Actively Recruiting
Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon Cancer (SCAR) - a Randomized Controlled Trial
Led by Norwegian Department of Health and Social Affairs · Updated on 2024-02-16
304
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
Sponsors
N
Norwegian Department of Health and Social Affairs
Lead Sponsor
H
Hôpital Edouard Herriot
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a randomized trial comparing two treatments for patients who have undergone incomplete endoscopic removal of early colon cancer. The study aims to evaluate the benefits, potential harms, burdens, environmental impact, and cost-effectiveness of endoscopic full thickness resection (eFTR), a minimally invasive procedure using a colonoscope, compared to standard surgery. The main goals are to assess serious adverse events within 30 days and colon cancer recurrence or spread to lymph nodes or distant sites at 3 years after treatment. Participants are randomly assigned to one of two groups. One group receives surgery following current guidelines, which may include open, laparoscopic, or robotic segmental bowel resection targeting the lymphatic drainage area of the cancer. The other group undergoes eFTR using approved devices, where the scar from the previous removal is identified, documented, and then removed en bloc with the eFTR device mounted on the colonoscope. This design allows a direct comparison of these two approaches. During the study, participants will be closely monitored for safety, cancer recurrence, and other outcomes. Assessments include tracking severe adverse events within 30 days, cancer status at 1, 3, and 5 years, quality of life and functional outcomes, length of hospital stay, readmission rates, and environmental footprint of the procedures. The study also measures technical success and procedure duration. Overall, the trial lasts several years to fully evaluate long-term cancer control and safety.
CONDITIONS
Brief Title
Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 40 years or older with incomplete endoscopic removal of early colon cancer in the colon (not rectum)
- No contraindications for colon surgery as evaluated by a multidisciplinary tumor board
- No poor tumor features such as poor differentiation, lymphovascular invasion, or high-grade tumor budding
- No signs of disease beyond stage T1N0M0 based on imaging and clinical evaluation
- Able to identify the resection site by colonoscopy with tattoo or scar
- No other tumors or polyps larger than 10 mm in the colorectum at randomization
- Complete colonoscopy with good bowel preparation and documented landmarks
- No colonic strictures or severe diverticulosis
- No prior colorectal cancer
- No other active malignant disease
- No confirmed or suspected genetic cancer syndromes such as Lynch or polyposis syndromes
- No inflammatory bowel disease
- Provided written informed consent before enrollment
You will not qualify if you...
- Any individual who does not meet all of the inclusion criteria
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants randomized to surgery undergo segmental bowel resection according to guidelines to remove early colon cancer.
1 surgical procedure visit
Duration - 1 day
Participants randomized to EFTR undergo endoscopic full-thickness resection of the colon cancer scar using approved devices.
1 procedure visit
Duration - 30 days
Participants are monitored for adverse events, hospital stay, readmission, and recovery after their procedure.
Approximately 6 post-operative visits
Duration - 5 years
Participants are followed for up to 5 years to monitor for cancer recurrence, survival, and quality of life.
Annual visits for up to 5 years
Trial Site Locations
Total: 3 locations
1
Vestre Viken Hospital
Oslo, Akershus, Norway, 1346
Actively Recruiting
2
Akershus University Hospital
Oslo, Norway
Actively Recruiting
3
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland, 02-781
Actively Recruiting
Research Team
N
Nastazja Pilonis, MD PhD
M
Michael Bretthauer, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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