Comparison of Nodal Staging in Endometrial Cancer

Last updated: January 3, 2024
Sponsor: Frederick R. Ueland, M.D.
Overall Status: Terminated

Phase

3

Condition

Endometrial Cancer

Endometriosis

Pelvic Cancer

Treatment

Sentinel node procedure

Selective staging

Clinical Study ID

NCT04970368
MCC-21-GYN-210
  • Ages > 18
  • 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Surgical candidate for complete hysterectomy and bilateral salpingooophorectomy withpelvic and aortic lymphadenectomy
  • Histologically or cytologically confirmed endometrioid-type endometrial cancerconfined 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 tostudy 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

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 ofsuspicious 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 hasthe potential to interfere with the safety or efficacy assessment of theinvestigational regimen
  • Known allergy to iodine or indigocyanine green (ICG) tracer, or allergic reactions tocompounds of similar chemical or biologic composition
  • Patients with uncontrolled intercurrent illness
  • Patients with psychiatric illness/social situations that would limit compliance withstudy requirements
  • Pregnant or lactating women

Study Design

Total Participants: 38
Treatment Group(s): 2
Primary Treatment: Sentinel node procedure
Phase: 3
Study Start date:
November 05, 2021
Estimated Completion Date:
June 13, 2023

Connect with a study center

  • University of Kentucky

    Lexington, Kentucky 40506
    United States

    Site Not Available

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