Comparing a scope-based removal with surgery for early colon cancer
Compares scope-based removal with surgery in adults with early colon cancer.
Key facts
- Who runs it
- Norwegian Department of Health and Social Affairs
- Where
- Warsaw, PolandSee the siteAlso in 1 other country, 2 sites
- Trial code
- Registry title
- Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR
- Status
- Recruiting
- People taking part
- 304 people, planned
- Started
- 27 Oct 2023
- Expected to end
- Sept 2033
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Tumor removal
- Record updated
- 16 February 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 or older whose early colon cancer was removed through a colonoscope, but the removal may not have been complete.
- Age
- 40 years or older
- Sex
- Men and women can join
- Disease stage
- Early colon cancer, stage T1N0M0, in the colon at least 12 cm (4.7 in) from the anal verge. The cancer was removed with an endoscope, and the removal edge was incomplete or unclear (R1 or Rx). The scar can be found on colonoscopy. The tumour cells look low-risk under the microscope (not poorly differentiated, no lymphovascular invasion, no tumour budding grade B2-B3).
- Earlier treatment
- Must have had the cancer removed through a colonoscope (snare or forceps polypectomy, EMR or ESD). No prior colorectal cancer.
Main reasons for not taking part
- Any reason that rules out colon surgery, as judged by the tumour board
- Other colon tumours or polyps larger than 10 mm
- Narrowing of the colon or severe diverticulosis
- Known or suspected inherited cancer syndrome (for example Lynch syndrome or polyposis)
- Inflammatory bowel disease
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- all who do not fulfill inclusion criteria
Where in Poland
Also in 1 other country, 2 sites
- Maria Sklodowska-Curie - National Research Institute of OncologyWarsaw, PolandContact: Michal Kaminski, MD PhDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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).
The 2 groups in the trial
- SurgeryExisting treatment, for comparison
Patients randomized to surgery are treated according to current guidelines with either open, laparoscopic or robotic surgical segmental bowel resection corresponding to lymphovascular drainage of the cancer.
Treatment: Tumor removal
- EFTR (Endoscopic Full-Thickness Resection)Treatment being tested
Patients randomised to EFTR are treated using devices approved for eFTR in the European Union and affiliated countries for the indication as applied in the trial. Before EFTR, the scar is identified and documented. The colonoscope is then removed, the EFTR device mounted, the colonoscope re-introduced, and eFTR performed.
Treatment: Tumor removal
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)- a Randomized Controlled Trial
- Plain-language title
- Comparing a scope-based removal with surgery for early colon cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 16 February 2024