Randomized Phase 3 Study of Selective Versus Sentinel Node Surgical Staging for the Treatment of Endometrial Cancer

Frederick R. Ueland, M.D.1 site in 1 country38 target enrollmentNovember 5, 2021

ConditionsEndometrial Cancer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Endometrial Cancer
Sponsor: Frederick R. Ueland, M.D.
Enrollment: 38
Locations: 1
Primary Endpoint: Recurrence-free survival rate
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to estimate the recurrence-free survival rates in women with endometrial cancer treated with selective versus sentinel node surgical staging.

Registry

clinicaltrials.gov

Start Date

November 5, 2021

End Date

June 13, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Frederick R. Ueland, M.D.

Responsible Party

Sponsor Investigator

Principal Investigator

Frederick R. Ueland, M.D.

Professor

University of Kentucky

Eligibility Criteria

Inclusion Criteria

•Surgical candidate for complete hysterectomy and bilateral salpingooophorectomy with pelvic and aortic lymphadenectomy
•Histologically or cytologically confirmed endometrioid-type endometrial cancer confined to the uterine corpus
•No clinical evidence of extra-uterine disease on pre-operative evaluation.
•Prior systemic chemotherapy is allowed so long as it was at least five years prior to study enrollment, and there is no evidence of disease after such therapy.
•Age ≥18 years.
•Life expectancy (estimated survival) of at least 6 months.
•AST(SGOT)/ALT(SGPT) \< 3.0X upper limit of normal
•Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

•GOG/ECOG Performance Status greater than 2
•Non-endometrioid cell type
•Clinical evidence of disease that extends beyond the uterus, including the presence of suspicious aortic or inguinal nodes on imaging or clinical exam
•Previous vaginal, pelvic or abdominal irradiation
•Chemotherapy, hormone therapy or immunotherapy directed at the present disease
•Previous pelvic lymphadenectomy or retroperitoneal surgery
•Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
•Known allergy to iodine or indigocyanine green (ICG) tracer, or allergic reactions to compounds of similar chemical or biologic composition
•Patients with uncontrolled intercurrent illness
•Patients with psychiatric illness/social situations that would limit compliance with study requirements

Outcomes

Primary Outcomes

Recurrence-free survival rate

Time Frame: 5 years

Recurrence-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging

Secondary Outcomes

Concordance of SELECTIVE and SENTINEL NODE surgical staging with final pathology(5 years)
Disease-specific survival rate(5 years)
Patient mortality(5 years)
Patient morbidity(5 years)
Progression-free survival rate(5 years)
Overall patient survival rate(5 years)