Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)

Norwegian Department of Health and Social Affairs

Status: Enrolling

Conditions: Treatment Side Effects; Colorectal Cancer

Treatments: Procedure: Tumor removal

Study type: Interventional

Funder types: Other

Identifiers

NCT06057350

REK KULMU-B 613856

Details and patient eligibility

About

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).

Enrollment: 304 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• all who do not fulfill inclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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304 participants in 2 patient groups

Surgery

Active Comparator group

Description:

Patients randomized to surgery are treated according to current guidelines with either open, laparoscopic or robotic surgical segmental bowel resection corresponding to lymphovascular drainage of the cancer.

Treatment:

Procedure: Tumor removal

EFTR (Endoscopic Full-Thickness Resection)

Experimental group

Description:

Patients randomised to EFTR are treated using devices approved for eFTR in the European Union and affiliated countries for the indication as applied in the trial. Before EFTR, the scar is identified and documented. The colonoscope is then removed, the EFTR device mounted, the colonoscope re-introduced, and eFTR performed.

Treatment:

Procedure: Tumor removal