TerminatedNCT04970368Updated Jan 5, 2024

Comparison of Nodal Staging in Endometrial Cancer

A Phase 3 interventional study of Sentinel node procedure and Selective staging in Endometrial Cancer, sponsored by Frederick R. Ueland, M.D.. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-05.

Sponsored by Frederick R. Ueland, M.D. · Phase 3, Interventional, and Treatment

Why this study was terminated

Slow accrual

Phase: Phase 3
Study type: Interventional
Enrollment: 38
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study summary

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

Conditions studied

Endometrial Cancer

Browse trials for

Endometrial Neoplasms 1,325

Keywords

Sentinel node
Cancer
Endometrial
Intraoperative Consultation

In context

Endometrial Neoplasms

1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.

This study's enrollment of 38 is below the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.

Browse Endometrial Neoplasms studies →

Lead sponsor

Frederick R. Ueland, M.D. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

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

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

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 38 participants (actual)

Study arms

Experimental
Sentinel Node Surgical Staging
Procedure: Sentinel node procedure
Experimental
Selective Surgical Staging
Procedure: Selective staging

Interventions

ProcedureSentinel node procedure
Excision of ALL mapped nodes and other suspicious nodes regardless of mapping and label by anatomic location
ProcedureSelective staging
Intraoperative consultation (IOC)

What researchers measure

Primary outcomes

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

Secondary outcomes

Progression-free survival rate
Progress-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
Time frame: 5 years
Disease-specific survival rate
Disease-specific survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
Time frame: 5 years
Overall patient survival rate
Overall survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
Time frame: 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).
Time frame: 5 years
Patient morbidity
Time frame: 5 years
Patient mortality
Time frame: 5 years

Other outcomes

Location patterns of nodal involvement associated with staging procedures
Location patterns related to nodal involvement with staging procedures will be reported.
Time frame: 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.
Time frame: 5 years
Patterns of nodal involvement associated with primary tumor grade
Primary tumor grade related to nodal involvement will be reported
Time frame: 5 years
Patterns of nodal involvement associated with primary tumor lesion size
Primary tumor lesion size related to nodal involvement will be reported.
Time frame: 5 years
Patterns of nodal involvement associated with primary tumor depth of invasion
Primary tumor depth related to nodal involvement will be reported.
Time frame: 5 years
Patterns of nodal involvement associated with primary tumor cell type
Primary tumor cell type related to nodal involvement will be reported.
Time frame: 5 years
Location patterns of nodal involvement associated with disease stage
Location related to nodal involvement with disease stage will be reported.
Time frame: 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.
Time frame: 5 years

Study locations

1 site

University of Kentucky
Lexington, Kentucky 40506, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04970368
Lead sponsor: Frederick R. Ueland, M.D.
Responsible party: Frederick R. Ueland, M.D. (Professor, University of Kentucky) — Sponsor-investigator
First posted: Jul 21, 2021
Start date: Nov 5, 2021
Primary completion: Jun 13, 2023
Completion: Jun 13, 2023
Last update: Jan 5, 2024

Study contacts

Frederick Ueland, MD

principal investigator · University of Kentucky

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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