Evaluating Adjuvant Chemotherapy Versus Observation in Locally Advanced Colorectal Cancer After Preoperative Treatment with Pathologic Stage pT0-3N0M0

What this Trial Is About

Colorectal cancer is one of the most common and deadly cancers worldwide, often diagnosed at a locally advanced stage. This study investigates whether patients with clinical local advanced colorectal cancer cTxN1-2M0 who have undergone preoperative chemotherapy or chemoradiotherapy and are pathologically diagnosed with stage pT0-3N0M0 actually need adjuvant chemotherapy. The effectiveness and safety of adjuvant chemotherapy in this group remain unclear, motivating this research to compare outcomes with and without such treatment. Participants are randomly assigned to one of two groups one group receives adjuvant chemotherapy for 6 to 8 cycles after surgery, while the other group follows a watchful waiting approach without additional chemotherapy. The study focuses on patients whose cancer has down-staged following preoperative therapies and surgery. The primary goal is to assess disease-free survival over three years, with secondary goals including overall survival, treatment side effects, remission rates, and surgery-related complications. Throughout the study, participants undergo regular monitoring to track their health status and treatment effects. Researchers will collect data on survival, adverse reactions to therapies, and complications occurring within 30 days after surgery. The total study period extends up to 11 years, allowing for long-term follow-up of outcomes to better understand the benefits and risks of adjuvant chemotherapy in this patient population.

Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis