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Can a chemo boost outsmart lingering colon cancer cells?

NCT ID NCT05534087

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This trial is testing whether giving a stronger chemotherapy regimen (mFOLFIRINOX) early can improve outcomes for people with stage II-III colon cancer who still have signs of cancer DNA in their blood during standard adjuvant chemo. Participants are randomly assigned to either receive the intensified treatment or continue with standard chemo. The goal is to see if the intensified approach can reduce the chance of cancer returning or spreading.

What this could mean

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

Active substance
Intensified chemotherapy with modified FOLFIRINOX regimen
What this could lead to
If successful, this approach could offer a more effective treatment strategy for colon cancer patients at high risk of recurrence, potentially improving their chances of staying cancer-free.
What could go wrong
The intensified regimen may cause more side effects, and it's uncertain whether it will improve survival compared to standard treatment. The trial is still ongoing, and results are not yet available.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 236 people

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

Started

Dec 2022

Expected to finish

Sep 2030

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

19 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. Patients who willingly consented and signed the informed consent form to participate in the study 2. Age range of 19 to 75 years 3. Adenocarcinoma of colon confirmed by histology 4. Patients with stage II-III colon cancer as defined by the American Joint Committee on Cancer's eighth edition (Stage II cancer is limited to patients who are at a high risk, with more than one risk factor for recurrence.) 5. Patients who have completed the sixth cycle of FOLFOX or the fourth cycle of CAPOX adjuvant chemotherapy for colon cancer following radical resection (R0 resection) 6. A ctDNA test performed 3 to 6 weeks after surgery reveals a positive MRD 7. ECOG performance scale of 0-1 (only 1 is allowed for 70-75 years old) 8. Adequate bone marrow function \[ANC ≥1,300/LL, platelets ≥75,000/LL, hemoglobin ≥8.0g/dL (may be eligible in study if intermittent transfusion is required)\] 9. Appropriate liver function (total bilirubin ≤1.5xULN, AST and ALT ≤3xULN) 10. Appropriate renal function (serum creatine ≤1.5xULN, renal clearance rate ≥50 ml/min) 11. Patients who are deemed to understand the study protocol and are willing to participate in the trial until it is completed Exclusion Criteria: 1. Pregnant or lactating women 2. Pregnant women who had a positive pregnancy test at the time of the baseline examination (postmenopausal women must be amenable for at least 12 months to be considered non-fertility) 3. Sexually active men and women of reproductive age who are unwilling to use contraception throughout the study treatment and for a period of 6 months (female) or 3 months (male) following the discontinuation of study treatment 4. Clinically significant heart condition \[unstable angina requiring medication, symptomatic coronary artery disease, congestive heart failure, or significant heart arrhythmia above NYHA II, or acute coronary syndrome, including myocardial infarction within the last 6 months\] 5. Active viral infections such as HIV (However, HBV carriers may enroll if their HBV DNA titer is less than 20,000 IU/ml, and antiviral drugs for hepatitis B may be administered prophylactically at the investigator's discretion) 6. Significant uncontrolled infections or other uncontrolled comorbidities 7. Symptomatic inflammatory bowel disease 8. Allogeneic transplantation history necessitating immunosuppressive therapy 9. A history of other malignancies identified within the last three years, except for completed removed basal cell carcinoma of the skin, completely removed cervical epithelial carcinoma, and thyroid cancer that has been treated, including surgery 10. Recurrent or residual disease identified clinically or radiographically 11. Previous history of irinotecan treatment 12. Polyposis including familial adenomatous polyps 13. Two or more colon or rectal cancers with a pathologic stage greater than II that were detected concurrently or within the last three years 14. When the investigator determines that the subjects' safety may be jeopardized during the study because of other serious or unstable pre-existing medical or mental conditions 15. Prior clinical trial participation and usage of investigational drugs or devices following radical resection of colon cancer 16. Patients with peripheral neuropathy who have a CTCAE v5 grade 3 or higher functional disability (corresponds to "severe symptoms, limiting self-care activity of daily living" according to CTCAE v5 criteria) 17. Previous anaphylactic reaction or severe and unexpected reactions to fluoropyrimidines or platinum 18. Gilbert's syndrome, dehydro-pyridine dehydrogenase (DPD) deficiency, or homozygous UGT1A1\*28 alleles

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Ajou University Hospital

    RECRUITING

    Suwon, South Korea

  • Asan Medical Center

    RECRUITING

    Seoul, South Korea

  • Chonnam National University Hwasun Hospital

    RECRUITING

    Hwasun, South Korea

  • Chung-Ang University Hospital

    RECRUITING

    Seoul, South Korea

    Contact Email: •••••@•••••

  • Dong-A University Hospital

    RECRUITING

    Busan, South Korea

  • Korea University Guro Hospital

    RECRUITING

    Seoul, South Korea

  • Kyungpook National University Chilgok Hospital

    RECRUITING

    Daegu, South Korea

  • National Cancer Center

    RECRUITING

    Goyang, South Korea

  • SMG-SNU Boramae Medical Center

    RECRUITING

    Seoul, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, South Korea

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