Comparing Treatment Efficacy in Clinical Local Advanced Colorectal Cancer Following Preoperational Adjuvant Therapies and Pathologically Confirmed Stage I (pT0-3N0M0) With or Without Adjuvant Chemotherapy

What this Trial Is About

This research evaluates the need for adjuvant chemotherapy in patients with clinical local advanced colorectal cancer (cTxN1-2M0) who, after preoperational chemotherapy or chemoradiotherapy, are pathologically diagnosed as pT0-3N0M0 without high risk factors for recurrence. While adjuvant chemotherapy is known to be unnecessary in pathological stage I colorectal cancer after surgery, its benefit following preoperational treatments in this specific group remains unclear due to possible down-staging effects or false-positive lymph node diagnoses. Participants are randomly assigned to one of two groups: the control group receives 6 to 8 cycles of adjuvant chemotherapy after surgery, while the experimental group follows a watchful waiting approach without adjuvant chemotherapy. Both groups consist of patients who had clinical local advanced colorectal cancer treated preoperatively and confirmed as pathological stage I (pT0-3N0M0) post-surgery. Throughout the study, researchers monitor disease-free survival over three years as the primary outcome. Secondary outcomes include overall survival over five years, chemotherapy side effects, remission rates at one year, and post-surgery complications and death rates within 30 days. Participants will undergo regular assessments to evaluate these outcomes, supporting a comprehensive understanding of long-term treatment effects and safety.

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