Comparing surgery and endoscopic resection for early colon cancer

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

This study is testing whether a new way to remove early colon cancer using endoscopic techniques is safer and more effective than traditional surgery for patients whose cancer wasn't completely removed.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 304 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Norwegian Department of Health and Social Affairs (other gov)
• Locations: 3 sites (Oslo, Akershus and 2 other locations)
• Trial ID: NCT06057350 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness and safety of endoscopic full thickness resection (eFTR) compared to standard surgical methods for patients with incompletely removed early colon cancer. It involves a randomized head-to-head comparison to assess severe adverse events and cancer recurrence rates over a three-year period. The study also considers the ecological footprint and cost-effectiveness of both treatment approaches. Participants will be monitored for complications and cancer outcomes following their respective treatments.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 40 and older who have undergone incomplete endoscopic removal of early colon cancer without contraindications for surgery.

Not a fit: Patients with advanced tumor features or those with other significant colorectal tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for early colon cancer, potentially reducing recovery time and complications.

How similar studies have performed: Other studies have shown promise in using minimally invasive techniques for cancer treatment, suggesting potential success for this approach.

Eligibility criteria

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

Where this trial is running

Oslo, Akershus and 2 other locations

• Vestre Viken Hospital — Oslo, Akershus, Norway (RECRUITING)
• Akershus University Hospital — Oslo, Norway (RECRUITING)
• Maria Sklodowska-Curie National Research Institute of Oncology — Warsaw, Poland (RECRUITING)

Study contacts

• Study coordinator: Nastazja Pilonis, MD PhD

Conditions: Treatment Side Effects, Colorectal Cancer