NCT05179889RecruitingPhase 2/3
Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer
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
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
A multicenter, open labeled randomized, phase II trial comparing mFOLFIRINOX and mFOLFOX6 as adjuvant treatment for high risk stage III (pT4N1/2 or pTanyN2) colon cancer
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 308 (estimated)
- First submitted
- 17 Dec 2021
- Start date
- 6 Jul 2021
- Primary completion date
- 5 Jul 2028
- Lead sponsor
- Chungnam National University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT05179889
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 308
- From 6 Jul 2021 to the primary completion date, 5 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Middle or lower rectal cancer of need for radiotherapy
- Underlying disease or postoperative condition which is contraindication for chemotherapy
- Known hypersensitivity reaction to any study treatment component
- Familial adenomatosis polyposis or hereditary non-polyposis colorectal cancer
- Inflammatory bowel disease
- Previous other malignancy which cannot be curatively treated
Other
- Distant metastasis
- Postoperative complication of 3 or more grades of Clavien-Dindo classification
- Pregnancy or breast feeding
- Any other situation would exclude the patient from study based on the investigator's opinion
Who the study is looking for
- Age of 20-70 years with an ECOG ≤ 2
- Age of 71-75 years with an ECOG = 0
- Pathologically confirmed high-risk stage III colon adenocarcinoma (pT4N1 or pTanyN2)
- Curative radical resection (successful R0 resection) within 60 days before randomization
- 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)
- Able to understand and willing to sign and date written voluntary informed consent form
- Life expectancy ≥ 5 years
Age in the registry: 20 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.