Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR

Last updated: February 15, 2024
Sponsor: Norwegian Department of Health and Social Affairs
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer; Rectal Cancer

Rectal Cancer

Colon Cancer

Treatment

Tumor removal

Clinical Study ID

NCT06057350
REK KULMU-B 613856
  • Ages > 40
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Men and women, age 40 years or older with endoscopic removal (snare or forcepspolypectomy; 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 imagingof the thorax, abdomen and pelvis41 and clinical evaluation
  • Identifiable resection site with colonoscopy, either by visualizing a previouslyadministered 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 ofrandomization
  • Complete colonoscopy with adequate quality of bowel preparation (Boston BowelPreparation Scale score ≤2 in all colonic segments) and photo or video documentationof 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/serratedlesions, adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
  • No inflammatory bowel disease
  • Written informed consent provided by before enrolment

Exclusion

Exclusion Criteria:

  • all who do not fulfill inclusion criteria

Study Design

Total Participants: 304
Treatment Group(s): 1
Primary Treatment: Tumor removal
Phase:
Study Start date:
October 27, 2023
Estimated Completion Date:
September 30, 2033

Connect with a study center

  • Vestre Viken Hospital

    Oslo, Viken 1346
    Norway

    Active - Recruiting

  • Akershus University Hospital

    Oslo,
    Norway

    Active - Recruiting

  • Maria Sklodowska-Curie National Research Institute of Oncology

    Warsaw, 02-781
    Poland

    Active - Recruiting

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