Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)

Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)- a Randomized Controlled Trial

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).

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Treatment Side Effects
• Intervention / Treatment: Procedure: Tumor removal

• Study Type: Interventional
• Enrollment (Estimated): 304
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nastazja Pilonis, MD PhD; Phone Number: +48787863649; Email: nastazja@gmail.com
• Study Contact Backup: Name: MICHAEL BRETTHAUER, MD PhD; Phone Number: +4790132480; Email: michael.bretthauer@medisin.uio.no

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • Akershus University Hospital
    • Contact: Linn Bernklev, MD
  • Viken
    • Oslo, Viken, Norway, 1346
      • Recruiting
      • Vestre Viken Hospital
      • Contact: Jens Aksel Nielsen, MD
• Poland
  • Warsaw, Poland, 02-781
    • Recruiting
    • Maria Sklodowska-Curie National Research Institute of Oncology
    • Contact: Michal Kaminski, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• all who do not fulfill inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgery; 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.	Procedure: Tumor removal; Removal of incompletely removed early-stage colon cancer
Experimental: EFTR (Endoscopic Full-Thickness Resection); 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.	Procedure: Tumor removal; Removal of incompletely removed early-stage colon cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe adverse events	Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment	30 days
CRC recurrence or sign of lymph nodes or distant metastases	Rate of CRC recurrence or sign of lymph nodes or distant metastases	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRC recurrence or sign of lymph nodes or distant metastases at 1 year after study treatment	CRC recurrence or metastases	1 year
CRC recurrence or sign of lymph nodes or distant metastases at 5 years after study treatment	CRC recurrence or metastases	5 years
CRC survival and overall survival at 1,3 and 5 years after study treatment	CRC survival and overall survival	1, 3, 5 years
Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 1 year after study treatment	Severe adverse events	1 year
Rate of mild and moderate adverse events classified as grade I and II according to the Clavien Dindo classification at 30 days after study treatment	mild and moderate adverse events	30 days
Length of hospital stay after study treatment	Hospital stay	30 days
Hospital readmission rate after discharge within 30 days after study treatment	Hospital readmission	30 days
Technical success of the trial procedures, defined as completion of eFTR and surgery as planned with endoscopic complete en-bloc scar excision or complete surgical resection	Technical success	1 day
Duration of the study procedure	Duration of procedure	1 day
Environmental footprint of study procedures at 30 days after study treatment	Carbon dioxide emission in kgCo2 per procedure	30 days
Health related quality of life and functional outcomes after 30 days and one year	European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (0-100 points; higher point scores mean higher QoL)	30 days, 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness	Costs in dollars as compared to effectiveness	5 years

Collaborators and Investigators

• Sponsor: Norwegian Department of Health and Social Affairs
• Collaborators: Vestre Viken Hospital Trust; Karolinska Institutet; Oslo University Hospital; University Hospital of North Norway; Humanitas Clinical and Research Center; Helse Stavanger HF; Hôpital Edouard Herriot; University Hospital, Akershus; Universitätsklinikum Hamburg-Eppendorf; Medical University of Gdansk; Maria Sklodowska-Curie National Research Institute of Oncology; Nuovo Regina Margherita Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2023
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2033

Study Registration Dates

• First Submitted: August 12, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: REK KULMU-B 613856

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No