RecruitingNot ApplicableNCT06057350

Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR

Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)- a Randomized Controlled Trial

Sponsor

Norwegian Department of Health and Social Affairs

Enrollment

304 participants

Start Date

Oct 27, 2023

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Treatment Side Effects

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).

Eligibility

Min Age: 40 Years

Inclusion Criteria13

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