Comparing TAS-102 and Capecitabine with Radiotherapy Before Surgery in Patients with Locally Advanced Rectal Cancer A Multi-center Phase III Trial

What this Trial Is About

Researchers are conducting a multicenter, randomized, phase III trial to assess a new treatment approach for locally advanced rectal cancer LARC. The study compares neoadjuvant chemoradiotherapy using a standard oral drug, capecitabine, with a newer oral formulation called TAS-102 combined with radiotherapy. This research aims to improve the rate of complete tumor response before surgery, as current treatments have limited success in achieving full tumor disappearance. The trial involves two groups receiving long-course radiotherapy alongside chemotherapy. One group receives TAS-102 at specific doses during radiotherapy weeks and additional chemotherapy cycles with oxaliplatin and TAS-102 before surgery. The other group receives capecitabine during radiotherapy and chemotherapy cycles with oxaliplatin and capecitabine before surgery. Surgery follows total mesorectal excision principles, and postoperative adjuvant therapy includes two cycles of CapeOX chemotherapy. Participants will be monitored for tumor response, side effects, and survival outcomes over several years. Key assessments include measuring complete response rate at one year, tracking severe adverse reactions, and evaluating recurrence-free and overall survival at three years. The study includes thorough imaging, clinical evaluations, and laboratory tests to assess treatment effects and safety, with participation lasting throughout treatment and follow-up periods.

Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial