{
    "info": {
        "nct_id": "NCT04680260",
        "official_title": "OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer - a ctDNA Guided Phase II Randomized Approach",
        "inclusion_criteria": "* Radical intended treatment for metastatic spread from CRC, by resection, radiofrequency ablation, stereotactic body radiation therapy (or other experimental local treatment options) not including cytoreductive surgery (CRS) and hyperthermic intra-peritoneal chemotherapy (HIPEC)\n* No evidence of further disease based on pre-treatment work-up according to SOC\n* Age at least 18 years\n* Eastern Cooperative Oncology Group performance status 0-2\n* Clinically eligible for adjuvant triple CT at investigators decision.\n* Adequate bone marrow, liver and renal function allowing systemic chemotherapy (Absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l. Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value, and calculated or measured renal glomerular filtration rate at least 30 mL/min)\n* Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable\n* Written and verbally informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Radiological evidence of distant metastasis, by CT- chest, abdomen, and pelvis\n* Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with triple combination chemotherapy\n* Neuropathy National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade > 1\n* Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri\n* Pregnant (positive pregnancy test) or breast feeding women\n* Intolerance or allergy to 5FU, leucovorin, oxaliplatin, irinotecan or capecitabine",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Radical intended treatment for metastatic spread from CRC, by resection, radiofrequency ablation, stereotactic body radiation therapy (or other experimental local treatment options) not including cytoreductive surgery (CRS) and hyperthermic intra-peritoneal chemotherapy (HIPEC)",
            "criterions": [
                {
                    "exact_snippets": "Radical intended treatment for metastatic spread from CRC, by resection",
                    "criterion": "treatment for metastatic spread from CRC",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "resection"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Radical intended treatment for metastatic spread from CRC, by ... radiofrequency ablation",
                    "criterion": "treatment for metastatic spread from CRC",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "radiofrequency ablation"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Radical intended treatment for metastatic spread from CRC, by ... stereotactic body radiation therapy",
                    "criterion": "treatment for metastatic spread from CRC",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "stereotactic body radiation therapy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Radical intended treatment for metastatic spread from CRC, by ... other experimental local treatment options",
                    "criterion": "treatment for metastatic spread from CRC",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "other experimental local treatment options"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not including cytoreductive surgery (CRS)",
                    "criterion": "treatment exclusion",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "cytoreductive surgery (CRS)"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not including ... hyperthermic intra-peritoneal chemotherapy (HIPEC)",
                    "criterion": "treatment exclusion",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "hyperthermic intra-peritoneal chemotherapy (HIPEC)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No evidence of further disease based on pre-treatment work-up according to SOC",
            "criterions": [
                {
                    "exact_snippets": "No evidence of further disease",
                    "criterion": "further disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age at least 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age at least 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group performance status 0-2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group performance status 0-2",
                    "criterion": "Eastern Cooperative Oncology Group performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically eligible for adjuvant triple CT at investigators decision.",
            "criterions": [
                {
                    "exact_snippets": "Clinically eligible for adjuvant triple CT",
                    "criterion": "adjuvant triple CT eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at investigators decision",
                    "criterion": "investigator's decision",
                    "requirements": [
                        {
                            "requirement_type": "decision",
                            "expected_value": "investigator's discretion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable",
            "criterions": [
                {
                    "exact_snippets": "Anticonception for fertile women",
                    "criterion": "anticonception for fertile women",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Anticonception ... for male patients with a fertile partner",
                    "criterion": "anticonception for male patients with a fertile partner",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable",
                    "criterion": "acceptable anticonception methods",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "Intrauterine device",
                                "vasectomy of a female subject's male partner",
                                "hormonal contraceptive"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written and verbally informed consent",
            "criterions": [
                {
                    "exact_snippets": "Written and verbally informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "written",
                                "verbal"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Radiological evidence of distant metastasis, by CT- chest, abdomen, and pelvis",
            "criterions": [
                {
                    "exact_snippets": "Radiological evidence of distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "radiological"
                        }
                    ]
                },
                {
                    "exact_snippets": "CT- chest, abdomen, and pelvis",
                    "criterion": "CT scan",
                    "requirements": [
                        {
                            "requirement_type": "locations",
                            "expected_value": [
                                "chest",
                                "abdomen",
                                "pelvis"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with triple combination chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Incapacity, frailty, disability and comorbidity",
                    "criterion": "incapacity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not compatible with triple combination chemotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Incapacity, frailty, disability and comorbidity",
                    "criterion": "frailty",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not compatible with triple combination chemotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Incapacity, frailty, disability and comorbidity",
                    "criterion": "disability",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not compatible with triple combination chemotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Incapacity, frailty, disability and comorbidity",
                    "criterion": "comorbidity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not compatible with triple combination chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neuropathy National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade > 1",
            "criterions": [
                {
                    "exact_snippets": "Neuropathy National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade > 1",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "NCI-CTCAE grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri",
            "criterions": [
                {
                    "exact_snippets": "Other malignant tumor within 5 years",
                    "criterion": "other malignant tumor",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... carcinoma in situ cervicis uteri",
                    "criterion": "carcinoma in situ cervicis uteri",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant (positive pregnancy test) or breast feeding women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant (positive pregnancy test)",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding women",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Intolerance or allergy to 5FU, leucovorin, oxaliplatin, irinotecan or capecitabine",
            "criterions": [
                {
                    "exact_snippets": "Intolerance or allergy to 5FU",
                    "criterion": "5FU",
                    "requirements": [
                        {
                            "requirement_type": "intolerance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "allergy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Intolerance or allergy to ... leucovorin",
                    "criterion": "leucovorin",
                    "requirements": [
                        {
                            "requirement_type": "intolerance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "allergy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Intolerance or allergy to ... oxaliplatin",
                    "criterion": "oxaliplatin",
                    "requirements": [
                        {
                            "requirement_type": "intolerance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "allergy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Intolerance or allergy to ... irinotecan",
                    "criterion": "irinotecan",
                    "requirements": [
                        {
                            "requirement_type": "intolerance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "allergy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Intolerance or allergy to ... capecitabine",
                    "criterion": "capecitabine",
                    "requirements": [
                        {
                            "requirement_type": "intolerance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "allergy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Adequate bone marrow, liver and renal function allowing systemic chemotherapy (Absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l. Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value, and calculated or measured renal glomerular filtration rate at least 30 mL/min)",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow ... Absolute neutrophil count ≥1.5x109/l",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x10^9/l"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate bone marrow ... thrombocytes ≥ 100x109/l",
                    "criterion": "thrombocytes",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x10^9/l"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... liver function ... Bilirubin ≤ 1.5 x upper normal value",
                    "criterion": "bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x upper normal value"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... liver function ... alanine aminotransferase ≤ 3 x upper normal value",
                    "criterion": "alanine aminotransferase",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x upper normal value"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal function ... calculated or measured renal glomerular filtration rate at least 30 mL/min",
                    "criterion": "renal glomerular filtration rate",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}