OncoMatch/Clinical Trials/NCT05534087
Platform Study of Circulating Tumor DNA Directed Adjuvant Chemotherapy in Colon Cancer (KCSG CO22-12)
Is NCT05534087 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including mFOLFIRINOX-FOLFIRI intensified chemotherapy and FOLFOX or CAPOX adjuvant chemotherapy for colon cancer.
Treatment: mFOLFIRINOX-FOLFIRI intensified chemotherapy · FOLFOX or CAPOX adjuvant chemotherapy — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage II, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy (FOLFOX, CAPOX) — adjuvant
Patients who have completed the sixth cycle of FOLFOX or the fourth cycle of CAPOX adjuvant chemotherapy for colon cancer following radical resection (R0 resection)
Cannot have received: (irinotecan)
Previous history of irinotecan treatment
Cannot have received:
Prior clinical trial participation and usage of investigational drugs or devices following radical resection of colon cancer
Lab requirements
Blood counts
anc ≥1,300/ll, platelets ≥75,000/ll, hemoglobin ≥8.0g/dl (may be eligible in study if intermittent transfusion is required)
Kidney function
serum creatine ≤1.5xuln, renal clearance rate ≥50 ml/min
Liver function
total bilirubin ≤1.5xuln, ast and alt ≤3xuln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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