Organ-sparing surgery for elderly patients with 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 study evaluates a new organ-preserving surgical approach called Combined Endoscopic Laparoscopic Surgery (CELS) for elderly patients diagnosed with early-stage colon cancer. The aim is to determine if this less invasive technique can reduce the risks associated with traditional resection methods, particularly for frail patients. Participants aged 75 and older with specific tumor characteristics will be recruited to assess the safety and effectiveness of CELS compared to standard resection. The study focuses on minimizing surgical trauma while ensuring effective cancer treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male and Female participants providing written informed consent aged 75 years and older
* PS score ≥1 and /or ASA score ≥3
* Macroscopically or pathological colonic adenocarcinoma
* Clinical TNM classification T1/T2 N0 M0
* Eligible and suitable for CELS resection according to MDT
* Tumor must be located in colon, and not involving the ileac valve or taking up more than 50% of the lumen in an air-distended bowel wall

Exclusion Criteria:

* Unable to give informed consent
* Histological high-risk features in biopsy material from tumor (mucin, signet cells, de- differentiation)
* Suspected other malignancy than adenocarcinoma (e.g. neuroendocrine tumors)
* Preoperative chemo/radiotherapy
* Creation of stoma perioperative
* Non-Danish speakers

Where it's running

• Copenhagen University Hospital - Herlev
  Copenhagen, Herlev, Denmark Recruiting
• Zealand University Hospital
  Køge, Denmark Recruiting
• Hospital Soenderjylland
  Aabenraa, Denmark Active not recruiting

Study contacts

• Study coordinator: Ilze Ose, MD
• Email: ilos@regionsjaelland.dk
• Phone: 27293399

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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.