Spots Global Cancer Trial Database for Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR
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Trial Identification
Brief Title: Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR
Official Title: Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)- a Randomized Controlled Trial
Study ID: NCT06057350
Interventions
Study Description
Brief 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).
Detailed Description:
Keywords
Eligibility
Minimum Age: 40 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Vestre Viken Hospital, Oslo, Viken, Norway
Akershus University Hospital, Oslo, , Norway
Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, , Poland
Contact Details
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