Comparison of Nodal Staging in Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04970368
• Other study ID #: MCC-21-GYN-210
• Status: Terminated
• Phase: Phase 3
• Start date: November 5, 2021
• Est. completion date: June 13, 2023

Study information

• Verified date: January 2024
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: June 13, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Procedure:
• Sentinel node procedure
Excision of ALL mapped nodes and other suspicious nodes regardless of mapping and label by anatomic location
• Selective staging
Intraoperative consultation (IOC)

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Frederick R. Ueland, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Location patterns of nodal involvement associated with staging procedures	Location patterns related to nodal involvement with staging procedures will be reported.	5 years
Other	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
Other	Patterns of nodal involvement associated with primary tumor grade	Primary tumor grade related to nodal involvement will be reported	5 years
Other	Patterns of nodal involvement associated with primary tumor lesion size	Primary tumor lesion size related to nodal involvement will be reported.	5 years
Other	Patterns of nodal involvement associated with primary tumor depth of invasion	Primary tumor depth related to nodal involvement will be reported.	5 years
Other	Patterns of nodal involvement associated with primary tumor cell type	Primary tumor cell type related to nodal involvement will be reported.	5 years
Other	Location patterns of nodal involvement associated with disease stage	Location related to nodal involvement with disease stage will be reported.	5 years
Other	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
Primary	Recurrence-free survival rate	Recurrence-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging	5 years
Secondary	Progression-free survival rate	Progress-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging	5 years
Secondary	Disease-specific survival rate	Disease-specific survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging	5 years
Secondary	Overall patient survival rate	Overall survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging	5 years
Secondary	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
Secondary	Patient morbidity		5 years
Secondary	Patient mortality		5 years