Endoscopic Therapy Or Surgery for Early Colon Cancer

Summary

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.

Eligibility

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

Conditions2

Browse More Trials