NCT05179889 Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer
| NCT ID | NCT05179889 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Chungnam National University Hospital |
| Condition | Colon Cancer Stage III |
| Study Type | INTERVENTIONAL |
| Enrollment | 308 participants |
| Start Date | 2021-07-06 |
| Primary Completion | 2028-07-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 308 participants in total. It began in 2021-07-06 with a primary completion date of 2028-07-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Kyung Ha Lee
PRINCIPAL INVESTIGATOR
Chungnam National University Hospital
Frequently Asked Questions
Who can join the NCT05179889 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 75 Years, studying Colon Cancer Stage III. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05179889 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05179889 currently recruiting?
Yes, NCT05179889 is actively recruiting participants. Contact the research team at lllllkh@cnuh.co.kr for enrollment information.
Where is the NCT05179889 trial being conducted?
This trial is being conducted at Daejeon, South Korea.
Who is sponsoring the NCT05179889 clinical trial?
NCT05179889 is sponsored by Chungnam National University Hospital. The principal investigator is Kyung Ha Lee at Chungnam National University Hospital. The trial plans to enroll 308 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.