Short-course Radiotherapy or Long-course Chemoradiation Followed by mFOLFOXIRI Consolidation Chemotherapy for Organ Preservation in Low Rectal Cancer

Given the growing focus on preserving organ function and the utilization of neoadjuvant therapy, it is important to investigate and enhance the application of comprehensive neoadjuvant therapy in low rectal cancer. This approach aims to minimize or circumvent the organ dysfunction and subsequent decline in quality of life associated with radical surgery, with improving disease-free survival (DFS), while . Consequently, we propose to initiate a multicenter clinical trial to examine the medium- and long-term effectiveness of complete neoadjuvant therapy (comprising either short-course radiotherapy or long-course chemoradiation, followed by consolidation chemotherapy with mFOLFOXIRI) in increasing organ preservation rates in patients with low rectal cancer.

NCT Number	NCT06417476
Lead Sponsor	Pei-Rong Ding Collaborators: Yunnan Cancer Hospital, Liaoning Cancer Hospital & Institute, Shantou Central Hospital, Fujian Cancer Hospital, Jiangsu Provincial People's Hospital
Conditions	Rectal Neoplasms
Enrollment	66 participants
Start Date	2022-12-12
Primary Completion	2025-09-30 (estimated)
Study Completion	2026-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-13