Comparing surgery and endoscopic resection for early colon cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness and safety of endoscopic full thickness resection (eFTR) compared to standard surgical methods for patients with incompletely removed early colon cancer. It involves a randomized head-to-head comparison to assess severe adverse events and cancer recurrence rates over a three-year period. The study also considers the ecological footprint and cost-effectiveness of both treatment approaches. Participants will be monitored for complications and cancer outcomes following their respective treatments.

Why it matters

Who can join: the full rules

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

Where it's running

• Vestre Viken Hospital
  Oslo, Akershus, Norway Recruiting
• Akershus University Hospital
  Oslo, Norway Recruiting
• Maria Sklodowska-Curie National Research Institute of Oncology
  Warsaw, Poland Recruiting

Study contacts

• Study coordinator: Nastazja Pilonis, MD PhD
• Email: nastazja@gmail.com
• Phone: +48787863649

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Knife-assisted full-thickness resection for rectal lesions in a multicenter setting

  A multicenter study tests knife-assisted full-thickness resection (kFTR) to remove rectal lesions in adults and see how well it works and how safe it is.

  Recruiting University Hospital, Ghent · Ghent · NCT07923682

• Personalized 3D Bioprinted Colorectal Cancer Microenvironment Model

  This study tests patient-derived, 3D-bioprinted cancer models that include tumor, fibroblast, and immune cells to see if they can better predict how colorectal cancer will respond to treatment.

  Recruiting Peking Union Medical College Hospital · Ningbo, Zhejiang · NCT07919418

• Integrated genomic and clinical database for cancer biomarker discovery

  Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.

  Recruiting Samsung Medical Center · Seoul, Gang-Nam · NCT07911267

• Prehabilitation with Resistance, Aerobic, or Both Before Colorectal Surgery

  Four pre-surgery exercise options (resistance, aerobic, both, or none) will be tested to see which best reduces complications after colorectal cancer surgery.

  Recruiting Semmelweis University · Budapest · NCT07896174

• Liver transplantation for colorectal cancer with liver metastases

  This study follows adults with stage IV colorectal cancer whose disease is limited to the liver and who are getting a liver transplant as part of their cancer care to see how they fare over time.

  Recruiting Pontificia Universidad Catolica de Chile · Santiago, Santiago Metropolitan · NCT07884110

• LTZ-232: a first-in-human test in advanced colorectal and other solid tumors

  A first-in-human study tests LTZ-232, a new therapy for adults with unresectable or metastatic colorectal cancer and other solid tumors that have not responded to standard treatments.

  Recruiting Phase 1 LTZ Therapeutics, Inc. · Scottsdale, Arizona · NCT07878988

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.