CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II
NCT ID: NCT04120701
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1980 participants
INTERVENTIONAL
2020-01-17
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemotherapy
mFOLFOX6
Patients receive adjuvant chemotherapy every 2 weeks during 6 months: FOLFOX6m (5-FU, leucovorin and oxaliplatin).
Follow-up within the study
No interventions assigned to this group
Follow-up outside the study
No interventions assigned to this group
Interventions
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mFOLFOX6
Patients receive adjuvant chemotherapy every 2 weeks during 6 months: FOLFOX6m (5-FU, leucovorin and oxaliplatin).
Eligibility Criteria
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Inclusion Criteria
* 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 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)
* Patient affiliated to a social security system
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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Fédération Francophone de Cancérologie Digestive
Dijon, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PRODIGE 70 - CIRCULATE
Identifier Type: -
Identifier Source: org_study_id