Actively Recruiting
CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II
Led by Centre Hospitalier Universitaire Dijon · Updated on 2021-10-22
1980
Participants Needed
1
Research Sites
415 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of CIRCULATE trial is to improve care of patients after colon tumor surgery, based on an innovative marker: circulating tumor DNA.
CONDITIONS
Official Title
CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any study procedures
- Age 18 to 75 years
- Histologically confirmed stage II colon or high rectum adenocarcinoma without residual disease after surgery
- At least 12 lymph nodes analyzed
- Microsatellite instability positive tumors allowed
- Multidisciplinary team decided no adjuvant chemotherapy needed
- No metastatic disease on CT scan or liver MRI within 3 months before randomization
- Randomization within 7 weeks after curative R0 surgery
- WHO performance status less than 2
- No prior chemotherapy or abdominal/pelvic radiation for colorectal cancer
- Life expectancy of at least 5 years
- Adequate blood counts and organ function
- Carcinoembryogenic antigen (CEA) level within normal limits after surgery
- Negative pregnancy test for women of childbearing age
- Affiliated with a social security system
You will not qualify if you...
- T4b tumors
- Peripheral neuropathy greater than grade 1
- Comorbidities affecting 5-year survival including significant cardiovascular disease
- Heart attack in the last year or unstable ischemic heart disease
- Participation in another postoperative therapy study
- Partial or complete DPD enzyme deficiency
- Legal incapacity or conditions interfering with consent or study completion
- History of other active cancers except certain treated skin or cervical cancers or remission over 5 years
- Lack of effective contraception in men or women of childbearing potential, pregnant or breastfeeding women
- Women must use contraception during treatment and for months after stopping oxaliplatin and 5-FU
- Men must use contraception during treatment and for months after stopping oxaliplatin and 5-FU
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fédération Francophone de Cancérologie Digestive
Dijon, France, 21000
Actively Recruiting
Research Team
J
Julien TAIEB
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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