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New treatment option for Patients With Resected Stage II Colon Cancer
Official title CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II
ClinicalTrials.gov ID: NCT04120701
What this study is testing
What is mFOLFOX6?
mFOLFOX6 is an investigational medicine, being studied as a potential treatment for patients with resected stage ii colon cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objective of CIRCULATE trial is to improve care of patients after colon tumor surgery, based on an innovative marker: circulating tumor DNA.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- At least 12 lymph nodes analyzed
- Patient with MSI + tumors can be included
You likely can't join if
- 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 treatment study for postoperative therapy
- Partial or complete DPD deficiency
See the full eligibility 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...
- 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
- 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 treatment 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 ≥...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Dijon, France
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 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dijon, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.