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

NCT07340567 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2450

Last updated 2026-01-14

No results posted yet for this 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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Natera, Inc.

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2032-11-01
Completion
2035-11-01

Countries

  • France
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07340567 on ClinicalTrials.gov