Patients With Resected Stage II Colon CancerPhase 3CIRCULATENCT04120701
CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II
A Phase 3 study testing mFOLFOX6 in people with Patients With Resected Stage II Colon Cancer, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The objective of CIRCULATE trial is to improve care of patients after colon tumor surgery, based on an innovative marker: circulating tumor DNA. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients With Resected Stage II Colon Cancer
- What is being tested?
- mFOLFOX6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,980 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2020to Mar 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Fédération Francophone de Cancérologie Digestive
Dijon, 21000
Flore GEILLON, +33 3 80 39 34 04, flore.geillon@u-bourgogne.fr
About this study
The objective of CIRCULATE trial is to improve care of patients after colon tumor surgery, based on an innovative marker: circulating tumor DNA.
- Being tested
- mFOLFOX6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFOX6Drug
Patients receive adjuvant chemotherapy every 2 weeks during 6 months: FOLFOX6m (5-FU, leucovorin and oxaliplatin).
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Experimental | Not described Receives: Drug: mFOLFOX6 |
| Follow-up within the study | No intervention | Not described |
| Follow-up outside the study | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year Disease-Free Survival in ctDNA positive patients
Measured: 3-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start17 Jan 2020
- Primary completionMar 2032 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Resected Stage II Colon CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,980 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120701
- Sponsor's protocol ID
- PRODIGE 70 - CIRCULATE
- Acronym
- CIRCULATE
- Status last verified
- Jul 2026
- First submitted
- 8 Oct 2019
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II
- ClinicalTrials.gov ID
- NCT04120701
- Acronym / sponsor ID
- CIRCULATE / PRODIGE 70 - CIRCULATE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,980 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- Mar 2032 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of CIRCULATE trial is to improve care of patients after colon tumor surgery, based on an innovative marker: circulating tumor DNA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Experimental | Drug: mFOLFOX6 |
| Follow-up within the study | No intervention | – |
| Follow-up outside the study | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mFOLFOX6Patients receive adjuvant chemotherapy every 2 weeks during 6 months: FOLFOX6m (5-FU, leucovorin and oxaliplatin). | Drug | Chemotherapy |
Primary outcome
3-year Disease-Free Survival in ctDNA positive patients
Time frame: 3-years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mFOLFOX6 in people with Patients With Resected Stage II Colon Cancer, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien TAIEB (+33 1 56 09 50 42, julien.taieb@egp.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year Disease-Free Survival in ctDNA positive patients (time frame: 3-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.