SCAR: Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR

Sponsor

Norwegian Department of Health and Social Affairs (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06057350

Collaborator

Hôpital Edouard Herriot (Other), Maria Sklodowska-Curie National Research Institute of Oncology (Other), Nuovo Regina Margherita Hospital (Other), Karolinska Institutet (Other), Humanitas Clinical and Research Center (Other), Medical University of Gdansk (Other), Universitätsklinikum Hamburg-Eppendorf (Other), University Hospital, Akershus (Other), Vestre Viken Hospital Trust (Other), University Hospital of North Norway (Other), Helse Stavanger HF (Other), Oslo University Hospital (Other)

304

Enrollment

Arms

120

Anticipated Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Treatment Side Effects Colorectal Cancer	Procedure: Tumor removal	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

304 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2031

Anticipated Study Completion Date :

Sep 1, 2033

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Severe adverse events [30 days]
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 [3 years]
Rate of CRC recurrence or sign of lymph nodes or distant metastases

Secondary Outcome Measures

CRC recurrence or sign of lymph nodes or distant metastases at 1 year after study treatment [1 year]
CRC recurrence or metastases
CRC recurrence or sign of lymph nodes or distant metastases at 5 years after study treatment [5 years]
CRC recurrence or metastases
CRC survival and overall survival at 1,3 and 5 years after study treatment [1, 3, 5 years]
CRC survival and overall survival
Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 1 year after study treatment [1 year]
Severe adverse events
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 [30 days]
mild and moderate adverse events
Length of hospital stay after study treatment [30 days]
Hospital stay
Hospital readmission rate after discharge within 30 days after study treatment [30 days]
Hospital readmission
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 [1 day]
Technical success
Duration of the study procedure [1 day]
Duration of procedure
Environmental footprint of study procedures at 30 days after study treatment [30 days]
Carbon dioxide emission in kgCo2 per procedure
Health related quality of life and functional outcomes after 30 days and one year [30 days, 1 year]
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (0-100 points; higher point scores mean higher QoL)

Other Outcome Measures

Cost-effectiveness [5 years]
Costs in dollars as compared to effectiveness

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 prior surgical colorectal resection
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Bretthauer, Co-Principal Investigator, Norwegian Department of Health and Social Affairs

ClinicalTrials.gov Identifier:

NCT06057350

Other Study ID Numbers:

REK KULMU-B 613856

First Posted:

Sep 28, 2023

Last Update Posted:

Sep 28, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Colonic Neoplasms

Study Results

No Results Posted as of Sep 28, 2023