Clinical trial · Interventional
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
NCT05179889CI-TRIAL-00106015recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer Stage III | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mFOLFIRINOX | Drug | — | UNRESOLVED |
| mFOLFOX 6 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- mFOLFIRINOX
- interventionNames
- Drug: mFOLFIRINOX
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- mFOLFOX 6
- interventionNames
- Drug: mFOLFOX 6
Primary outcomes (1)
- measure
- Disease free survival (DFS)
- timeFrame
- 3 years after the operation
- description
- the time from the date of operation to the date of the first recurrence or the death from any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLee KH, Yang IJ, Ha GW, Lee J, Park YY, Lee SH, Lee JM, Bae JH, Park EJ, Kim H, Kim KY, An S, Kim IY, Kim JY. mFOLFIRINOX versus mFOLFOX 6 as adjuvant treatment for high-risk stage III colon cancer - the FROST trial: study protocol for a multicenter, randomized controlled, phase II trial. BMC Cancer. 2024 Mar 29;24(1):397. doi: 10.1186/s12885-024-11939-x. PMID 38553680