Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR

Colorectal Cancer Clinical Trial

— SCAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06057350
• Other study ID #: REK KULMU-B 613856
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2023
• Est. completion date: September 2033

Study information

• Verified date: February 2024
• Source: Norwegian Department of Health and Social Affairs
• Contact: Nastazja Pilonis, MD PhD
• Phone: +48787863649
• Email: nastazja[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: September 2033
• Est. primary completion date: September 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer
• Treatment Side Effects

Intervention

Procedure:
• Tumor removal
Removal of incompletely removed early-stage colon cancer

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Oslo
Norway	Vestre Viken Hospital	Oslo	Viken
Poland	Maria Sklodowska-Curie National Research Institute of Oncology	Warsaw

Sponsors (13)

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

Countries where clinical trial is conducted

Norway,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost-effectiveness	Costs in dollars as compared to effectiveness	5 years
Primary	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
Primary	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	CRC recurrence or sign of lymph nodes or distant metastases at 1 year after study treatment	CRC recurrence or metastases	1 year
Secondary	CRC recurrence or sign of lymph nodes or distant metastases at 5 years after study treatment	CRC recurrence or metastases	5 years
Secondary	CRC survival and overall survival at 1,3 and 5 years after study treatment	CRC survival and overall survival	1, 3, 5 years
Secondary	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
Secondary	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
Secondary	Length of hospital stay after study treatment	Hospital stay	30 days
Secondary	Hospital readmission rate after discharge within 30 days after study treatment	Hospital readmission	30 days
Secondary	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
Secondary	Duration of the study procedure	Duration of procedure	1 day
Secondary	Environmental footprint of study procedures at 30 days after study treatment	Carbon dioxide emission in kgCo2 per procedure	30 days
Secondary	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