drugset / Trial / NCT07340567

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

NCT07340567

Phase 3 Not yet recruiting 2450 enrolled UNICANCER Natera, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule
Subject Irinotecan Small molecule
Comparator Oxaliplatin Small molecule
Subject fluorouracil Small molecule

Indications