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Comparison of Nodal Staging in Endometrial Cancer

Primary Purpose

Endometrial Cancer

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sentinel node procedure
Selective staging
Sponsored by
Frederick R. Ueland, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring Sentinel node, Cancer, Endometrial, Intraoperative Consultation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University of KentuckyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sentinel Node Surgical Staging

Selective Surgical Staging

Arm Description

Outcomes

Primary Outcome Measures

Recurrence-free survival rate
Recurrence-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging

Secondary Outcome Measures

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

Full Information

First Posted
June 25, 2021
Last Updated
December 19, 2022
Sponsor
Frederick R. Ueland, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT04970368
Brief Title
Comparison of Nodal Staging in Endometrial Cancer
Official Title
Randomized Phase 3 Study of Selective Versus Sentinel Node Surgical Staging for the Treatment of Endometrial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2021 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Frederick R. Ueland, M.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
Sentinel node, Cancer, Endometrial, Intraoperative Consultation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sentinel Node Surgical Staging
Arm Type
Experimental
Arm Title
Selective Surgical Staging
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Sentinel node procedure
Intervention Description
Excision of ALL mapped nodes and other suspicious nodes regardless of mapping and label by anatomic location
Intervention Type
Procedure
Intervention Name(s)
Selective staging
Intervention Description
Intraoperative consultation (IOC)
Primary Outcome Measure Information:
Title
Recurrence-free survival rate
Description
Recurrence-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Progression-free survival rate
Description
Progress-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
Time Frame
5 years
Title
Disease-specific survival rate
Description
Disease-specific survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
Time Frame
5 years
Title
Overall patient survival rate
Description
Overall survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
Time Frame
5 years
Title
Concordance of SELECTIVE and SENTINEL NODE surgical staging with final pathology
Description
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
Title
Patient morbidity
Time Frame
5 years
Title
Patient mortality
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Location patterns of nodal involvement associated with staging procedures
Description
Location patterns related to nodal involvement with staging procedures will be reported.
Time Frame
5 years
Title
Number of metastatic lymph node(s) associated with staging procedures
Description
The number of metastatic lymph node(s) associated with the staging procedures will be reported.
Time Frame
5 years
Title
Patterns of nodal involvement associated with primary tumor grade
Description
Primary tumor grade related to nodal involvement will be reported
Time Frame
5 years
Title
Patterns of nodal involvement associated with primary tumor lesion size
Description
Primary tumor lesion size related to nodal involvement will be reported.
Time Frame
5 years
Title
Patterns of nodal involvement associated with primary tumor depth of invasion
Description
Primary tumor depth related to nodal involvement will be reported.
Time Frame
5 years
Title
Patterns of nodal involvement associated with primary tumor cell type
Description
Primary tumor cell type related to nodal involvement will be reported.
Time Frame
5 years
Title
Location patterns of nodal involvement associated with disease stage
Description
Location related to nodal involvement with disease stage will be reported.
Time Frame
5 years
Title
Number of metastatic lymph node(s) associated with disease stage
Description
The number of metastatic lymph node(s) associated with the staging procedures will be reported.
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frederick Ueland, MD
Phone
857-257-1613
Email
fuela0@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick Ueland, MD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederick Ueland, MD
Phone
859-257-1613
Email
fuela0@uky.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Nodal Staging in Endometrial Cancer

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