Clinical Trial

Platform Study of Circulating Tumor DNA Directed Adjuvant Chemotherapy in Colon Cancer (KCSG CO22-12)

Study acronym: CLAUDIA
Recruiting Phase 3
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Summary
This study is a prospective, open-label, randomized phase 3 clinical trial. It aims to investigate if the early introduction of intensified chemotherapy (3 months of modified FOLFIRINOX) improves the 3-year disease-free survival rate compared to standard treatment (FOLFOX/CAPOX for an additional three months to complete six months of standard adjuvant chemotherapy) in patients with stage 2-3 colon cancer in whom ctDNA MRD in the part 1 study remained positive during adjuvant FOLFOX/CAPOX chemotherapy
Protocol Amendment History 1 change
notable Trial sites expanded: 3 -> 13 locations 2026-08-11
Trial Details
NCT Number NCT05534087
Lead Sponsor Seoul National University Hospital
Conditions Colon Cancer
Enrollment 236 participants
Start Date 2022-12-15
Primary Completion 2028-09-30 (estimated)
Study Completion 2030-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-10