Blood test may decide who needs chemo after colon cancer surgery
NCT ID NCT04120701
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This trial investigates whether a blood test that detects tiny bits of tumor DNA (circulating tumor DNA) can help decide which patients with stage II colon cancer need chemotherapy after surgery. Patients whose blood test is positive for tumor DNA receive chemotherapy (mFOLFOX6), while those with a negative test are monitored. The goal is to see if this personalized approach improves disease-free survival and avoids unnecessary treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mFOLFOX6 (chemotherapy with 5-FU, leucovorin, and oxaliplatin)
- What this could lead to
- If successful, this approach could spare many patients unnecessary chemotherapy while ensuring those who need it receive it, improving survival and reducing side effects.
- What could go wrong
- The trial is large but still experimental; the ctDNA test may not reliably predict who benefits, and chemotherapy carries risks like nerve damage and fatigue.
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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 1,980 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2020
- Expected to finish
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Mar 2032
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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18 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: * Signed written informed consent obtained prior to any study specific procedures * Age ≥ 18 years and ≤ 75 years * Histologically confirmed stage II colon and high rectum adenocarcinoma excluding low and medium rectal cancers (tumor location ≥ 12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery are still eligible), without gross or microscopic evidence of residual disease after surgery with curative intent. Pathology report must be faxed to CRGA just after patient's randomization. * At least 12 lymph nodes analyzed * Patient with MSI + tumors can be included * All patients must have been discussed in multidisciplinary meetings with a decision of not performing adjuvant chemotherapy * No metastatic disease on CT-Scan and/or liver MRI done within 3 months before randomization. * Randomization planned up to 7 weeks after curative R0 resection * WHO performance Status \< 2 * No prior chemotherapy for colo-rectal cancer * No prior abdominal or pelvic irradiation for colo-rectal cancer * Life expectancy of ≥ 5 years * Adequate haematological function: with neutrophils ≥ 1,500 /mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL (5,6 mmol/l) * Total bilirubin ≤ 1.5 x ULN (upper limit of normal) * ASAT and ALAT ≤ 2.5 x ULN * Alkaline phosphatase ≤ 2.5 x ULN * Serum creatinine ≤ 120 µmol/L or creatinine clearance ≥50 ml/min according MDRD (Modification of Diet in Renal Disease) * Carcinoembryogenic antigen (CEA) ≤ 1.5 x ULN after surgery (during screening period) * Negative pregnancy test for registration(for women of childbearing age) * Patient affiliated to a social security system Exclusion Criteria: * T4b tumors * Peripheral neuropathy \> grade 1 * Comorbidity influencing the 5 year patients' survival including clinically relevant cardiovascular disease, * Ischemic myocardial infarction in the last year and/or unstable ischemic cardiopathy, * Participation to another interventional study for postoperative therapy * Partial or complete DPD deficiency * Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to sign the informed consent or to finish the study * Medical history of other concomitant or previous malignant disease, except adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer in complete remission for ≥ 5 years, * Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women. Women of childbearing potential should agree to use a method of contraception during treatment of the trial and at least 4 months after discontinuation of oxaliplatin therapy and at least 30 days after discontinuation of 5-fluorouracil. Men must agree to use a method of contraception during treatment and at least 6 months after stopping oxaliplatin therapy and at least 3 months after stopping 5-fluorouracil.
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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.
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The places running it
1 site. 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
Locations
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Fédération Francophone de Cancérologie Digestive
RECRUITINGDijon, 21000, France
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