{
    "info": {
        "nct_id": "NCT01863862",
        "official_title": "Organ Preservation in Elderly Patients With Rectal Cancer: a Prospective Observational Study",
        "inclusion_criteria": "The initial eligibility criteria\n\n* Age ≥70 years or <70 years in patients with ASA 3+\n* Tumour accessible by digital rectal examination\n* Maximal tumour size (usually length) not more than 5 cm\n* Circumferential bowel wall involvement not larger than 60%\n\nThere will be two groups of patients:\n\n1. Candidates for preoperative (chemo)radiotherapy and local excision: tumour ≤3 cm, non-polipoid cT1, or cT2 or borderline cT3, cN0.\n2. Candidates for preoperative (chemo)radiotherapy and total mesorectal excision: cT2 tumors requiring abdominoperineal excision, or cT3 or resectable cT4 (slight involvement of vagina, prostate or seminal vesicles); cN+ is allowed.\n\nThe final eligibility criterion\n\n• Complete clinical response obtained 8 weeks after chemoradiation or 10 weeks after short-course radiation\nHealthy volunteers allowed\nMust have minimum age of 70 Years",
        "exclusion_criteria": "* Distant metastases\n* Fixed tumour on digital rectal examination",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age ≥70 years or <70 years in patients with ASA 3+",
            "criterions": [
                {
                    "exact_snippets": "Age ≥70 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "<70 years in patients with ASA 3+",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 70,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "<70 years in patients with ASA 3+",
                    "criterion": "ASA score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumour accessible by digital rectal examination",
            "criterions": [
                {
                    "exact_snippets": "Tumour accessible by digital rectal examination",
                    "criterion": "tumour",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": "digital rectal examination"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Maximal tumour size (usually length) not more than 5 cm",
            "criterions": [
                {
                    "exact_snippets": "Maximal tumour size ... not more than 5 cm",
                    "criterion": "tumour size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Circumferential bowel wall involvement not larger than 60%",
            "criterions": [
                {
                    "exact_snippets": "Circumferential bowel wall involvement not larger than 60%",
                    "criterion": "circumferential bowel wall involvement",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Candidates for preoperative (chemo)radiotherapy and local excision: tumour ≤3 cm, non-polipoid cT1, or cT2 or borderline cT3, cN0.",
            "criterions": [
                {
                    "exact_snippets": "Candidates for preoperative (chemo)radiotherapy and local excision",
                    "criterion": "preoperative (chemo)radiotherapy and local excision candidacy",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumour ≤3 cm",
                    "criterion": "tumour size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "non-polipoid cT1",
                    "criterion": "tumour type and stage",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-polipoid"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "cT1"
                        }
                    ]
                },
                {
                    "exact_snippets": "cT2",
                    "criterion": "tumour stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "cT2"
                        }
                    ]
                },
                {
                    "exact_snippets": "borderline cT3",
                    "criterion": "tumour stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "borderline cT3"
                        }
                    ]
                },
                {
                    "exact_snippets": "cN0",
                    "criterion": "nodal involvement",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "cN0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Candidates for preoperative (chemo)radiotherapy and total mesorectal excision: cT2 tumors requiring abdominoperineal excision, or cT3 or resectable cT4 (slight involvement of vagina, prostate or seminal vesicles); cN+ is allowed.",
            "criterions": [
                {
                    "exact_snippets": "cT2 tumors requiring abdominoperineal excision",
                    "criterion": "cT2 tumors",
                    "requirements": [
                        {
                            "requirement_type": "surgical requirement",
                            "expected_value": "abdominoperineal excision"
                        }
                    ]
                },
                {
                    "exact_snippets": "cT3 or resectable cT4 (slight involvement of vagina, prostate or seminal vesicles)",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "cT3",
                                "resectable cT4"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "cN+ is allowed",
                    "criterion": "nodal involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "cN+"
                        }
                    ]
                }
            ]
        },
        {
            "line": "• Complete clinical response obtained 8 weeks after chemoradiation or 10 weeks after short-course radiation",
            "criterions": [
                {
                    "exact_snippets": "Complete clinical response obtained 8 weeks after chemoradiation",
                    "criterion": "complete clinical response after chemoradiation",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Complete clinical response obtained ... 10 weeks after short-course radiation",
                    "criterion": "complete clinical response after short-course radiation",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "=",
                                "value": 10,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 70 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Distant metastases",
            "criterions": [
                {
                    "exact_snippets": "Distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fixed tumour on digital rectal examination",
            "criterions": [
                {
                    "exact_snippets": "Fixed tumour on digital rectal examination",
                    "criterion": "tumour",
                    "requirements": [
                        {
                            "requirement_type": "mobility",
                            "expected_value": "fixed"
                        },
                        {
                            "requirement_type": "detection method",
                            "expected_value": "digital rectal examination"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "The initial eligibility criteria",
            "criterions": []
        },
        {
            "line": "There will be two groups of patients:",
            "criterions": []
        },
        {
            "line": "The final eligibility criterion",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}