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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
625
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.
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.
University of Kentucky
Lexington, Kentucky, United States
RECRUITINGRecurrence 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
Concordance between selective surgical staging and final pathology Incidence
Percentage of participants for whom selective surgical staging and final pathology match
Time frame: 5 years
Progression-free survival
period from study entry until disease progression, death, or date of the last contact
Time frame: up to 5 years
Disease-specific Survival
period from study entry until death from the disease (endometrial cancer)
Time frame: up to 5 years
Overall patient survival rate
period from study entry until death from any cause
Time frame: 5 years
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