Phase III trial of short-course radiotherapy followed by CAPOXIRI versus CAPOX in locally advanced rectal cancer: the ENSEMBLE trial.

ABSTRACT: The two key concerns in treating locally advanced rectal cancer (LARC) are as follows: (i) prolonging survival by reducing distant metastases and (ii) maintaining anorectal function and quality of life in surviving patients by safely avoiding rectal resection. To resolve these issues, in recent years, total neoadjuvant therapy (TNT), a preoperative combination of chemoradiotherapy or short-course radiotherapy (SCRT) and systemic chemotherapy, has been developed as a multidisciplinary treatment of LARC. There have been no prospective studies on consolidation triplet versus doublet regimens after SCRT. This randomized phase III trial (the ENSEMBLE trial) aims to test the superiority of consolidation irinotecan, capecitabine, and oxaliplatin over capecitabine and oxaliplatin after SCRT as TNT

SUBMITTER: Watanabe J 

PROVIDER: S-EPMC12836718 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature