Endoscopic Therapy Or Surgery for Early Colon Cancer
Recruiting · NCT06940947 · Interventional (participants receive a specific treatment) · Lead sponsor: Norwegian Department of Health and Social Affairs
View the official record on ClinicalTrials.gov →Interventions studied
SurgeryeFTR
What this trial is about
The trial is a randomized head-to-head comparison of the benefits, harms and burdens of endoscopic full-thickness resection (eFTR), a novel, minimally invasive endoscopic treatment modality, for early colon cancer as compared to standard-of-care surgery.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Newly diagnosed biopsy-confirmed colon cancer (adenocarcinoma) with macroscopic suspicion of submucosal invasion considered removable by EFTR as deemed by the local multidisciplinary team (MDT) at the participating center
- Size ≤20 mm in diameter as deemed by the colonoscopist
- No presence of histopathological high-risk features in biopsy (high grade tumor growth, budding grade 2 or 3, or lymphovascular invasion)
- Patient eligible for surgical removal as deemed by the local MDT at the participating center
- Endoscopic images or video of the tumor
- No sign of disease beyond T2N0M0 on pre-treatment imaging, biopsy sampling, and radiographic and clinical evaluation
- No contraindication for any of the two treatment arms
- Written informed consent
- No prior or synchronous CRC
- No other malignancy which is not cured
- No more than 10 adenomas or serrated polyps
- No genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
- No inflammatory bowel disease
Where it is running
1 location listed.
- Medical University of Gdańsk - Gdansk, Poland