Nordic Non-Operative Management Study for Rectal Cancer with Complete Response to Pre-Treatment

What this Trial Is About

Researchers are evaluating the outcomes of a nonoperative management approach for rectal cancer in patients who have a complete clinical response after neoadjuvant therapy. This prospective, non-randomized, single-arm international trial aims to establish a unified protocol and compare the oncological results and organ preservation rates with practices worldwide. The study focuses on disease-free survival two years after starting nonoperative management as the primary endpoint. Patients with confirmed complete clinical response after standard neoadjuvant treatment undergo nonoperative surveillance involving clinical examinations, laboratory tests, and imaging such as digital rectal exams, endoscopy, rectal MRI, and body CT scans. This single treatment arm follows a watch-and-wait approach to monitor for local regrowth or distant spread, avoiding surgery unless cancer recurs. Follow-up visits occur every three months for the first two years and every six months for the next three years. Participants will be closely monitored through clinical assessments and imaging to detect any recurrence or metastases. Researchers will measure survival outcomes, organ preservation rates, quality of life, and treatment-related complications up to five years. Data are collected securely and pseudonymously, with costs of follow-up covered by the healthcare system. The study may end at a center if local recurrence exceeds 30% after complete clinical response.

Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer