NCT06167967

Circulating Tumor DNA Methylation Guiding Postoperative Adjuvant Chemotherapy in Stage III Colorectal Cancer

Circulating Tumor DNA Methylation Guiding Postoperative Adjuvant Chemotherapy in Stage III Colorectal Cancer: a Multicenter, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 990 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized controlled trial is to investigate whether ctDNA methylation is a more precise indicator to guide postoperative adjuvant chemotherapy in stage Ill colorectal cancer. The main questions it aims to answer are: 1. Whether ctDNA methylation-guided escalation strategy is superior to standard treatment for stage III high-risk CRC patients. 2. Whether ctDNA methylation-guided de-escalation strategy is non-inferior to standard treatment for stage III low-risk CRC patients. 325 cases were included in the high-risk cohort (T4 and/or N2) and 665 cases were included in the low-risk cohort (T1-T3, N1). Then patients in each cohort were randomly assigned to ctDNA-guided treatment (ctDNA-guided group) and standard treatment (standard treatment group) in a ratio of 2:1. The standard treatment group and ctDNA-negative group in the high-risk cohort were treated with XELOX regimen for 6 months, and the ctDNA-positive group in the high-risk cohort was treated with cmFOLFOXIRI regimen for 6 months. The standard treatment group and the ctDNA-positive group in the low-risk cohort were treated with XELOX regimen for 3 months, while the ctDNA-negative group in the low-risk cohort did not receive adjuvant chemotherapy.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ctDNA methylation	A blood-based circulating tumor DNA methylation assay that uses 6 different methylation markers, SEPT9 region1, SEPT9 region2, BCAT1, IKZF1, BCAN and VAV3.
DIAGNOSTIC_TEST	standard treatment	This group was treated according to standard procedure

Timeline

• Start date: 2024-04-08
• Primary completion: 2026-12-31
• Completion: 2029-12-31
• First posted: 2023-12-13
• Last updated: 2024-05-17

Locations

1 site across 1 country: China