Randomized controlled trial of surgery and endoscopic resection for incompletely removed early colon cancer (SCAR trial)

Due to implementation of organized colorectal cancer screening in Sweden and many other European countries, the number of patients with early-stage colon cancer are rapidly growing.

This is a positive outcome of screening but demands more sophisticated minimally invasive treatment techniques.The SCAR trial is a randomized head-to-head comparison trial of patients who have undergone incomplete endoscopic removal (polypectomy, EMR) of early colon cancer (P) for complete and definitive treatment of the cancer.

A novel minimally invasive treatment with colonoscope - endoscopic full-thickness resection (I) - will be compared to standard-of-care surgery (C).

The 160 patients needed in each allocation arm, will be asked to be included in the trial at the endoscopy centers after eligibility assessment by the local multidisciplinary tumor board.

The co-primary outcomes are adverse events (O1) and cancer recurrence (O2), estimated after 30 days of treatment and 3-years of follow-up (T), respectively.

The secondary outcomes are quality of life, cost-effectiveness, and ecological footprint.With successful analyses in approximately 5-years after trial start, the results may lead to complete re-thinking of treatment approaches in these patients.

There would be a tremendous potential in decreasing overtreatment with the advanced surgery used today, in favor of an as effective, but safer, endoscopic treatment that improves quality of life and that can be performed in an out-patient setting.