Organ-sparing surgery for elderly patients with early colon cancer
Organ SPARring Surgery vs. Standard Resection for Early Stage COLon Cancer in Elderly Frail Patients
This study is testing a new, less invasive surgery for older patients with early colon cancer to see if it can be safer and easier than traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Zealand University Hospital Academic / other |
| Locations | 3 sites (Copenhagen, Herlev and 2 other locations) |
| Trial ID | NCT05734300 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 75 years and older with early-stage colon adenocarcinoma who are suitable for the CELS procedure.
Not a fit: Patients with high-risk histological features or other malignancies, as well as those unable to provide informed consent, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce surgical risks and improve recovery outcomes for elderly patients with early colon cancer.
How similar studies have performed: While this specific approach is novel, similar minimally invasive techniques have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Copenhagen, Herlev and 2 other locations
- Copenhagen University Hospital - Herlev — Copenhagen, Herlev, Denmark (Recruiting)
- Hospital Soenderjylland — Aabenraa, Denmark (Active_not_recruiting)
- Zealand University Hospital — Køge, Denmark (Recruiting)
Study contacts
- Study coordinator: Ilze Ose, MD
- Email: ilos@regionsjaelland.dk
- Phone: 27293399
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.