Colon or Upper Rectum AdenocarcinomaPhase 3CIRCULATE PACNCT06197425
Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer
A Phase 3 study testing "FOLFIRI" cures, Trifluridine cures and BIOLOGICAL ASSESSMENT in people with Colon or Upper Rectum Adenocarcinoma, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon or Upper Rectum Adenocarcinoma
- What is being tested?
- "FOLFIRI" cures, Trifluridine cures and BIOLOGICAL ASSESSMENT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,660 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2026to May 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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.
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
Chu Dijon Bourgogne
Dijon, 21000
Côme LEPAGE, 03 80 29 37 50, come.lepage@u-bourgogne.fr
About this study
Official title: Phase III Multicentric, Open-label, Randomized Study to Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer (PRODIGE 88)
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
- Conditions
- Colon or Upper Rectum Adenocarcinoma
- Being tested
- "FOLFIRI" cures, Trifluridine cures, BIOLOGICAL ASSESSMENT, Questionnaires, Thoracic-abdomino-pelvic scan or MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"FOLFIRI" curesDrug
(Irinotecan 180 mg/m2, leucovorine 400mg/m2, 5FU bolus 400 mg/m2, 5FU continuous infusion 2400 mg/m2) every 14 days for 6 months or until disease progression on imaging
Trifluridine curesDrug
Trifluridine tipiracil 35 mg/m2 bid during 5 days/w on week 1 and 2 every 4 weeks, for 6 months or until disease progression on imaging
BIOLOGICAL ASSESSMENTBiological
blood sample ACE markers
QuestionnairesOther
Quality of life questionnaires (QLQ-C30 ; EQ-5D-5L ; GPAQ)
Thoracic-abdomino-pelvic scan or MRIOther
Thoracic-abdomino-pelvic scan or MRI
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy by FOLFIRI | Experimental | Not described Receives: Drug: "FOLFIRI" cures; Biological: BIOLOGICAL ASSESSMENT; Other: Questionnaires; Other: Thoracic-abdomino-pelvic scan or MRI |
| Chemotherapy by Trifluridine tipiracil | Experimental | Not described Receives: Drug: Trifluridine cures; Biological: BIOLOGICAL ASSESSMENT; Other: Questionnaires; Other: Thoracic-abdomino-pelvic scan or MRI |
| Surveillance inside the trial/control arm | Active comparator | Not described Receives: Biological: BIOLOGICAL ASSESSMENT; Other: Questionnaires; Other: Thoracic-abdomino-pelvic scan or MRI |
| Surveillance outside the trial | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to recurrence (TTR)
The time to recurrence (TTR), in patients treated by FOLFIRI vs surveillance inside the study and in patients treated by Trifluridine Tipiracil vs surveillance inside the study. This TTR is defined as time from randomization to disease recurrence including locoregional or metastatic relapse, death with evidence of recurrence and death from CRC cause.
Measured: From date of randomization until the date of first documented progression or date of death from colorectal cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start7 May 2026
- Primary completionMay 2032 (estimated)
- Study completionMay 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon or Upper Rectum AdenocarcinomaStudies 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
- 1,660 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
- NCT06197425
- Sponsor's protocol ID
- LEPAGE PHRCK 2022
- Acronym
- CIRCULATE PAC
- Status last verified
- May 2026
- First submitted
- 22 Dec 2023
- Last updated
- 22 May 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Multicentric, Open-label, Randomized Study to Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer (PRODIGE 88)
- ClinicalTrials.gov ID
- NCT06197425
- Acronym / sponsor ID
- CIRCULATE PAC / LEPAGE PHRCK 2022
- Conditions
- Colon or Upper Rectum Adenocarcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,660 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 7 May 2026 (actual)
- Primary completion
- May 2032 (estimated)
- Study completion
- May 2032 (estimated)
- First posted
- 9 Jan 2024 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy by FOLFIRI | Experimental | Drug: "FOLFIRI" cures, Biological: BIOLOGICAL ASSESSMENT, Other: Questionnaires, Other: Thoracic-abdomino-pelvic scan or MRI |
| Chemotherapy by Trifluridine tipiracil | Experimental | Drug: Trifluridine cures, Biological: BIOLOGICAL ASSESSMENT, Other: Questionnaires, Other: Thoracic-abdomino-pelvic scan or MRI |
| Surveillance inside the trial/control arm | Active comparator | Biological: BIOLOGICAL ASSESSMENT, Other: Questionnaires, Other: Thoracic-abdomino-pelvic scan or MRI |
| Surveillance outside the trial | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (13 listed)
- 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†
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 |
|---|---|---|
| "FOLFIRI" cures(Irinotecan 180 mg/m2, leucovorine 400mg/m2, 5FU bolus 400 mg/m2, 5FU continuous infusion 2400 mg/m2) every 14 days for 6 months or until disease progression on imaging | Drug | Chemotherapy by FOLFIRI |
| Trifluridine curesTrifluridine tipiracil 35 mg/m2 bid during 5 days/w on week 1 and 2 every 4 weeks, for 6 months or until disease progression on imaging | Drug | Chemotherapy by Trifluridine tipiracil |
| BIOLOGICAL ASSESSMENTblood sample ACE markers | Biological | Chemotherapy by FOLFIRI, Chemotherapy by Trifluridine tipiracil, Surveillance inside the trial/control arm |
| QuestionnairesQuality of life questionnaires (QLQ-C30 ; EQ-5D-5L ; GPAQ) | Other | Chemotherapy by FOLFIRI, Chemotherapy by Trifluridine tipiracil, Surveillance inside the trial/control arm |
| Thoracic-abdomino-pelvic scan or MRIThoracic-abdomino-pelvic scan or MRI | Other | Chemotherapy by FOLFIRI, Chemotherapy by Trifluridine tipiracil, Surveillance inside the trial/control arm |
Primary outcome
The time to recurrence (TTR)
Time frame: From date of randomization until the date of first documented progression or date of death from colorectal cancer
The time to recurrence (TTR), in patients treated by FOLFIRI vs surveillance inside the study and in patients treated by Trifluridine Tipiracil vs surveillance inside the study. This TTR is defined as time from randomization to disease recurrence including locoregional or metastatic relapse, death with evidence of recurrence and death from CRC cause.
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 22 May 2026.
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 "FOLFIRI" cures, Trifluridine cures and BIOLOGICAL ASSESSMENT in people with Colon or Upper Rectum Adenocarcinoma, 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 10 inclusion and 13 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 22 May 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 (01 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?
The time to recurrence (TTR) (time frame: From date of randomization until the date of first documented progression or date of death from colorectal cancer). 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 22 May 2026.