mFOLFIRINOX versus mFOLFOX as additional treatment for high-risk stage III colon cancer
Official title: mFOLFIRINOX Versus mFOLFOX 6 as Adjuvant Treatment for High Risk Stage III (pT4N1/2 or pTanyN2) Colon Cancer: Multicenter, Open Labeled, Randomized, Phase II Study
Run by Chungnam National University Hospital · NCT05179889 · Data updated 2026-11-12
This trial will test whether giving mFOLFIRINOX instead of mFOLFOX after surgery helps people with high-risk stage III colon cancer (pT4N1/2 or any pT with N2) stay cancer-free longer.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years to 75 Years |
| Sex | All |
| Enrollment | 308 (estimated) |
| Sponsor | Chungnam National University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Daejeon) |
| Status | Recruiting |
| Started | July 6, 2021 |
| Main results expected | July 5, 2028 |
| Study ends | March 15, 2031 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT05179889 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 20–75 with pathologically confirmed high-risk stage III colon cancer (pT4N1 or pTanyN2) who had an R0 resection within 60 days, meet ECOG and organ function criteria, and can give informed consent.
✕Probably not a fit
Patients with distant metastases, rectal cancer requiring radiotherapy, major postoperative complications, poor organ function, or an ECOG performance status beyond the allowed limits are unlikely to benefit from or be eligible for this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, open-label, randomized phase II/III trial that assigns patients 1:1 to receive either mFOLFIRINOX or mFOLFOX6 after curative (R0) resection. Eligible patients must have high-risk stage III colon adenocarcinoma (pT4N1 or pTanyN2) and meet age, performance status, and organ function requirements. Treatment begins within 60 days after surgery and patients are followed for outcomes such as recurrence and survival while monitored for toxicity. The trial compares a more intensive chemotherapy combination (mFOLFIRINOX) against the current mFOLFOX6 backbone to see if intensification reduces relapse in this higher-risk group.
Why it matters
Potential benefit: If successful, the intensified mFOLFIRINOX regimen could lower recurrence rates and improve disease-free survival for patients with high-risk stage III colon cancer.
How similar studies have gone: Intensified chemotherapy regimens have been explored in other settings but using FOLFIRINOX-like combinations as adjuvant therapy for high-risk stage III colon cancer is relatively novel with limited prior data and a known trade-off between potential benefit and increased toxicity.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age of 20-70 years with an ECOG ≤ 2 2. Age of 71-75 years with an ECOG = 0 3. Pathologically confirmed high-risk stage III colon adenocarcinoma (pT4N1 or pTanyN2) 4. Curative radical resection (successful R0 resection) within 60 days before randomization 5. Adequate organ functions * ANC ≥ 2×106 cells/mL * Hemoglobin ≥ 9.0 g/dL * Platelets ≥ 100×106 cells/mL * Alanine aminotransferase/aspartate aminotransferase ≤2.5 × times the upper limit of normal (ULN) * Serum total bilirubin ≤ 1.5 ULN * Alkaline phosphatase ≤ 2.5 × ULN * Serum creatinine ≤1.5 × ULN or creatinine clearance \> 50 mL/min (Cockcroft-Gault formula) 6. Able to understand and willing to sign and date written voluntary informed consent form 7. Life expectancy ≥ 5 years Exclusion Criteria: 1. Distant metastasis 2. Middle or lower rectal cancer of need for radiotherapy 3. Postoperative complication of 3 or more grades of Clavien-Dindo classification 4. Underlying disease or postoperative condition which is contraindication for chemotherapy 5. Known hypersensitivity reaction to any study treatment component 6. Familial adenomatosis polyposis or hereditary non-polyposis colorectal cancer 7. Inflammatory bowel disease 8. Previous other malignancy which cannot be curatively treated 9. Pregnancy or breast feeding 10. Any other situation would exclude the patient from study based on the investigator's opinion
Where it's running
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Chungnam National University Hospital
Daejeon, South Korea Recruiting
Study contacts
- Principal investigator: Kyung Ha Lee — Chungnam National University Hospital
- Study coordinator: Kyung Ha Lee
- Email: lllllkh@cnuh.co.kr
- Phone: 821042141415
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.