Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer

Recruiting now · Phase 3

Conditions studied: Colon or Upper Rectum Adenocarcinoma

In brief

Phase III multicentric, open-label, randomized study The main objective is to assess the efficacy on time to disease recurrence (TTR) of treating minimal residual disease diagnosed by the presence of ctDNA after full treatment (surgery + chemotherapy) in stage III or high-risk stage II colon or upper rectum adenocarcinoma

Key facts

Study ID: NCT06197425
Run by: Centre Hospitalier Universitaire Dijon
People needed: 1660
Starts: 2026-05-07
Expected to finish: 2032-05-01
Last updated by the study team: 2026-05-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Fully resected stage III or high-risk stage II colon or upper rectum adenocarcinoma previously treated by standard adjuvant chemotherapy or peri-operative chemotherapy (FOLFOX or CAPOX) for either 3 or 6 months based on local multidisciplinary meeting, and on TNCD recommendations
Positive ctDNA screening (methylation) and confirmation (NGS) on samples collected at the 3- or 6 months follow-up visit post-adjuvant chemotherapy
Patients ≥ 18 years and ≤ 80 years (provided the score of the G8 geriatric questionnaire is >14 for patients 70 years or older)
Subjects with WHO performance status < 2
No documented disease using TAP CT-scanner and liver MRI in the case of contra-indication to dye contrast (or TEP-scanner may be also used in addition depending on physicians' choice and local availabilities).
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 Creatinine clearance ≥50 ml/min according MDRD (Modification of Diet in Renal Disease)
Available tumor sample for NGS analysis
Signed written informed consent obtained prior to any study specific procedures
Patient affiliated to a social security scheme

You may not qualify if…

Patients already treated with trifluridine tipiracil or irinotecan in the past 5 years
Uncontrolled intercurrent illness
Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 3 years
Pregnant or breastfeeding women, women of childbearing age not having had a negative pregnancy test
Any known specific contraindication or allergy to the treatments used in the study†
Total or partial dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia > 16ng/ml)
Known Gilbert's disease (UGT1A1*28 genotype)
In case of concomitant use with St John's Wort related to irinotecan
In case of bowel obstruction according related to irinotecan
In case of recent concomitant treatment with brivudine, related to fluorouracil.
Participation to another interventional study for postoperative therapy
Persons deprived of liberty or under guardianship or incapable of giving consent
Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.

Where it is running

Chu Dijon Bourgogne — Dijon, France (enrolling)

Full record on ClinicalTrials.gov

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