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

Rachel Miller1 site in 1 country625 target enrollmentMarch 17, 2025

ConditionsEndometrial Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Endometrial Cancer
Sponsor: Rachel Miller
Enrollment: 625
Locations: 1
Primary Endpoint: Recurrence free survival
Status: Recruiting
Last Updated: 5 months 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. This study will gather information to help determine the best way to evaluate lymph nodes during surgery for endometrial cancer.

Registry

clinicaltrials.gov

Start Date

March 17, 2025

End Date

January 1, 2030

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Rachel Miller

Responsible Party

Sponsor Investigator

Principal Investigator

Rachel Miller

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 carcinoma of the endometrium confined to the uterine corpus
•No clinical evidence of extra-uterine disease on pre-operative evaluation. Preoperative evaluation to rule-out extra-uterine disease may include a CT scan, MRI or ultrasound. Note: preoperative imaging is not mandatory for study enrollment.
•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.
•Neoadjuvant chemotherapy for this endometrial cancer is not allowed.
•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 Performance Status greater than 2 (Appendix II)
•Uterine sarcoma
•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 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 should be excluded
•Known allergy to iodine or indocyanine 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

Time Frame: up to 5 years

Participants with no measurable disease from study entry until disease recurrence, death, or date of the last contact

Secondary Outcomes

Concordance between selective surgical staging and final pathology Incidence(5 years)
Progression-free survival(up to 5 years)
Disease-specific Survival(up to 5 years)
Overall patient survival rate(5 years)