Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR

Launched by NORWEGIAN DEPARTMENT OF HEALTH AND SOCIAL AFFAIRS · Sep 21, 2023

Keywords

ClinConnect Summary

This clinical trial is comparing two treatment options for patients who have had early colon cancer that was not completely removed during their initial endoscopic procedure. The trial is specifically looking at a new, less invasive technique called endoscopic full thickness resection (eFTR) and comparing it to standard surgical removal of the cancer. Researchers want to see which method has fewer serious side effects, a lower chance of cancer returning in three years, and how these options affect costs and the environment.

To participate in this trial, you must be at least 40 years old and have had a specific type of incomplete endoscopic removal of colon cancer, with no signs of more advanced disease. You also need to be healthy enough for surgery, with no other serious health issues or cancers. Participants will receive either the new eFTR treatment or the standard surgery, and the study will monitor their progress over time. If you or a family member are considering joining, it's essential to understand these details and discuss any questions with your healthcare provider.

Gender

ALL

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