Phase 3 Study Comparing Induction Chemotherapy Plus Chemoradiotherapy Versus Chemoradiotherapy Alone Before Surgery for Locally Recurrent Rectal Cancer

What this Trial Is About

Researchers are evaluating treatments for patients with locally recurrent rectal cancer in this multicenter, open-label, randomized phase III clinical trial. The study compares two approaches for neoadjuvant treatment before surgery induction chemotherapy followed by chemoradiotherapy and surgery versus chemoradiotherapy and surgery alone. The purpose is to determine whether adding induction chemotherapy improves surgical outcomes and cancer control. Participants will be randomly assigned to one of two groups. The experimental group receives induction chemotherapy using either CAPOX, FOLFOX, or FOLFIRI regimens, followed by chemoradiotherapy and then surgery. The control group receives chemoradiotherapy followed by surgery without induction chemotherapy. Radiotherapy doses vary based on prior treatment history, and surgery type depends on tumor location. Intraoperative radiotherapy is optional. During the study, patients will undergo MRI and clinical assessments to confirm resectability and monitor response to treatment. Researchers will assess the proportion of patients with clear surgical margins within one month of surgery, along with long-term outcomes such as survival and recurrence over five years. They will also evaluate treatment toxicity, compliance, surgical complications, radiological response, and quality of life at multiple time points. Follow-up includes monitoring up to five years after treatment to capture disease progression and survival.

Induction Chemotherapy for Locally Recurrent Rectal Cancer