Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial

Inclusion Criteria: * Histologically confirmed rectal adenocarcinoma * cT3, cT4, threatened CRM / MRF, EMVI (+), ≥N1 * Multidisciplinary tumor board decision for neoadjuvant treatment * Tumor distance from the anal verge \<15 cm based on endoscopy or magnetic resonance imaging * Patient 18 to 80 years old * General health condition status WHO 0-1 * Absence of co-morbidities that may affect treatment * Neutrophils \>1,500 / mm3, platelets \>100,000 / mm3, hemoglobin\> 10 g / dL, normal creatinine, and creatinine clearance\> 50 mL / min * Signed informed consent of the patient Exclusion Criteria: * Distant metastases * Non-resectable cancer * Contraindications for the administration of chemotherapy * Previous pelvic radiotherapy or chemotherapy * History of inflammatory bowel disorders * History of angina, acute myocardial infarction or heart failure * Active sepsis or systemic infection * Untreated physical and mental disability * Synchronous malignancy * Pregnancy or breast-feeding * Lack of compliance with the protocol process * Non-granting of signed informed consent