criterion": "neuropathy",
                    "requirement": {
                        "requirement_type": "severity",
                        "expected_value": {
                            "operator": ">=",
                            "value": 2,
                            "unit": "NCI CTC"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients with secondary malignancies except basal cell carcinoma of the skin or carcinoma in situ of the cervix, which have been successfully treated. (The inclusion of patients with other tumors that were successfully treated and no recurrence within the last 3-5 years should be discussed before registration in the trial)",
                "criterions": [
                    {
                        "exact_snippets": "Patients with secondary malignancies",
                        "criterion": "secondary malignancies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except basal cell carcinoma of the skin or carcinoma in situ of the cervix, which have been successfully treated",
                        "criterion": "basal cell carcinoma of the skin or carcinoma in situ of the cervix",
                        "requirement": {
                            "requirement_type": "successful treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other tumors that were successfully treated and no recurrence within the last 3-5 years",
                        "criterion": "other tumors",
                        "requirement": {
                            "requirement_type": "successful treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other tumors that were successfully treated and no recurrence within the last 3-5 years",
                        "criterion": "other tumors",
                        "requirement": {
                            "requirement_type": "recurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Patients with secondary malignancies",
                                    "criterion": "secondary malignancies",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "except basal cell carcinoma of the skin or carcinoma in situ of the cervix, which have been successfully treated",
                                        "criterion": "basal cell carcinoma of the skin or carcinoma in situ of the cervix",
                                        "requirement": {
                                            "requirement_type": "successful treatment",
                                            "expected_value": true
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "other tumors that were successfully treated and no recurrence within the last 3-5 years",
                                                "criterion": "other tumors",
                                                "requirement": {
                                                    "requirement_type": "successful treatment",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "other tumors that were successfully treated and no recurrence within the last 3-5 years",
                                                "criterion": "other tumors",
                                                "requirement": {
                                                    "requirement_type": "recurrence",
                                                    "expected_value": {
                                                        "comparisons": [
                                                            {
                                                                "operator": ">=",
                                                                "value": 3,
                                                                "unit": "years"
                                                            },
                                                            {
                                                                "operator": "<=",
                                                                "value": 5,
                                                                "unit": "years"
                                                            }
                                                        ]
                                                    }
                                                }
                                            }
                                        ]
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Chronic diarrhea (>grade 1 according NCI CTCAE)",
                "criterions": [
                    {
                        "exact_snippets": "Chronic diarrhea (>grade 1 according NCI CTCAE)",
                        "criterion": "chronic diarrhea",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "NCI CTCAE grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Chronic diarrhea (>grade 1 according NCI CTCAE)",
                    "criterion": "chronic diarrhea",
                    "requirement": {
                        "requirement_type": "severity",
                        "expected_value": {
                            "operator": ">",
                            "value": 1,
                            "unit": "NCI CTCAE grade"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Allergic reaction to platin-derivates or study medication",
                "criterions": [
                    {
                        "exact_snippets": "Allergic reaction to platin-derivates",
                        "criterion": "allergic reaction to platin-derivates",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Allergic reaction to ... study medication",
                        "criterion": "allergic reaction to study medication",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Allergic reaction to platin-derivates",
                        "criterion": "allergic reaction to platin-derivates",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Allergic reaction to ... study medication",
                        "criterion": "allergic reaction to study medication",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Simultaneous treatment with sorivudine and analogous",
                "criterions": [
                    {
                        "exact_snippets": "Simultaneous treatment with sorivudine",
                        "criterion": "simultaneous treatment",
                        "requirement": {
                            "requirement_type": "medication",
                            "expected_value": "sorivudine"
                        }
                    },
                    {
                        "exact_snippets": "Simultaneous treatment with ... analogous",
                        "criterion": "simultaneous treatment",
