Randomized Phase 3 Study of SELECTIVE SURGICAL STAGING Versus REFLEX Lymphadenectomy in Non-mappers Undergoing Sentinel Lymph Node Sampling for the Treatment of Endometrial Cancer
Summary
This study aims to estimate the recurrence-free survival rates in women with endometrial cancer treated with selective versus sentinel node surgical staging. This study will gather information to help determine the best way to evaluate lymph nodes during surgery for endometrial cancer.
Arms & interventions
- ProcedureSelective surgical staging
Intraoperative Consultation, performed by pathologist and surgeon jointly. The uterus is inspected for extra-corpus spread (cervix, parametria, adnexa, distant). The surgical pathologist will evaluate the uterus according to the IOC Worksheet and promptly notify the surgeon of the results. The IOC will include evaluation for extra-corpus disease, lesion measurement, frozen section (to confirm measured lesion is malignant, cell type, and re-grading of tumor). Non-sentinel nodes will be handled according to institutional standard-of-care practice.
- ProcedureREFLEX
The surgeon will perform a side-specific lymphadenectomy when there is no mapping on a hemipelvis (no tracer uptake in nodes). If neither side has successful Sentinel Node mapping, the surgeon performs a complete pelvic lymphadenectomy. Surgeons will remove the para-aortic lymph nodes at their discretion.
Outcome measures
Primary
Recurrence free survival
Participants with no measurable disease from study entry until disease recurrence, death, or date of the last contact
Time frame: up to 5 years
Secondary
Concordance between selective surgical staging and final pathology Incidence
Time frame: 5 years
Progression-free survival
Time frame: up to 5 years
Disease-specific Survival
Time frame: up to 5 years
Overall patient survival rate
Time frame: 5 years
Eligibility criteria
Study locations (1)
University of Kentucky
Lexington, Kentucky, 40506