{
    "info": {
        "nct_id": "NCT05496491",
        "official_title": "Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial",
        "inclusion_criteria": "* Histologically confirmed rectal adenocarcinoma\n* cT3, cT4, threatened CRM / MRF, EMVI (+), ≥N1\n* Multidisciplinary tumor board decision for neoadjuvant treatment\n* Tumor distance from the anal verge <15 cm based on endoscopy or magnetic resonance imaging\n* Patient 18 to 80 years old\n* General health condition status WHO 0-1\n* Absence of co-morbidities that may affect treatment\n* Neutrophils >1,500 / mm3, platelets >100,000 / mm3, hemoglobin> 10 g / dL, normal creatinine, and creatinine clearance> 50 mL / min\n* Signed informed consent of the patient\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* Distant metastases\n* Non-resectable cancer\n* Contraindications for the administration of chemotherapy\n* Previous pelvic radiotherapy or chemotherapy\n* History of inflammatory bowel disorders\n* History of angina, acute myocardial infarction or heart failure\n* Active sepsis or systemic infection\n* Untreated physical and mental disability\n* Synchronous malignancy\n* Pregnancy or breast-feeding\n* Lack of compliance with the protocol process\n* Non-granting of signed informed consent",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed rectal adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed rectal adenocarcinoma",
                    "criterion": "rectal adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* cT3, cT4, threatened CRM / MRF, EMVI (+), ≥N1",
            "criterions": [
                {
                    "exact_snippets": "cT3, cT4",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "cT3",
                                "cT4"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "threatened CRM / MRF",
                    "criterion": "circumferential resection margin",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "threatened"
                        }
                    ]
                },
                {
                    "exact_snippets": "EMVI (+)",
                    "criterion": "extramural venous invasion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "≥N1",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Multidisciplinary tumor board decision for neoadjuvant treatment",
            "criterions": [
                {
                    "exact_snippets": "Multidisciplinary tumor board decision",
                    "criterion": "tumor board decision",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "neoadjuvant treatment",
                    "criterion": "neoadjuvant treatment",
                    "requirements": [
                        {
                            "requirement_type": "decision",
                            "expected_value": "required"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor distance from the anal verge <15 cm based on endoscopy or magnetic resonance imaging",
            "criterions": [
                {
                    "exact_snippets": "Tumor distance from the anal verge <15 cm",
                    "criterion": "tumor distance from the anal verge",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": "<",
                                "value": 15,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient 18 to 80 years old",
            "criterions": [
                {
                    "exact_snippets": "Patient 18 to 80 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* General health condition status WHO 0-1",
            "criterions": [
                {
                    "exact_snippets": "General health condition status WHO 0-1",
                    "criterion": "general health condition status",
                    "requirements": [
                        {
                            "requirement_type": "WHO performance status",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "WHO"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "WHO"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absence of co-morbidities that may affect treatment",
            "criterions": [
                {
                    "exact_snippets": "Absence of co-morbidities that may affect treatment",
                    "criterion": "co-morbidities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "impact on treatment",
                            "expected_value": "may affect"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neutrophils >1,500 / mm3, platelets >100,000 / mm3, hemoglobin> 10 g / dL, normal creatinine, and creatinine clearance> 50 mL / min",
            "criterions": [
                {
                    "exact_snippets": "Neutrophils >1,500 / mm3",
                    "criterion": "neutrophils",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets >100,000 / mm3",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin> 10 g / dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "normal creatinine",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance> 50 mL / min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "rate",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed informed consent of the patient",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Distant metastases",
            "criterions": [
                {
                    "exact_snippets": "Distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-resectable cancer",
            "criterions": [
                {
                    "exact_snippets": "Non-resectable cancer",
                    "criterion": "cancer",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contraindications for the administration of chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Contraindications for the administration of chemotherapy",
                    "criterion": "contraindications for chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous pelvic radiotherapy or chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Previous pelvic radiotherapy",
                    "criterion": "pelvic radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous ... chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of inflammatory bowel disorders",
            "criterions": [
                {
                    "exact_snippets": "History of inflammatory bowel disorders",
                    "criterion": "inflammatory bowel disorders",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of angina, acute myocardial infarction or heart failure",
            "criterions": [
                {
                    "exact_snippets": "History of angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... acute myocardial infarction",
                    "criterion": "acute myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active sepsis or systemic infection",
            "criterions": [
                {
                    "exact_snippets": "Active sepsis",
                    "criterion": "sepsis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic infection",
                    "criterion": "systemic infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Untreated physical and mental disability",
            "criterions": [
                {
                    "exact_snippets": "Untreated physical ... disability",
                    "criterion": "physical disability",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "Untreated ... mental disability",
                    "criterion": "mental disability",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Synchronous malignancy",
            "criterions": [
                {
                    "exact_snippets": "Synchronous malignancy",
                    "criterion": "synchronous malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or breast-feeding",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breast-feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lack of compliance with the protocol process",
            "criterions": [
                {
                    "exact_snippets": "Lack of compliance with the protocol process",
                    "criterion": "compliance with the protocol process",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-granting of signed informed consent",
            "criterions": [
                {
                    "exact_snippets": "Non-granting of signed informed consent",
                    "criterion": "signed informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}