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New chemo cocktail aims to stop colon Cancer's return

NCT ID NCT05179889

Disease control Sponsor: Chungnam National University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial compares two chemotherapy combinations after surgery for people with high-risk stage III colon cancer. About 308 participants will receive either mFOLFIRINOX or the standard mFOLFOX6 for 12 cycles. The goal is to see if the stronger combo delays cancer recurrence and improves survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
chemotherapy (irinotecan, oxaliplatin, leucovorin, 5-FU)
What this could lead to
If successful, this could show that a stronger chemo combo (mFOLFIRINOX) helps prevent colon cancer from coming back after surgery better than the current standard.
What could go wrong
This is a mid-stage trial, so results are not yet proven. The stronger chemo may cause more side effects, and it may not improve survival or recurrence rates.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 308 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colon adenocarcinoma colonic neoplasm malignant colon neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colon cancer stage III

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chungnam National University Hospital

    RECRUITING

    Daejeon, 34112, South Korea

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