Rationale and design of REGINA, a phase II trial of neoadjuvant regorafenib, nivolumab, and short-course radiotherapy in stage II and III rectal cancer
Giacomo Bregni, Caroline Vandeputte, Andrea Pretta, Chiara Senti, Elena Trevisi, Elena Acedo Reina, Pashalina Kehagias, Gabriel Liberale, Luigi Moretti, Maria Antonietta Bali, Pieter Demetter, Patrick Flamen, Javier Carrasco, Lionel D’Hondt, Karen Geboes, Yeter Gökburun, Marc Peeters, Marc Van den Eynde, Jean‐Luc Van Laethem, Philippe Vergauwe, Camille Anastasia Chapot, Marc Buyse, Amélie Deleporte, Alain Hendlisz, Francesco Sclafani
Abstract
INTRODUCTIION : Standard treatment for stage II and III rectal cancer has long consisted of neoadjuvant long-course chemoradiotherapy (CRT) or short-course radiotherapy (SCRT) followed by total mesorectal excision (TME) plus or minus adjuvant chemotherapy. Recently, results from the RAPIDO and PRODIGE-23 trials suggested superiority of the ‘total neoadjuvant therapy’ approach (i.e., systemic chemotherapy delivered before or after pre-operative (C)RT) over standard treatment in terms of pathological complete response (pCR), and disease-related treatment failure and disease-free survival, respectively [...].