Circulating Tumor DNA Guided Adjuvant Chemotherapy for Colon Cancer: A Prospective, Multicenter, Open-label, Randomized Controlled Clinical Trial

What this Trial Is About

Researchers are investigating the use of circulating tumor DNA (ctDNA) to guide adjuvant chemotherapy decisions in patients with stage II high-risk or stage III colon cancer. This multicenter, open-label, randomized controlled trial aims to improve risk stratification beyond traditional pathological staging, as ctDNA presence after surgery may indicate a higher chance of cancer recurrence. The study explores whether ctDNA can help tailor chemotherapy duration and intensity without compromising patient outcomes. Participants are divided into high-risk and low-risk groups based on postoperative pathology. CtDNA is tested seven days after surgery. In the low-risk group, ctDNA-negative patients receive observation only, while ctDNA-positive patients are randomly assigned to receive either 3 months of Capeox chemotherapy or observation, with ctDNA retesting at 4 months. In the high-risk group, all patients receive 3 months of Capeox chemotherapy; afterward, ctDNA-negative patients undergo observation, while ctDNA-positive patients are randomized to receive either additional chemotherapy or second-line treatment as decided by their physician, with ctDNA retesting at 7 months. During the study, patients undergo repeated ctDNA testing to monitor treatment response and recurrence risk. Researchers will assess the 3-year disease-free survival rate as the primary outcome. Participants will be closely monitored for treatment effects and disease status throughout the study, which lasts several years. This approach aims to personalize chemotherapy plans based on molecular markers alongside traditional clinical staging.

Circulating Tumor DNA Guided Adjuvant Chemotherapy for Colon Cancer