Using circulating tumor DNA to guide treatment decisions in stage II colon cancer
Official title: CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II
Run by Centre Hospitalier Universitaire Dijon · NCT04120701 · Data updated 2026-11-12
This study is testing if using a blood test that checks for tumor DNA can help doctors decide the best follow-up treatment for patients who have had surgery for stage II colon cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 1980 (estimated) |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Dijon) |
| Status | Recruiting |
| Started | January 17, 2020 |
| Main results expected | March 2032 |
| Study ends | March 2032 |
| Registry record updated | July 10, 2026 |
| Trial ID | NCT04120701 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 with histologically confirmed stage II colon cancer who have undergone curative surgery and have no evidence of residual disease.
✕Probably not a fit
Patients with metastatic disease or those who have previously received chemotherapy for colorectal cancer may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial aims to enhance post-surgical care for patients with resected stage II colon cancer by utilizing circulating tumor DNA as a novel biomarker. The study will assess whether this biomarker can inform decisions regarding the need for adjuvant treatment, specifically the mFOLFOX6 regimen. Patients will be randomized within seven weeks after their surgery, ensuring timely intervention based on their tumor characteristics. The goal is to improve outcomes by tailoring treatment based on individual tumor DNA profiles.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized treatment plans and potentially better outcomes for patients with stage II colon cancer.
How similar studies have gone: Other studies utilizing circulating tumor DNA as a decision-making tool in cancer treatment have shown promising results, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Fédération Francophone de Cancérologie Digestive
Dijon, France Recruiting
Study contacts
- Study coordinator: Julien TAIEB
- Email: julien.taieb@egp.aphp.fr
- Phone: +33 1 56 09 50 42
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.