                        "requirement": {
                            "requirement_type": "medication",
                            "expected_value": "analogous"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Simultaneous treatment with sorivudine",
                        "criterion": "simultaneous treatment",
                        "requirement": {
                            "requirement_type": "medication",
                            "expected_value": "sorivudine"
                        }
                    },
                    {
                        "exact_snippets": "Simultaneous treatment with ... analogous",
                        "criterion": "simultaneous treatment",
                        "requirement": {
                            "requirement_type": "medication",
                            "expected_value": "analogous"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known Dihydropyrimidine dehydrogenase deficiency",
                "criterions": [
                    {
                        "exact_snippets": "Known Dihydropyrimidine dehydrogenase deficiency",
                        "criterion": "Dihydropyrimidine dehydrogenase deficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Known Dihydropyrimidine dehydrogenase deficiency",
                    "criterion": "Dihydropyrimidine dehydrogenase deficiency",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Adequate bone marrow function (WBC >3.0x10^9/L, neutrophils >1.5x10^9/L, thrombocytes >100x10^9/L, hemoglobin ≥10 g/dl)",
                "criterions": [
                    {
                        "exact_snippets": "Adequate bone marrow function (WBC >3.0x10^9/L",
                        "criterion": "WBC",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3.0,
                                "unit": "x10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate bone marrow function ... neutrophils >1.5x10^9/L",
                        "criterion": "neutrophils",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate bone marrow function ... thrombocytes >100x10^9/L",
                        "criterion": "thrombocytes",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "x10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate bone marrow function ... hemoglobin ≥10 g/dl",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "g/dl"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate bone marrow function (WBC >3.0x10^9/L",
                        "criterion": "WBC",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "x10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate bone marrow function ... neutrophils >1.5x10^9/L",
                        "criterion": "neutrophils",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate bone marrow function ... thrombocytes >100x10^9/L",
                        "criterion": "thrombocytes",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "x10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate bone marrow function ... hemoglobin ≥10 g/dl",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "g/dl"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate liver function (bilirubin ≤2.0 mg/dl, SGOT, SGPT, AP, gamma-GT < three point five fold of upper level of normal range",
                "criterions": [
                    {
                        "exact_snippets": "bilirubin ≤2.0 mg/dl",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dl"
                            }
                        }
                    },
                    {
                        "exact_snippets": "SGOT, SGPT, AP, gamma-GT < three point five fold of upper level of normal range",
                        "criterion": "SGOT level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3.5,
                                "unit": "fold of upper level of normal range"
                            }
                        }
                    },
                    {
                        "exact_snippets": "SGOT, SGPT, AP, gamma-GT < three point five fold of upper level of normal range",
                        "criterion": "SGPT level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3.5,
                                "unit": "fold of upper level of normal range"
                            }
                        }
                    },
                    {
                        "exact_snippets": "SGOT, SGPT, AP, gamma-GT < three point five fold of upper level of normal range",
                        "criterion": "AP level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3.5,
                                "unit": "fold of upper level of normal range"
                            }
                        }
                    },
                    {
                        "exact_snippets": "SGOT, SGPT, AP, gamma-GT < three point five fold of upper level of normal range",
                        "criterion": "gamma-GT level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3.5,
                                "unit": "fold of upper level of normal range"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "bilirubin \u0010.0 mg/dl",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dl"
                            }
                        }
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "SGOT, SGPT, AP, gamma-GT < three point five fold of upper level of normal range",
                                "criterion": "SGOT level",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 3.5,
                                        "unit": "fold of upper level of normal range"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "SGOT, SGPT, AP, gamma-GT < three point five fold of upper level of normal range",
                                "criterion": "SGPT level",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 3.5,
                                        "unit": "fold of upper level of normal range"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "SGOT, SGPT, AP, gamma-GT < three point five fold of upper level of normal range",
                                "criterion": "AP level",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 3.5,
                                        "unit": "fold of upper level of normal range"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "SGOT, SGPT, AP, gamma-GT < three point five fold of upper level of normal range",
                                "criterion": "gamma-GT level",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 3.5,
                                        "unit": "fold of upper level of normal range"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}