Comparison of Nodal Staging in Endometrial Cancer

January 3, 2024 updated by: Frederick R. Ueland, M.D.

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Frederick Ueland, MD
  • Phone Number: 857-257-1613
  • Email: fuela0@uky.edu

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recurrence-free survival rate
Time Frame: 5 years
Recurrence-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free survival rate
Time Frame: 5 years
Progress-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
5 years
Disease-specific survival rate
Time Frame: 5 years
Disease-specific survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
5 years
Overall patient survival rate
Time Frame: 5 years
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
Time Frame: 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).
5 years
Patient morbidity
Time Frame: 5 years
5 years
Patient mortality
Time Frame: 5 years
5 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Location patterns of nodal involvement associated with staging procedures
Time Frame: 5 years
Location patterns related to nodal involvement with staging procedures will be reported.
5 years
Number of metastatic lymph node(s) associated with staging procedures
Time Frame: 5 years
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
Time Frame: 5 years
Primary tumor grade related to nodal involvement will be reported
5 years
Patterns of nodal involvement associated with primary tumor lesion size
Time Frame: 5 years
Primary tumor lesion size related to nodal involvement will be reported.
5 years
Patterns of nodal involvement associated with primary tumor depth of invasion
Time Frame: 5 years
Primary tumor depth related to nodal involvement will be reported.
5 years
Patterns of nodal involvement associated with primary tumor cell type
Time Frame: 5 years
Primary tumor cell type related to nodal involvement will be reported.
5 years
Location patterns of nodal involvement associated with disease stage
Time Frame: 5 years
Location related to nodal involvement with disease stage will be reported.
5 years
Number of metastatic lymph node(s) associated with disease stage
Time Frame: 5 years
The number of metastatic lymph node(s) associated with the staging procedures will be reported.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Frederick R. Ueland, M.D.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frederick Ueland, MD, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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