Comparison of Nodal Staging in Endometrial Cancer

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

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

Study Overview

• Status: Terminated
• Conditions: Endometrial Cancer
• Intervention / Treatment: Procedure: Sentinel node procedure; Procedure: Selective staging

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University Of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sentinel Node Surgical Staging	Procedure: Sentinel node procedure; Excision of ALL mapped nodes and other suspicious nodes regardless of mapping and label by anatomic location
Experimental: Selective Surgical Staging	Procedure: Selective staging; Intraoperative consultation (IOC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence-free survival rate	Recurrence-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival rate	Progress-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging	5 years
Disease-specific survival rate	Disease-specific survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging	5 years
Overall patient survival rate	Overall survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging	5 years
Concordance of SELECTIVE and SENTINEL NODE surgical staging with final pathology	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).	5 years
Patient morbidity		5 years
Patient mortality		5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Location patterns of nodal involvement associated with staging procedures	Location patterns related to nodal involvement with staging procedures will be reported.	5 years
Number of metastatic lymph node(s) associated with staging procedures	The number of metastatic lymph node(s) associated with the staging procedures will be reported.	5 years
Patterns of nodal involvement associated with primary tumor grade	Primary tumor grade related to nodal involvement will be reported	5 years
Patterns of nodal involvement associated with primary tumor lesion size	Primary tumor lesion size related to nodal involvement will be reported.	5 years
Patterns of nodal involvement associated with primary tumor depth of invasion	Primary tumor depth related to nodal involvement will be reported.	5 years
Patterns of nodal involvement associated with primary tumor cell type	Primary tumor cell type related to nodal involvement will be reported.	5 years
Location patterns of nodal involvement associated with disease stage	Location related to nodal involvement with disease stage will be reported.	5 years
Number of metastatic lymph node(s) associated with disease stage	The number of metastatic lymph node(s) associated with the staging procedures will be reported.	5 years

Collaborators and Investigators

• Sponsor: Frederick R. Ueland, M.D.
• Investigators: Principal Investigator: Frederick Ueland, MD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2021
• Primary Completion (Actual): June 13, 2023
• Study Completion (Actual): June 13, 2023

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Sentinel node; Endometrial; Intraoperative Consultation
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometrial Neoplasms
• Other Study ID Numbers: MCC-21-GYN-210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No