{
    "info": {
        "nct_id": "NCT02015923",
        "official_title": "Multicenter Randomized Study in Patients With Colorectal Cancer With Unresectable Metastases. Impact of Resection vs no Resection of the Primary Tumour as a Survival Factor",
        "inclusion_criteria": "* colorectal cancer above to 12 cm from the anal verge\n* unresectable synchronous metastases\n* no contraindications for chemotherapy\n* absence of peritoneal carcinomatosis, central nervous system o bone metastasis.\n* performance status ECOG ≤ 2 (Eastern Cooperative Oncology Group)\n* uncontrolled concomitant medical conditions that may compromise to chemotherapy\n* significant symptomatic cardiac disease\n* not pregnancy or breastfeeding\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Cases of rectal tumours below 12cm from anal verge, or locally advanced tumours invading blood vessels, nerves or bone.\n* Multiple bone metastasis or central nervous system metastasis\n* Other neoplastic disease in the 5 previous years, except squamous or basal cell skin carcinoma or cervical \"in situ\" carcinoma\n* Significant heart disease (chronic congestive heart failure, symptomatic coronary disease) or myocardial infarction in the previous 6 months\n* Peripheral neuropathy\n* Patients who do not give informed consent",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* colorectal cancer above to 12 cm from the anal verge",
            "criterions": [
                {
                    "exact_snippets": [
                        "colorectal cancer"
                    ],
                    "criterion": "colorectal cancer",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "above to 12 cm from the anal verge"
                    ],
                    "criterion": "tumor location",
                    "requirement_type": "location",
                    "expected_value": "above to 12 cm from the anal verge"
                }
            ]
        },
        {
            "line": "* unresectable synchronous metastases",
            "criterions": [
                {
                    "exact_snippets": [
                        "unresectable synchronous metastases"
                    ],
                    "criterion": "metastases",
                    "requirement_type": "resectability",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "unresectable synchronous metastases"
                    ],
                    "criterion": "metastases",
                    "requirement_type": "synchrony",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* no contraindications for chemotherapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "no contraindications for chemotherapy"
                    ],
                    "criterion": "chemotherapy",
                    "requirement_type": "contraindications",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* absence of peritoneal carcinomatosis, central nervous system o bone metastasis.",
            "criterions": [
                {
                    "exact_snippets": [
                        "absence of peritoneal carcinomatosis"
                    ],
                    "criterion": "peritoneal carcinomatosis",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "absence of",
                        "central nervous system",
                        "metastasis"
                    ],
                    "criterion": "central nervous system metastasis",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "absence of",
                        "bone metastasis"
                    ],
                    "criterion": "bone metastasis",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* performance status ECOG ≤ 2 (Eastern Cooperative Oncology Group)",
            "criterions": [
                {
                    "exact_snippets": [
                        "performance status ECOG ≤ 2"
                    ],
                    "criterion": "ECOG performance status",
                    "requirement_type": "value",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* uncontrolled concomitant medical conditions that may compromise to chemotherapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "uncontrolled concomitant medical conditions"
                    ],
                    "criterion": "concomitant medical conditions",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "compromise to chemotherapy"
                    ],
                    "criterion": "chemotherapy",
                    "requirement_type": "compromise",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* significant symptomatic cardiac disease",
            "criterions": [
                {
                    "exact_snippets": [
                        "significant symptomatic cardiac disease"
                    ],
                    "criterion": "cardiac disease",
                    "requirement_type": "severity",
                    "expected_value": "significant"
                },
                {
                    "exact_snippets": [
                        "significant symptomatic cardiac disease"
                    ],
                    "criterion": "cardiac disease",
                    "requirement_type": "symptom presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* not pregnancy or breastfeeding",
            "criterions": [
                {
                    "exact_snippets": [
                        "not pregnancy"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "not",
                        "breastfeeding"
                    ],
                    "criterion": "breastfeeding",
                    "requirement_type": "status",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Cases of rectal tumours below 12cm from anal verge, or locally advanced tumours invading blood vessels, nerves or bone.",
            "criterions": [
                {
                    "exact_snippets": [
                        "rectal tumours below 12cm from anal verge"
                    ],
                    "criterion": "rectal tumour location",
                    "requirement_type": "distance from anal verge",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 12
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "locally advanced tumours invading blood vessels"
                    ],
                    "criterion": "tumour invasion",
                    "requirement_type": "presence",
                    "expected_value": "blood vessels"
                },
                {
                    "exact_snippets": [
                        "locally advanced tumours invading",
                        "nerves"
                    ],
                    "criterion": "tumour invasion",
                    "requirement_type": "presence",
                    "expected_value": "nerves"
                },
                {
                    "exact_snippets": [
                        "locally advanced tumours invading",
                        "bone"
                    ],
                    "criterion": "tumour invasion",
                    "requirement_type": "presence",
                    "expected_value": "bone"
                }
            ]
        },
        {
            "line": "* Multiple bone metastasis or central nervous system metastasis",
            "criterions": [
                {
                    "exact_snippets": [
                        "Multiple bone metastasis"
                    ],
                    "criterion": "bone metastasis",
                    "requirement_type": "quantity",
                    "expected_value": "multiple"
                },
                {
                    "exact_snippets": [
                        "central nervous system metastasis"
                    ],
                    "criterion": "central nervous system metastasis",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Other neoplastic disease in the 5 previous years, except squamous or basal cell skin carcinoma or cervical \"in situ\" carcinoma",
            "criterions": [
                {
                    "exact_snippets": [
                        "Other neoplastic disease in the 5 previous years"
                    ],
                    "criterion": "neoplastic disease",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "except squamous or basal cell skin carcinoma"
                    ],
                    "criterion": "squamous or basal cell skin carcinoma",
                    "requirement_type": "history",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "except",
                        "cervical \"in situ\" carcinoma"
                    ],
                    "criterion": "cervical \"in situ\" carcinoma",
                    "requirement_type": "history",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Significant heart disease (chronic congestive heart failure, symptomatic coronary disease) or myocardial infarction in the previous 6 months",
            "criterions": [
                {
                    "exact_snippets": [
                        "Significant heart disease"
                    ],
                    "criterion": "heart disease",
                    "requirement_type": "severity",
                    "expected_value": "significant"
                },
                {
                    "exact_snippets": [
                        "chronic congestive heart failure"
                    ],
                    "criterion": "congestive heart failure",
                    "requirement_type": "chronicity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "symptomatic coronary disease"
                    ],
                    "criterion": "coronary disease",
                    "requirement_type": "symptomatic",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "myocardial infarction",
                        "in the previous 6 months"
                    ],
                    "criterion": "myocardial infarction",
                    "requirement_type": "recency",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 6
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Peripheral neuropathy",
            "criterions": [
                {
                    "exact_snippets": [
                        "Peripheral neuropathy"
                    ],
                    "criterion": "peripheral neuropathy",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients who do not give informed consent",
            "criterions": [
                {
                    "exact_snippets": [
                        "do not give informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "provision",
                    "expected_value": false
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}