Phase II Study Evaluating Safety of Non-Surgical Care After Chemoradiotherapy in Low Rectal Cancer Patients

What this Trial Is About

This research aims to evaluate the safety of non-operative management NOM for patients with low rectal cancer LRC who achieve a complete clinical response after chemoradiotherapy CRT. This Phase II study focuses on assessing whether avoiding surgery is as safe as surgery in controlling local tumor growth, by monitoring the rates of local tumor regrowth and positive resection margins when surgery is eventually needed. The study addresses the significant impact of surgery on bowel and sexual function and body image, seeking alternatives for patients who respond well to CRT. Patients who meet strict criteria for complete clinical response after CRTsuch as no palpable tumor, no residual tumor visible on endoscopy or MRI, no suspicious lymph nodes, and normal CEA levelswill enter the study. These participants will undergo active surveillance with regular clinical exams, endoscopy, pelvic MRI, blood tests for CEA levels, and chestabdomenpelvis CT scans at scheduled intervals over two years. The goal is to closely monitor for any local tumor regrowth or spread without immediate surgery. Throughout the study, participants will attend clinical visits for physical exams and imaging at defined time points every 3 to 24 months. The researchers will measure outcomes including the rate of local tumor regrowth, survival rates, disease-free survival, and quality of life aspects like bowel function. This ongoing monitoring will help determine if NOM is a safe alternative to surgery, potentially allowing patients to avoid the significant side effects of surgical removal of the rectum and anus. Total participation duration covers two years of active surveillance following CRT.

Non-operative Management for Locally Advanced Rectal Cancer