Phase III Trial Comparing Surgery Plus Chemotherapy Versus Preoperative Chemoradiotherapy Followed by Surgery Plus Chemotherapy for Locally Recurrent Rectal Cancer

What this Trial Is About

Researchers are evaluating treatments for patients with locally recurrent rectal cancer who have not received prior pelvic radiation. This randomized phase III trial compares the outcomes of two treatment approaches surgery plus adjuvant chemotherapy alone versus preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy. The study aims to confirm whether adding preoperative chemoradiotherapy improves local relapse-free survival, with additional measures including overall survival, relapse rates, surgery success, and quality of life. Participants are randomly assigned to one of two groups. One group receives preoperative chemoradiotherapy using capecitabine and radiotherapy, followed by surgery and adjuvant chemotherapy, which may include CAPOX, mFOLFOX6, capecitabine, or 5-FU with leucovorin. The other group undergoes surgery followed by the same options for adjuvant chemotherapy. Surgical procedures are performed to achieve complete tumor removal, with timing depending on the assigned treatment arm. During the study, patients will be monitored at several points including before surgery, after surgery, and up to three years post-registration. Researchers will assess local relapse-free survival, overall survival, relapse-free survival, adverse events, and quality of life. Treatment completion rates and pathological responses to preoperative chemoradiotherapy will also be evaluated. The total duration of follow-up for participants extends through three years after registration to monitor long-term outcomes.

Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer