Comparing Total Neoadjuvant Therapy and Watch-and-Wait to Surgery for Treating Rectal Cancer

What this Trial Is About

Researchers are evaluating whether a watch-and-wait approach can help about half of rectal cancer patients preserve their rectum after achieving a complete or near-complete clinical response to total neoadjuvant therapy TNT. The study compares complications, quality of life, and survival rates between patients who follow watch-and-wait after TNT and those who undergo surgery first. The trial also aims to find markers that predict treatment response and factors affecting survival after chemoradiotherapy CRT or TNT. The study has two parts. In the first, participants with specific stages of rectal cancer are randomized to receive either TNTwhich includes CRT followed by consolidation chemotherapyor initial surgery. Those in the TNT group are assessed 4 to 5 weeks after chemotherapy to see if they have a complete or near-complete response if so, they are monitored without surgery. Those without a response have surgery. The second part collects data from participants who have received CRT or TNT as part of routine care or who did not join the first part. Participants will undergo regular assessments including digital exams, MRI scans, rectoscopy, and biopsies to monitor response and side effects. The study measures complications, toxicity, mortality, quality of life, fatigue, and rectal preservation rates over up to three years, as well as survival outcomes for up to five years. Follow-up includes monitoring for tumor regrowth and long-term side effects, with the total participation duration varying by individual treatment paths.

Total Neoadjuvant Therapy and Organ Preservation Versus Surgery for Rectal Cancer.