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NCT Number: NCT06057350

Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR

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).

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vestre Viken Hospital, Oslo, Akershus, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tumor removal

Procedure

Removal of incompletely removed early-stage colon cancer

Primary outcomes

  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 outcomes

  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 outcomes

  1. Cost-effectiveness

    Time frame: 5 years

    Costs in dollars as compared to effectiveness

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Bretthauer, MD PhD

CONTACT

[email protected]

+4790132480

Nastazja Pilonis, MD PhD

CONTACT

[email protected]

+48787863649

Sponsors and collaborators

Lead sponsor

Norwegian Department of Health and Social Affairs

Other Gov

Collaborators

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

Registry information

Official study title

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

Acronym: SCAR

Important dates

Study start
2023
Primary completion
2031
Study completion
2033
First posted
Sep 28, 2023
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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