MCC-24-GYN-11: Comparison of Nodal Sampling in Endometrial Cancer

Description

This study aims to estimate the recurrence-free survival rates in women with endometrial cancer treated with selective versus sentinel node surgical staging. This study will gather information to help determine the best way to evaluate lymph nodes during surgery for endometrial cancer.

Conditions

Endometrial Cancer

Study Overview

Study Details

Study overview

This study aims to estimate the recurrence-free survival rates in women with endometrial cancer treated with selective versus sentinel node surgical staging. This study will gather information to help determine the best way to evaluate lymph nodes during surgery for endometrial cancer.

Randomized Phase 3 Study of SELECTIVE SURGICAL STAGING Versus REFLEX Lymphadenectomy in Non-mappers Undergoing Sentinel Lymph Node Sampling for the Treatment of Endometrial Cancer

MCC-24-GYN-11: Comparison of Nodal Sampling in Endometrial Cancer

Condition
Endometrial Cancer
Intervention / Treatment

-

Contacts and Locations

Lexington

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Surgical candidate for complete hysterectomy and bilateral salpingooophorectomy with pelvic and aortic lymphadenectomy
  • * Histologically or cytologically confirmed carcinoma of the endometrium confined to the uterine corpus
  • * No clinical evidence of extra-uterine disease on pre-operative evaluation. Preoperative evaluation to rule-out extra-uterine disease may include a CT scan, MRI or ultrasound. Note: preoperative imaging is not mandatory for study enrollment.
  • * 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.
  • * 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
  • * GOG Performance Status greater than 2 (Appendix II)
  • * Uterine sarcoma
  • * 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 should be excluded
  • * Known allergy to iodine or indocyanine 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. Women of child-bearing potential will be excluded if they have a positive serum/urine pregnancy test

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rachel Miller,

Rachel Miller, M.D., PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

2030-01