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Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR
Sponsor: Norwegian Department of Health and Social Affairs
Summary
Randomized head-to-head comparison trial among patients who have undergone incomplete endoscopic resection of early colon cancer to evaluate the benefits, harms and burdens, as well as the ecological footprint and cost-effectiveness of endoscopic full thickness resection (eFTR), a minimally invasive endoscopic treatment with a colonoscope, as compared to standard-of-care surgery. Co-primary endpoints are * Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment * CRC recurrence or sign of lymph nodes or distant metastases at 3 years after randomization comparing the two treatment groups (eFTR versus surgery).
Official title: Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)- a Randomized Controlled Trial
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
304
Start Date
2023-10-27
Completion Date
2033-09
Last Updated
2024-02-16
Healthy Volunteers
No
Conditions
Interventions
Tumor removal
Removal of incompletely removed early-stage colon cancer
Locations (3)
Vestre Viken Hospital
Oslo, Akershus, Norway
Akershus University Hospital
Oslo, Norway
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland