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PRODIGE 70 - CIRCULATE - CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II
EU CTIS ID: 2024-515297-27-00
What this study is testing
To improve Disease Free Survival (DFS) of centralized ctDNA positive patients by the administration of FOLFOX6m adjuvant treatment.
- 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
- Signed written informed consent obtained prior to any study specific procedures
- 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)
You likely can't join if
- T4b tumors
- Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women. Men engaging in sexual activity with women of childbearing potential, and women of childbearing potential should agree to use a method of contraception during treatment of the trial and at least 6 months after discontinuation of said treatment.
- Stage I tumors (T1 or T2N0)
- 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
See the full eligibility criteria
- Signed written informed consent obtained prior to any study specific procedures
- 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)
- Age ≥ 18 years and ≤ 80 years (provided the score of the G8 geriatric questionnaire is >14 for patients 70 years or older)
- Patient affiliated to a social security system
- 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 also be included
- All patients must have been discussed in multidisciplinary meetings with a decision of not performing adjuvant chemotherapy
- No metastatic disease on CT-Scan and/or liver MRI done within 3 months before randomization.
- Randomization planned up to 11 weeks maximun after curative R0 resection
- WHO performance Status < 2
- T4b tumors
- Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women. Men engaging in sexual activity with women of childbearing potential, and women of childbearing potential should agree to use a method of contraception during treatment of the trial and at least 6 months after discontinuation of said treatment.
- Stage I tumors (T1 or T2N0)
- 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
- study for postoperative therapy - Partial
- 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,
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, 18-64 years, 65+ 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.