Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorNorwegian Department of Health and Social Affairs
About this trial
Randomized head-to-head comparison trial among patients who have undergone incomplete endoscopic resection of early colon cancer to evaluate the benefits, harms and burdens, as well as the ecological footprint and cost-effectiveness of endoscopic full thickness resection (eFTR), a minimally invasive endoscopic treatment with a colonoscope, as compared to standard-of-care surgery.
Co-primary endpoints are
* Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment * CRC recurrence or sign of lymph nodes or distant metastases at 3 years after randomization comparing the two treatment groups (eFTR versus surgery).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women, age 40 years or older with endoscopic removal (snare or forceps polypectomy; endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) with R1 (resection margin <0.1mm23,40) or Rx resection margins of colon cancer (location proximal to the rectum (12 cm or more from the anal verge))
No contraindication for colon surgery as deemed by the multidisciplinary tumor board (MTB) at the participating centre
Absence of the following histopathological tumor features: poor differentiation, lymphovascular invasion, tumor budding grade B2-B3.
No sign of disease beyond stage T1N0M0 on standard-of-care computed tomography imaging of the thorax, abdomen and pelvis41 and clinical evaluation
Disqualifiers
all who do not fulfill inclusion criteria
Trial design
Design model
Parallel
Treatments tested in this trial
Tumor removal
Procedure/SurgeryRemoval of incompletely removed early-stage colon cancer
Treatment groups
304 Participants
are divided into 2 treatment groupsGroup A: SurgeryActive comparator 1 intervention
Group B: EFTR (Endoscopic Full-Thickness Resection)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Severe adverse events
Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment
Time frame
30 days2
CRC recurrence or sign of lymph nodes or distant metastases
Rate of CRC recurrence or sign of lymph nodes or distant metastases
Time frame
3 yearsSecondary outcomes
1
CRC recurrence or sign of lymph nodes or distant metastases at 1 year after study treatment
CRC recurrence or metastases
Time frame
1 year2
CRC recurrence or sign of lymph nodes or distant metastases at 5 years after study treatment
CRC recurrence or metastases
Time frame
5 years3
CRC survival and overall survival at 1,3 and 5 years after study treatment
CRC survival and overall survival
Time frame
1, 3, 5 years4
Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 1 year after study treatment
Severe adverse events
Time frame
1 yearOther outcomes
1
Cost-effectiveness
Costs in dollars as compared to effectiveness
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Norwegian Department of Health and Social Affairs
Lead sponsor
Hôpital Edouard Herriot
Collaborator
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborator
Nuovo Regina Margherita Hospital
Collaborator
Karolinska Institutet
Collaborator
Humanitas Clinical and Research Center
Collaborator
Medical University of Gdansk
Collaborator
Universitätsklinikum Hamburg-Eppendorf
Collaborator
University Hospital, Akershus
Collaborator
Vestre Viken Hospital Trust
Collaborator
University Hospital of North Norway
Collaborator
Helse Stavanger HF
Collaborator
Oslo University Hospital
Collaborator
Source ClinicalTrials.gov