Comparing a scope-based removal with surgery for early colon cancer
Compares scope-based removal with surgery in adults with early colon cancer.
Plain-language title generated from the registry record
Registry title: Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR
Key facts
- Where
- Warsaw, PolandSee the site
Where in Poland
- Maria Sklodowska-Curie - National Research Institute of OncologyWarsaw, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Norwegian Department of Health and Social Affairs
- Trial code
- NCT06057350
- Record updated
- 16 February 2024
- Original description
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.Read full original descriptionShow less
Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)- a Randomized Controlled Trial
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).
Inclusion: Men and women, age 40 years or older with endoscopic removal (snare or forceps polypectomy; endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) with R1 (resection margin <0.1mm23,40) or Rx resection margins of colon cancer (location proximal to the rectum (12 cm or more from the anal verge)); No contraindication for colon surgery as deemed by the multidisciplinary tumor board (MTB) at the participating centre; Absence of the following histopathological tumor features: poor differentiation, lymphovascular invasion, tumor budding grade B2-B3; No sign of disease beyond stage T1N0M0 on standard-of-care computed tomography imaging of the thorax, abdomen and pelvis41 and clinical evaluation; Identifiable resection site with colonoscopy, either by visualizing a previously administered tattoo or by identification of a scar in the correct colon segment; No other tumors or polyps larger than 10 mm in diameter in the colorectum at time of randomization; Complete colonoscopy with adequate quality of bowel preparation (Boston Bowel Preparation Scale score ≤2 in all colonic segments) and photo or video documentation of the appendiceal orifice or ileocecal valve; No colonic strictures or severe diverticulosis; No prior CRC; No other malignant disease which is not deemed cured; No confirmed or suspected genetic cancer syndrome (10 or more adenomas/serrated lesions, adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome); No inflammatory bowel disease; Written informed consent provided by before enrolment.
Exclusion: all who do not fulfill inclusion criteria.