Adjuvant Chemotherapy to Prevent Recurrence in Adults With High-Risk Rectal Cancer Using Detectable Circulating Tumor DNA After Surgery

What this Trial Is About

Researchers are studying whether adjuvant chemotherapy can prevent disease recurrence in adults with high-risk rectal cancer who have detectable circulating tumor DNA ctDNA after surgery. The study aims to determine if this chemotherapy improves disease-free survival compared to standard care. Rectal cancer remains a significant cause of mortality, and while current treatments reduce local recurrence, distant recurrence rates stay high. Identifying patients with residual disease through ctDNA may help target those who might benefit from additional chemotherapy. Participants with detectable ctDNA after surgery will be randomly assigned to receive either standard care or adjuvant chemotherapy consisting of 6 cycles of FOLFOX 5FUfolinic acid and oxaliplatin every 2 weeks or 4 cycles of CAPOX capecitabine and oxaliplatin within 8 to 12 weeks after surgery. The chemotherapy treatment lasts about 3 months. The study is conducted within a prospective colorectal cancer cohort using a randomized controlled design. During the study, participants will have blood samples taken and visits with their physicians before each chemotherapy cycle if assigned to treatment. Researchers will monitor disease-free survival, overall survival, and quality of life using questionnaires over several years. They will also assess the clearance of ctDNA after chemotherapy and study its presence at recurrence. The total follow-up includes up to 2 years for disease recurrence and up to 5 years for survival outcomes.

ctDNA-Based Adjuvant Chemotherapy for High-Risk Rectal Cancer