NCT04970368

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

November 5, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2023

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

1.6 years

First QC Date

June 25, 2021

Last Update Submit

January 3, 2024

Conditions

Endometrial Cancer

Keywords

Sentinel nodeCancerEndometrialIntraoperative Consultation

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free survival rate

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

    5 years

Secondary Outcomes (6)

  • Progression-free survival rate

    5 years

  • Disease-specific survival rate

    5 years

  • Overall patient survival rate

    5 years

  • Concordance of SELECTIVE and SENTINEL NODE surgical staging with final pathology

    5 years

  • Patient morbidity

    5 years

  • +1 more secondary outcomes

Other Outcomes (8)

  • Location patterns of nodal involvement associated with staging procedures

    5 years

  • Number of metastatic lymph node(s) associated with staging procedures

    5 years

  • Patterns of nodal involvement associated with primary tumor grade

    5 years

  • +5 more other outcomes

Study Arms (2)

Sentinel Node Surgical Staging

EXPERIMENTAL
Procedure: Sentinel node procedure

Selective Surgical Staging

EXPERIMENTAL
Procedure: Selective staging

Interventions

Sentinel node procedurePROCEDURE

Excision of ALL mapped nodes and other suspicious nodes regardless of mapping and label by anatomic location

Sentinel Node Surgical Staging
Selective stagingPROCEDURE

Intraoperative consultation (IOC)

Selective Surgical Staging

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Endometrial NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Frederick Ueland, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 25, 2021

First Posted

July 21, 2021

Study Start

November 5, 2021

Primary Completion

June 13, 2023

Study Completion

June 13, 2023

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)