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 (Jun 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
Treatments studied
Other
Cancer type
Colorectal Cancer
Disease stage
Required: Stage II, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT05534087 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior , disqualifies patients from enrollment.
What disease stage is eligible?
Stage II or III is required.
Is there an age limit?
Yes. Patients must be 75 years or younger and at least 19 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages