Clinical trial NCT06057350: Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR
Official title: Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)- a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Treatment Side Effects
Colorectal Cancer
Lead sponsor: Norwegian Department of Health and Social Affairs
Sponsor class: OTHER_GOV
Collaborators: name: Hôpital Edouard Herriot
name: Maria Sklodowska-Curie National Research Institute of Oncology
name: Nuovo Regina Margherita Hospital
name: Karolinska Institutet
name: Humanitas Clinical and Research Center
name: Medical University of Gdansk
name: Universitätsklinikum Hamburg-Eppendorf
name: University Hospital, Akershus
name: Vestre Viken Hospital Trust
name: University Hospital of North Norway
name: Helse Stavanger HF
name: Oslo University Hospital
First posted: 2023-09-28
Enrollment: 304
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Severe adverse events
timeFrame: 30 days
measure: CRC recurrence or sign of lymph nodes or distant metastases
timeFrame: 3 years
Secondary outcomes:
measure: CRC recurrence or sign of lymph nodes or distant metastases at 1 year after study treatment
timeFrame: 1 year
measure: CRC recurrence or sign of lymph nodes or distant metastases at 5 years after study treatment
timeFrame: 5 years
measure: CRC survival and overall survival at 1,3 and 5 years after study treatment
timeFrame: 1, 3, 5 years
measure: Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 1 year after study treatment
timeFrame: 1 year
measure: 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
timeFrame: 30 days
measure: Length of hospital stay after study treatment
timeFrame: 30 days
measure: Hospital readmission rate after discharge within 30 days after study treatment
timeFrame: 30 days
measure: 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
timeFrame: 1 day
measure: Duration of the study procedure
timeFrame: 1 day
measure: Environmental footprint of study procedures at 30 days after study treatment
timeFrame: 30 days
measure: Health related quality of life and functional outcomes after 30 days and one year
timeFrame: 30 days, 1 year
Other outcomes:
measure: Cost-effectiveness
timeFrame: 5 years
Locations:
city: Oslo
country: Norway
facility: Vestre Viken Hospital
state: Viken
city: Oslo
country: Norway
facility: Akershus University Hospital
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie National Research Institute of Oncology
Study officials:
References: