NCT06057350Recruiting
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
Source: ClinicalTrials.gov · Last updated 16 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 304 (estimated)
- First submitted
- 12 Aug 2023
- Start date
- 27 Oct 2023
- Primary completion date
- Sept 2031
- Lead sponsor
- Norwegian Department of Health and Social Affairs
- Diseases
- Colorectal cancer
- NCT number
- NCT06057350
What you commit to
- Study type: Interventional
- Planned participants: 304
- From 27 Oct 2023 to the primary completion date, Sept 2031
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- all who do not fulfill inclusion criteria
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Akershus University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Vestre Viken Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Maria Sklodowska-Curie - National Research Institute of Oncology Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.