Phase III Study Comparing Chemotherapy With or Without Targeted Therapy for Stage T3-4N2 Colorectal Cancer

What this Trial Is About

Researchers are comparing two treatment approaches for patients with resectable stage T3-4N2 colorectal cancer. The main goal is to see if combining targeted therapy with standard adjuvant chemotherapy improves disease-free survival compared to chemotherapy alone. This is a Phase III randomized clinical trial sponsored by the Sixth Affiliated Hospital, Sun Yat-sen University. Participants will be assigned to one of two groups one receiving adjuvant chemotherapy combined with targeted therapy, and the other receiving only adjuvant chemotherapy. Chemotherapy regimens include oxaliplatin-based CapeOx or FOLFOX, single-agent 5-FULV, or capecitabine. Targeted therapy, such as Bevacizumab or Cetuximab, is selected based on gene mutation status and is given alongside chemotherapy on specific schedules. During the study, participants will be monitored for outcomes including 3-year and 5-year disease-free survival, median disease-free survival, overall survival, and complications. The study involves long-term follow-up up to five years after surgery to thoroughly assess treatment effects and safety. Participants will undergo regular evaluations as part of this process to track their health and response to treatment.

Adjuvant Chemotherapy Combined With Targeted Therapy or Not in the T3-4N2 Colorectal Cancer Patients