NCT07340567

Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test

Tailoring the Decision for Adjuvant Chemotherapy Using Circulating Tumour DNA, in Patients With Stage III Colorectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,450 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

CIRCULATE-III is an international, multicenter, open-label, randomized phase III trial designed to use ctDNA as a selection criterion for intensification or de-escalation of adjuvant chemotherapy. Eligible patients are randomly assigned to the following treatment groups: * Patients who test negative for ctDNA receive either capecitabine for 6 months (experimental group) or oxaliplatin + capecitabine for 3 months (standard group). * Patients who test positive for ctDNA receive either FOLFIRINOX for 6 months (experimental group) or FOLFOX for 6 months (standard group). Patient participation in the trial will not exceed 66 months after randomization, including a maximum treatment duration of 6 months and a follow-up period of 60 months.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine	De-escalation treatment (capecitabine \[CAPE\] for 6 months). Or Standard treatment (CAPOX for 3 months)
DRUG	Oxaliplatin	Standard treatment (CAPOX for 3 months)
DRUG	Folfirinox	Escalation treatment (5FU + irinotecan + oxaliplatin \[FOLFIRINOX\] for 6 months)
DRUG	FOLFOX regimen	Standard treatment (FOLFOX for 6 months)

Timeline

• Start date: 2026-05-01
• Primary completion: 2032-11-01
• Completion: 2035-11-01
• First posted: 2026-01-14
• Last updated: 2026-01-14

Locations

5 sites across 2 countries: France, Sweden