Can a chemo boost outsmart lingering colon cancer cells?
NCT ID NCT05534087
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 236 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2022
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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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
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19 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
13 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
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Ajou University Hospital
RECRUITINGSuwon, South Korea
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Asan Medical Center
RECRUITINGSeoul, South Korea
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Chonnam National University Hwasun Hospital
RECRUITINGHwasun, South Korea
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Chung-Ang University Hospital
RECRUITINGSeoul, South Korea
Contact Email: •••••@•••••
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Dong-A University Hospital
RECRUITINGBusan, South Korea
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Korea University Guro Hospital
RECRUITINGSeoul, South Korea
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Kyungpook National University Chilgok Hospital
RECRUITINGDaegu, South Korea
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National Cancer Center
RECRUITINGGoyang, South Korea
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SMG-SNU Boramae Medical Center
RECRUITINGSeoul, South Korea
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Samsung Medical Center
RECRUITINGSeoul, South Korea
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Seoul National University Bundang Hospital
RECRUITINGSeongnam, South Korea
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Seoul National University Hospital
RECRUITINGSeoul, South Korea
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Severance Hospital
RECRUITINGSeoul, South Korea
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