Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer

Summary

This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection removes lymph nodes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby lymph nodes. Sentinel lymph node mapping uses a special dye and camera to look for cancer that may have spread to nearby lymph nodes. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs.

Conditions

• Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Diagnostic Imaging Testing

Undergo imaging

PROCEDURE

Excisional Biopsy

Undergo sentinel lymph node excision

DRUG

Indocyanine Green Solution

Given via injection

PROCEDURE

Minimally Invasive Surgery

Undergo minimally invasive hysterectomy

PROCEDURE

Pelvic Lymphadenectomy

Undergo pelvic lymphadenectomy

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Sentinel Lymph Node Mapping

Undergo sentinel lymph node mapping

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• NRG Oncology

  lead OTHER

Principal Investigators

• Edward J Tanner · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-07

Primary Completion

2026-10-31

Completion

2026-10-31

Countries

• United States

Study Locations