Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR

Recruiting now · Not applicable

Conditions studied: Treatment Side Effects, Colorectal Cancer

In brief

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).

Key facts

Study ID

NCT06057350

Run by

Norwegian Department of Health and Social Affairs

People needed

304

Starts

2023-10-27

Expected to finish

2033-09-01

Last updated by the study team

2024-02-16

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• all who do not fulfill inclusion criteria

Where it is running

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

Full record on ClinicalTrials.gov

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