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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06057350
Recruitment Status : Recruiting
First Posted : September 28, 2023
Last Update Posted : February 16, 2024
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Michael Bretthauer, Norwegian Department of Health and Social Affairs

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : October 27, 2023
Estimated Primary Completion Date : September 2031
Estimated Study Completion Date : September 2033

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Scars

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Severe adverse events [ Time Frame: 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

  2. CRC recurrence or sign of lymph nodes or distant metastases [ Time Frame: 3 years ]
    Rate of CRC recurrence or sign of lymph nodes or distant metastases


Secondary Outcome Measures :
  1. CRC recurrence or sign of lymph nodes or distant metastases at 1 year after study treatment [ Time Frame: 1 year ]
    CRC recurrence or metastases

  2. CRC recurrence or sign of lymph nodes or distant metastases at 5 years after study treatment [ Time Frame: 5 years ]
    CRC recurrence or metastases

  3. CRC survival and overall survival at 1,3 and 5 years after study treatment [ Time Frame: 1, 3, 5 years ]
    CRC survival and overall survival

  4. Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 1 year after study treatment [ Time Frame: 1 year ]
    Severe adverse events

  5. 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 [ Time Frame: 30 days ]
    mild and moderate adverse events

  6. Length of hospital stay after study treatment [ Time Frame: 30 days ]
    Hospital stay

  7. Hospital readmission rate after discharge within 30 days after study treatment [ Time Frame: 30 days ]
    Hospital readmission

  8. 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 [ Time Frame: 1 day ]
    Technical success

  9. Duration of the study procedure [ Time Frame: 1 day ]
    Duration of procedure

  10. Environmental footprint of study procedures at 30 days after study treatment [ Time Frame: 30 days ]
    Carbon dioxide emission in kgCo2 per procedure

  11. Health related quality of life and functional outcomes after 30 days and one year [ Time Frame: 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:
  1. Cost-effectiveness [ Time Frame: 5 years ]
    Costs in dollars as compared to effectiveness


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06057350


Contacts
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Contact: Nastazja Pilonis, MD PhD +48787863649 nastazja@gmail.com
Contact: Michael Bretthauer, MD PhD +4790132480 michael.bretthauer@medisin.uio.no

Locations
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Norway
Vestre Viken Hospital Recruiting
Oslo, Viken, Norway, 1346
Contact: Jens Aksel Nielsen, MD         
Akershus University Hospital Recruiting
Oslo, Norway
Contact: Linn Bernklev, MD         
Poland
Maria Sklodowska-Curie National Research Institute of Oncology Recruiting
Warsaw, Poland, 02-781
Contact: Michal Kaminski, MD PhD         
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
More Information
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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: September 28, 2023    Key Record Dates
Last Update Posted: February 16, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases