Recruiting nowPhase 3Randomised
What this trial is trying to do
After surgery for high-risk stage III colon cancer, the trial asks whether adjuvant mFOLFIRINOX—fluorouracil, oxaliplatin and irinotecan—can remove more remaining cancer cells than mFOLFOX6, which uses fluorouracil and oxaliplatin. Patients are randomly assigned to one regimen or the other.
The researchers expect the additional chemotherapy drug in mFOLFIRINOX might keep the cancer from returning for longer than mFOLFOX6. The main measure is disease-free survival, meaning the time before a recurrence or death, rather than overall survival.
Worth knowing: This is a relatively small phase 3 trial restricted to people with high-risk stage III disease, and its main outcome is disease-free survival rather than survival itself.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT05179889 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 308 people (planned) |
| Who can join | aged 20 Years to 75 Years |
| Run by | Chungnam National University Hospital |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug mFOLFIRINOX
- Drug mFOLFOX 6
What it is measuring
Disease free survival (DFS)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 3. Compares the treatment against current standard care in a large group. This is the design that changes practice.
How the researchers describe it
After inclusion and exclusion criteria have been fulfilled and the patient consent has been obtained, the patient will be included and randomized to mFOLFIRINOX or mFOLFOX 6 with a 1:1 ratio.
Arm A: mFOLFIRINOX Arm B: mFOLFOX
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Locally advanced
- Colon
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: South Korea.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT05179889, registered by Chungnam National University Hospital on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.