Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial
The purpose of this protocol is to compare neoadjuvant chemoradiation plus consolidation chemotherapy before surgical resection with the standard neoadjuvant chemoradiation followed by surgical resection and adjuvant chemotherapy in patients with rectal cancer.
• 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