Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test
Condition(s) studied
Investigational drug(s) / intervention(s)
Capecitabine: De-escalation treatment (capecitabine \[CAPE\] for 6 months). Or Standard treatment (CAPOX for 3 months)
Oxaliplatin: Standard treatment (CAPOX for 3 months)
Folfirinox: Escalation treatment (5FU + irinotecan + oxaliplatin \[FOLFIRINOX\] for 6 months)
FOLFOX regimen: Standard treatment (FOLFOX for 6 months)
Study 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.
Eligibility
Primary outcome measure(s)
- Non-inferiority of 6-month CAPE vs 3-month CAPOX ACT in terms of 3-year Disease Free Survival ctDNA-negative cohort — DFS will be defined as time from date of randomization until the date of first documented recurrence local or metastatic, date of second colorectal cancer, or date of death from any cause wichever came first, assessed up to 42 months.
ctDNA-negative cohort: The primary objective is to evaluate the non-inferiority of 6-month capecitabine alone (CAPE; de-escalation strategy) compared to 3-month capecitabine + oxaliplatin (CAPOX; standard therapy) in terms of 3-year disease-free survival (DFS) as adjuvant chemotherapy (ACT) protocol in stage III pMMR/MSS CRC patients with post-operative ctDNA-negative. - Superiority of 6-month FOLFIRINOX vs 6-month FOLFOX ACT in terms of 3-year Disease Free Survival ctDNA-positive cohort — DFS will be defined as time from date of randomization until the date of first documented recurrence local or metastatic, date of second colorectal cancer, or date of death from any cause, wichever came first, assessed up to 42 months.
ctDNA-positive cohort: The primary objective is to evaluate the superiority of 6-month FOLFIRINOX (escalation strategy) compared to 6-month FOLFOX (standard therapy) in terms of 3-year DFS as an ACT protocol in stage III pMMR/MSS CRC patients with post-operative ctDNA-positive.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Institut Gustave Roussy | Villejuif | France | |
| Sahlgrenska University Hospital | Gothenburg | Sweden | |
| Skäne University Hospital | Lund | Sweden | |
| Södersjukhuset | Stockholm | Sweden | |
| Onkologikliniken | Uppsala | Sweden |
More UNICANCER trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07340567 on ClinicalTrials.gov ↗ ← All trials in France