CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCentre Hospitalier Universitaire Dijon
About this trial
The objective of CIRCULATE trial is to improve care of patients after colon tumor surgery, based on an innovative marker: circulating tumor DNA.
Eligibility criteria
Qualifiers
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
Disqualifiers
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,
Trial design
Treatments tested in this trial
- mFOLFOX6
Treatment groups
1,980 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov