Phase II Study to Assess the Safety of Non-operative Management for Low Rectal Cancer

What this Trial Is About

Researchers are evaluating the safety of non-operative management (NOM) in patients with low rectal cancer (LRC) who achieve a complete clinical response after chemoradiotherapy (CRT). This Phase II study aims to assess whether avoiding surgery, which can cause significant long-term effects, is safe by monitoring local cancer regrowth and surgical margin status if surgery becomes necessary. The study addresses concerns about the safety of NOM due to limited available evidence and focuses on patients who respond well to CRT. Patients who achieve a complete clinical response based on specific criteria including physical exam, endoscopy, MRI, and blood tests will be offered participation. Those enrolled will undergo active surveillance with regular digital rectal exams, endoscopy, pelvic MRI, blood tests, and CT scans over two years to monitor for tumor regrowth or spread. The study will track recurrence rates, survival outcomes, and quality of life measures to evaluate NOM as a potential alternative to surgery. Participants will have scheduled assessments every 3 to 6 months including physical exams, imaging, and laboratory tests for 24 months. Researchers will measure local regrowth rates at 2 years as the primary outcome, along with survival and quality of life as secondary outcomes. This careful monitoring aims to determine if NOM can safely replace surgery for some patients, potentially improving bowel and sexual function and reducing treatment costs. Total participation lasts for two years of follow-up after CRT completion.

Non-operative Management for Locally Advanced Rectal Cancer