Preoperative Sequential Short-course Radiation Therapy and FOLFOX for Locally Advanced Rectal Cancer

The treatment protocol proposed in this study is to perform short-term radiation therapy and 4 cycles of FOLFOX chemotherapy for neoadjuvant treatment of locally advanced rectal cancer. Compared to conventional chemoradiation therapy, the preoperative radiotherapy period is shortened, and the cure rate of rectal cancer patients can be improved by early treatment of micrometastasis using systemic chemotherapy. The patients who are assigned to the study group will received the short-course radiotherapy and 4 cycles of FOLFOX and patients in the control will received conventional chemoradiotherapy for preoperative treatment. All patients are recommended to receive total mesorectal excision (TME) after neoadjuvant treatment and adjuvant chemotherapy will be given according to the pathological stage.

NCT Number	NCT05673772
Lead Sponsor	Kyungpook National University Hospital Collaborators: National Cancer Center, Korea
Conditions	Rectal Cancer
Enrollment	364 participants
Start Date	2020-10-23
Primary Completion	2028-12-28 (estimated)
Study Completion	2031-12-28 (estimated)
Updated on ClinicalTrials.gov	2026-02-12