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PRODIGE 88-CIRCULATE PAC: 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 high-risk stage II and stage III Colorectal Cancer
EU CTIS ID: 2023-505046-26-00
What this study is testing
show a longer TTR in circulating tumor DNA positive (ctDNA+) patients treated in arm A with FOLFIRI + Bevacizumab (Bev) or in arm B with Trifluridine Tipiracil (TT) + Bev vs. those in the clinical and ctDNA surveillance/control arm (arm C).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Fully resected R0 stage III or high-risk stage II† colon or upper rectal adenocarcinoma treated with standard (neo)adjuvant chemotherapy-ACT (FOLFOX/ CAPOX) for 3 to 6 months based on local multidisciplinary meeting
- Patient affiliated to a social security scheme
- Patients ≥ 18 years (provided the score of the G8 geriatric questionnaire is >14 for patients 70 years or older)
- WHO performance status < 2
- No residual disease on TAP CT-scanner and/or liver MRI + thoracic CT-scan in the case of contra-indication to dye contrast and PET-scan (if available), within 3 weeks of the screening visit.
- Adequate hematological, renal and liver functions: neutrophils ≥ 1,5 G/L, platelet count ≥ 100 G/L, hemoglobin ≥ 9 g/dL (5,6 mmol/l); Total bilirubin ≤ 1.5 x ULN (upper limit of normal); AST and ALT ≤ 2.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN; Creatinine clearance ≥50 ml/min according to CKD EPI formula
You likely can't join if
- Patients already treated with trifluridine tipiracil or irinotecan or Bevacizumab in the past 3 years
- Uncontrolled intercurrent illness
- dMMR/MSI-H colon cancer
- 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
- Deep arterial thromboembolic events including cerebrovascular accident or myocardial infarction within the last 6 months prior to randomization. Uncontrolled hypertension or symptomatic arrhythmia
See the full eligibility criteria
Who can join
- Fully resected R0 stage III or high-risk stage II† colon or upper rectal adenocarcinoma treated with standard (neo)adjuvant chemotherapy-ACT (FOLFOX/ CAPOX) for 3 to 6 months based on local multidisciplinary meeting
- Patient affiliated to a social security scheme
- Patients ≥ 18 years (provided the score of the G8 geriatric questionnaire is >14 for patients 70 years or older)
- WHO performance status < 2
- No residual disease on TAP CT-scanner and/or liver MRI + thoracic CT-scan in the case of contra-indication to dye contrast and PET-scan (if available), within 3 weeks of the screening visit.
- Adequate hematological, renal and liver functions: neutrophils ≥ 1,5 G/L, platelet count ≥ 100 G/L, hemoglobin ≥ 9 g/dL (5,6 mmol/l); Total bilirubin ≤ 1.5 x ULN (upper limit of normal); AST and ALT ≤ 2.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN; Creatinine clearance ≥50 ml/min according to CKD EPI formula
- Available tumor sample and pathological report
- Negative pregnancy test in woman with childbearing potential
- Women of childbearing potential must agree to use a highly effective method of contraception during the trial and for at least 6 months after discontinuation of the experimental treatments. Men who have sexual relations with women of childbearing potential must agree to use contraception during treatment and for at least 6 months after discontinuation of the experimental treatments
- Signed written informed consent obtained prior to any study specific procedures
What rules you out
- Patients already treated with trifluridine tipiracil or irinotecan or Bevacizumab in the past 3 years
- Uncontrolled intercurrent illness
- dMMR/MSI-H colon cancer
- 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
- Deep arterial thromboembolic events including cerebrovascular accident or myocardial infarction within the last 6 months prior to randomization. Uncontrolled hypertension or symptomatic arrhythmia
- Therapy should not be initiated for at least 28 days following major surgery (the surgical incision should be fully healed prior to study drug administration)
- Any known specific contraindication or allergy to the treatments used in the study
- Total or partial dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia > 16ng/ml)
- Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanized antibodies (related to Bevacizumab).
- Known Uridine Diphosphate Glucuronyltransferase (UGT1A1) deficiency or Known Gilbert’s disease
- Continuous intake of strong inducers of CYP3A4 (posaconazole, voriconazole, itraconazole, isavuconazole, ritonavir, verapamil, diltiazem, grapefruit juice (equivalent to one half a day)
- Continuous intake of strong inhibitors of CYP3A4 (St John’s Wort, Hypericum perforatum, rifampicin, phenobarbital, primidone, phenytoin and carbamazepin)
- Bowel obstruction
- Recent concomitant treatment with brivudine (related to fluorouracil)
- Participation in 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.