Recruiting
CIRCULATECIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II
What is being tested
mFOLFOX6
Drug
Who is being recruted
From 18 to 75 Years
+29 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: January 2020
Summary
Principal SponsorCentre Hospitalier Universitaire Dijon
Study ContactJulien TAIEB
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: January 17, 2020
Actual date on which the first participant was enrolled.The objective of CIRCULATE trial is to improve care of patients after colon tumor surgery, based on an innovative marker: circulating tumor DNA.
Official TitleCIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II
Principal SponsorCentre Hospitalier Universitaire Dijon
Study ContactJulien TAIEB
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
1980 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
20 inclusion criteria required to participate
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
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9 exclusion criteria prevent from participating
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,
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
Fédération Francophone de Cancérologie Digestive
Dijon, FranceOpen Fédération Francophone de Cancérologie Digestive in Google MapsRecruiting
One Study Center