Colon Cancer
Conditions
Brief 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.
Interventions
PROCEDUREeFTR
endoscopic full thickness resection
PROCEDURESurgery
standard-of-care surgery
Sponsors
Medical University of Gdansk
Vestre Viken Hospital Trust
Medical Biometry and Epidemiology_- Universitätsklinikum Hamburg Eppendorf
Institute of Oncology in Warsaw
Karolinska Institutet
University Hospital, Limoges
University Hospital, Akershus
University of Roma La Sapienza
Hospital Clinic of Barcelona
Leuven University Medical Center
University Hospital, Ghent
Sørlandet Hospital
Northern Norway Regional Health Trust
Helse Stavanger HF
Haukeland University Hospital
St. Olavs Hospital
University of Oslo
Frontier Science Foundation
Norwegian Department of Health and Social Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of severe adverse events, re-admissions and deaths within 30 days | 30 days | co-primary short-term endpoint is the composite rate of rate of severe adverse events, re-admissions and deaths within 30 days following assigned treatment |
| Rate of cancer recurrence or CRC death after three years | 3 years | primary long-term endpoint of CRC death or cancer recurrence or sign of lymph nodes or distant metastases after three years |
Countries
Poland
Contacts
Primary ContactMICHAEL BRETTHAUER, MD PhD
Outcome results
None listed