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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion 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. Neoadjuvant chemotherapy for this endometrial cancer is not allowed. - 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 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Selective Surgical Staging with side-specific lymphadenectomy (LAD) 		Pathologist and surgeon jointly perform the Intraoperative Consultation (IOC).
  • Procedure: Selective surgical staging
    Intraoperative Consultation, performed by pathologist and surgeon jointly. The uterus is inspected for extra-corpus spread (cervix, parametria, adnexa, distant). The surgical pathologist will evaluate the uterus according to the IOC Worksheet and promptly notify the surgeon of the results. The IOC will include evaluation for extra-corpus disease, lesion measurement, frozen section (to confirm measured lesion is malignant, cell type, and re-grading of tumor). Non-sentinel nodes will be handled according to institutional standard-of-care practice.
Active Comparator
REFLEX side-specific LAD 		Sentinel node procedure
  • Procedure: REFLEX
    The surgeon will perform a side-specific lymphadenectomy when there is no mapping on a hemipelvis (no tracer uptake in nodes). If neither side has successful Sentinel Node mapping, the surgeon performs a complete pelvic lymphadenectomy. Surgeons will remove the para-aortic lymph nodes at their discretion.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40506
Contact:
Rachel Miller, M.D.
859-323-2169
raware00@uky.edu

More Details

NCT ID
NCT06677112
Status
Recruiting
Sponsor
Rachel Miller

Study Contact

Rachel Miller
859-323-2169
raware00@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.