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

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Rachel Miller
Study ID
NCT06677112
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selective surgical staging — PROCEDURE
    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.
  • REFLEX — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Mar 17, 2025
Status verified
Nov 2025
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
625 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Selective Surgical Staging with side-specific lymphadenectomy (LAD)
    Pathologist and surgeon jointly perform the Intraoperative Consultation (IOC).
  • Active Comparator: REFLEX side-specific LAD
    Sentinel node procedure

Primary Outcome Measure

Recurrence free survival [ Time Frame: up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40506
Rachel Miller, M.D.
[email protected]
859-323-2169

Find similar trials in Lexington, KY

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Kentucky· Lexington, KY

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