CIRCULATE - A TRIAL TO IMPROVE CARE OF PATIENTS AFTER COLON TUMOR SURGERY, BASED ON AN INNOVATIVE MARKER: CIRCULATING TUMOR DNA
- Conditions
- Therapeutic area: Diseases [C] - Cancer [C04]stage II colon cancer, after tumour resection
- Registration Number
- EUCTR2019-000935-15-FR
- Lead Sponsor
- Centre Hospitalier Universitaire (CHU) de Dijon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1980
- 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 registration.
- 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
- Negative pregnancy test performed = 7 before registration (for women of childbearing age)
- 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)
- Patient affiliated to a social security system
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180
- 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
- Known DPD deficiency (for patients afterward randomized in chemotherapy arm, DPD deficiency will be mandatory tested prior to 5FU administration)
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method