CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II

  • STATUS
    Recruiting
  • End date
    Jan 27, 2028
  • participants needed
    1980
  • sponsor
    Centre Hospitalier Universitaire Dijon
Updated on 27 October 2021

Summary

The objective of CIRCULATE trial is to improve care of patients after colon tumor surgery, based on an innovative marker: circulating tumor DNA.

Details
Condition Patients With Resected Stage II Colon Cancer
Treatment mFOLFOX6
Clinical Study IdentifierNCT04120701
SponsorCentre Hospitalier Universitaire Dijon
Last Modified on27 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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 mol/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

Exclusion Criteria

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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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