Total Neoadjuvant Therapy in Rectal Cancer

In this phase 2 study, the efficacy of total neoadjuvant therapy in Taiwanese patients with rectal cancer will be investigated. Patients with stage II or III middle/low rectal cancer will be prospective enrolled. The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered. The primary endpoint is the complete response (CR) rate which will take into account the patients with clinical and pathological complete response.

NCT Number	NCT06162650
Lead Sponsor	National Cheng-Kung University Hospital
Conditions	Rectal Cancer
Enrollment	42 participants
Start Date	2023-11-16
Primary Completion	2026-11-16 (estimated)
Study Completion	2030-11-16 (estimated)
Updated on ClinicalTrials.gov	2026-04-08