Treatment Side Effects, Colorectal Cancer
Conditions
Brief summary
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).
Interventions
PROCEDURETumor removal
Removal of incompletely removed early-stage colon cancer
Sponsors
Hôpital Edouard Herriot
Maria Sklodowska-Curie National Research Institute of Oncology
Nuovo Regina Margherita Hospital
Karolinska Institutet
Humanitas Clinical and Research Center
Medical University of Gdansk
Universitätsklinikum Hamburg-Eppendorf
University Hospital, Akershus
Vestre Viken Hospital Trust
University Hospital of North Norway
Helse Stavanger HF
Oslo University Hospital
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
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Identifiable resection site with colonoscopy, either by visualizing a previously administered tattoo or by identification of a scar in the correct colon segment * No other tumors or polyps larger than 10 mm in diameter in the colorectum at time of randomization * Complete colonoscopy with adequate quality of bowel preparation (Boston Bowel Preparation Scale score ≤2 in all colonic segments) and photo or video documentation of the appendiceal orifice or ileocecal valve. * No colonic strictures or severe diverticulosis. * No prior CRC * No other malignant disease which is not deemed cured * No confirmed or suspected genetic cancer syndrome (10 or more adenomas/serrated lesions, adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome) * No inflammatory bowel disease * Written informed consent provided by before enrolment
Exclusion criteria
* all who do not fulfill inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRC recurrence or sign of lymph nodes or distant metastases | 3 years | Rate of CRC recurrence or sign of lymph nodes or distant metastases |
| Severe adverse events | 30 days | Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CRC recurrence or sign of lymph nodes or distant metastases at 5 years after study treatment | 5 years | CRC recurrence or metastases |
| CRC survival and overall survival at 1,3 and 5 years after study treatment | 1, 3, 5 years | CRC survival and overall survival |
| Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 1 year after study treatment | 1 year | Severe adverse events |
| Rate of mild and moderate adverse events classified as grade I and II according to the Clavien Dindo classification at 30 days after study treatment | 30 days | mild and moderate adverse events |
| Length of hospital stay after study treatment | 30 days | Hospital stay |
| Technical success of the trial procedures, defined as completion of eFTR and surgery as planned with endoscopic complete en-bloc scar excision or complete surgical resection | 1 day | Technical success |
| Duration of the study procedure | 1 day | Duration of procedure |
| Environmental footprint of study procedures at 30 days after study treatment | 30 days | Carbon dioxide emission in kgCo2 per procedure |
| Health related quality of life and functional outcomes after 30 days and one year | 30 days, 1 year | European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (0-100 points; higher point scores mean higher QoL) |
| Hospital readmission rate after discharge within 30 days after study treatment | 30 days | Hospital readmission |
| CRC recurrence or sign of lymph nodes or distant metastases at 1 year after study treatment | 1 year | CRC recurrence or metastases |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness | 5 years | Costs in dollars as compared to effectiveness |
Countries
Norway, Poland
Contacts
Primary ContactNastazja Pilonis, MD PhD
Backup ContactMichael Bretthauer, MD PhD
Outcome results
None listed