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

Plain Language Summary

Simplified for easier understanding

This study is comparing surgery versus active surveillance (watchful waiting) after a colon cancer polyp was removed with unclear or positive edges, to determine the safest approach when the cancer may not have been fully removed by the initial endoscopy. **You may be eligible if...** - You are a man or woman aged 40 or older - A colon polyp with early cancer (T1N0M0 stage) was removed during colonoscopy but with unclear or positive margins (incomplete removal) - The tumor did not have poor differentiation, lymphovascular invasion, or high-grade tumor budding - Surgery for your colon is not contraindicated based on the multidisciplinary tumor board review **You may NOT be eligible if...** - The polyp removal site cannot be identified on follow-up colonoscopy - Your tumor shows high-risk features such as lymphovascular invasion or poor differentiation - Your cancer is in the rectum (within 12 cm of the anal opening) - Imaging shows cancer spread beyond the colon Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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