Endoscopic Therapy Or Surgery for Early Colon Cancer
ConditionColon Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNorwegian Department of Health and Social Affairs
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
eFTR
Procedure/Surgeryendoscopic full thickness resection
Surgery
Procedure/Surgerystandard-of-care surgery
Treatment groups
434 Participants
are divided into 2 treatment groupsGroup A: eFTRExperimental treatment 1 intervention
Group B: SurgeryActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of severe adverse events, re-admissions and deaths within 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
Time frame
30 days2
Rate of cancer recurrence or CRC death after three years
primary long-term endpoint of CRC death or cancer recurrence or sign of lymph nodes or distant metastases after three years
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Norwegian Department of Health and Social Affairs
Lead sponsor
Oslo University Hospital
Sponsor institution
Medical University of Gdansk
Collaborator
Vestre Viken Hospital Trust
Collaborator
Universitätsklinikum Hamburg-Eppendorf
Collaborator
Institute of Oncology in Warsaw
Collaborator
Karolinska Institutet
Collaborator
University Hospital, Limoges
Collaborator
University Hospital, Akershus
Collaborator
University of Roma La Sapienza
Collaborator
Hospital Clinic of Barcelona
Collaborator
Leuven University Medical Center
Collaborator
University Hospital, Ghent
Collaborator
Sorlandet Hospital HF
Collaborator
Northern Norway Regional Health Trust
Collaborator
Helse Stavanger HF
Collaborator
Haukeland University Hospital
Collaborator
St. Olavs Hospital
Collaborator
University of Oslo
Collaborator
Frontier Science Foundation
Collaborator
Source ClinicalTrials.gov