Comparison of Nodal Staging in Endometrial Cancer

Phase 3

Terminated

• Conditions: Endometrial Cancer
• Interventions: Procedure: Selective staging; Procedure: Sentinel node procedure

• Registration Number: NCT04970368
• Lead Sponsor: Frederick R. Ueland, M.D.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-25
• Study First Submitted QC: 2021-07-09
• Study First Posted: 2021-07-21
• Study Start: 2021-11-05
• Primary Completion: 2023-06-13
• Study Completion: 2023-06-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Selective Surgical Staging	Selective staging	-
Sentinel Node Surgical Staging	Sentinel node procedure	-

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival rate	5 years	Recurrence-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging

Secondary Outcome Measures

Name	Time	Method
Concordance of SELECTIVE and SENTINEL NODE surgical staging with final pathology	5 years	Percentage of participants for whom selective surgical staging and final pathology match. Match incorporates grade, lesion size, depth of invasion, and low-risk (no lymphadenectomy) versus high-risk (lymphadenectomy).
Disease-specific survival rate	5 years	Disease-specific survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
Patient mortality	5 years
Patient morbidity	5 years
Progression-free survival rate	5 years	Progress-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
Overall patient survival rate	5 years	Overall survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States