Sentinel Node Biopsy in Endometrial Cancer Trial
Phase 3
760
about 10 years
18+
Female only
1 site in TX
What this study is about
This trial is testing whether sentinel node biopsy (SNB) is as good as not removing lymph nodes after surgery for endometrial cancer. The goal is to see if SNB helps women return to their normal activities and doesn't cause more harm than no lymph node removal.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Undergo TH BSO with SNB Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted
- 2.Undergo TH BSO without retroperitoneal node dissection Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Stage 2: Disease Free Survival
Secondary: Cost Effectiveness measuring GP and specialist consultations, Cost Effectiveness measuring Intervention costs, Cost Effectiveness measuring community and health service requirements and days off work and informal care required by family and friends using a combination of the Health Services Questionnaire and clinical files, Cost Effectiveness measuring prescriptions and over the counter medicine requirements, Cost Effectiveness measuring radiology and imaging requirements, Cost Effectiveness using QALYs using EuroQoL-5D (EQ-5D) Questionnaire, Cost Effectiveness: direct costs using a bottom-up approach by recording the volume of resource use in both groups of the trial, and then applying a unit cost to each component, Health Related Quality of Life and Fear of Recurrence
Oncology