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OncoMatch/Clinical Trials/NCT05646316

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

Is NCT05646316 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Indocyanine Green Solution for stage i uterine corpus carcinoma or carcinosarcoma ajcc v8.

Phase 3RecruitingNRG OncologyNCT05646316Data as of May 2026

Treatment: Indocyanine Green SolutionThis 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.

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Extracted eligibility criteria

Disease stage

Required: Stage I

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)

Cannot have received: chemotherapy

Exception: progestin-containing therapies such as megestrol, medroxyprogesterone, or levonorgestrel-containing intrauterine device (IUD) are acceptable

History of chemotherapy or immunotherapy for the treatment of endometrial cancer. Progestin-containing therapies such as megestrol, medroxyprogesterone, or levonorgestrel-containing intrauterine device (IUD) are acceptable

Cannot have received: immunotherapy

Exception: progestin-containing therapies such as megestrol, medroxyprogesterone, or levonorgestrel-containing intrauterine device (IUD) are acceptable

History of chemotherapy or immunotherapy for the treatment of endometrial cancer. Progestin-containing therapies such as megestrol, medroxyprogesterone, or levonorgestrel-containing intrauterine device (IUD) are acceptable

Cannot have received: radiation therapy

History of radiation to the pelvis, groin or lower extremities

Cannot have received: surgery

surgery to the pelvic lymph nodes or inguinal lymph nodes

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • George Washington University Medical Center · Washington D.C., District of Columbia
  • UM Sylvester Comprehensive Cancer Center at Coral Gables · Coral Gables, Florida
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach · Deerfield Beach, Florida
  • UM Sylvester Comprehensive Cancer Center at Doral · Doral, Florida
  • University of Miami Miller School of Medicine-Sylvester Cancer Center · Miami, Florida

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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