drugset / Trial / NCT07340567
Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Irinotecan | Small molecule | — | — |
| Comparator | Oxaliplatin | Small molecule | — | — |
| Subject | fluorouracil | Small molecule | — | — |