Comparison of Nodal Staging in Endometrial Cancer

Frederick R. Ueland, M.D.

Status and phase

Terminated

Phase 3

Conditions

Endometrial Cancer

Treatments

Procedure: Sentinel node procedure

Procedure: Selective staging

Study type

Interventional

Funder types

Other

Identifiers

NCT04970368

MCC-21-GYN-210

Details and patient eligibility

About

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

Enrollment

38 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Pregnant or lactating women