Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer A Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating treatments for locally advanced rectal cancer to compare the current standard approach of neoadjuvant chemoradiation followed by surgery and adjuvant chemotherapy with a new strategy that adds consolidation chemotherapy before surgery. The goal is to improve disease control and survival while reducing treatment delays and complications associated with postoperative chemotherapy. This randomized controlled trial addresses concerns about the safety and effectiveness of total neoadjuvant therapy and aims to clarify benefits while keeping treatment schemes consistent. Participants are assigned to one of two groups. The experimental group receives a 5-week standard neoadjuvant chemoradiotherapy, followed by consolidation chemotherapy during the waiting period before surgery, with MRI re-staging at 6 weeks to determine response. Those who do not respond proceed immediately to surgery, while responders continue chemotherapy until surgery at 12 weeks. The control group receives the same chemoradiotherapy followed by surgery timed by MRI response and then adjuvant chemotherapy. Chemotherapy regimens include CAPOX or FOLFOX protocols. Throughout the study, participants undergo regular MRI scans to assess tumor response and receive detailed monitoring of treatment effects and side effects. Researchers measure disease-free survival over three years, complete pathological response, postoperative complications, hospital stay length, readmissions, negative resection margins, overall survival, chemotherapy toxicity, local recurrence, and treatment compliance. The total study duration extends up to three years postoperatively with ongoing evaluations to understand long-term outcomes.

Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial