drugset / Trial / NCT06197425

Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer

NCT06197425

Phase 3 Recruiting 1660 enrolled Centre Hospitalier Universitaire Dijon
RandomizedParallel-groupOpen-labelTreatment

Summary

Phase III multicentric, open-label, randomized study The main objective is to assess the efficacy on time to disease recurrence (TTR) of treating minimal residual disease diagnosed by the presence of ctDNA after full treatment (surgery + chemotherapy) in stage III or high-risk stage II colon or upper rectum adenocarcinoma

Timeline

Start
2026-05-07
Primary completion
2032-05
Completion
2032-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 180 mg/m2
Subject TAS-102 Small molecule 35 mg/m2
Subject fluorouracil Small molecule 400 mg/m2
Subject fluorouracil Small molecule 2400 mg/m2
Subject leucovorine Unknown 400 mg/m2