Comparing lymph node mapping techniques for endometrial cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial evaluates the effectiveness of sentinel lymph node mapping versus standard lymph node dissection in reducing leg swelling (lymphedema) in patients undergoing hysterectomy for stage I endometrial cancer. Participants will be randomized to receive either technique during their surgery, with the primary goal of assessing lower extremity limb dysfunction through patient-reported outcomes. Secondary objectives include measuring changes in limb circumference and validating the sentinel lymph node mapping algorithm's effectiveness. The study aims to provide insights into the long-term impacts of these surgical approaches on patient quality of life.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically proven diagnosis of endometrial cancer based on endometrial sampling with a plan to undergo laparoscopic or robotic hysterectomy and lymphatic assessment as part of primary management. Biopsy must be performed within 90 days prior to registration
* Clinical stage I endometrial cancer based on the following diagnostic workup:

  * History/physical examination within 30 days prior to registration is reassuring for the absence of metastatic disease
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
* Patients must speak English, Spanish, or Korean

Exclusion Criteria:

* Patients whom the surgeon believes is not a candidate for pelvic lymphadenectomy due to medical comorbidities or other technical challenges (i.e. morbid obesity or prior surgery)
* 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
* History of radiation to the pelvis, groin or lower extremities, or surgery to the pelvic lymph nodes or inguinal lymph nodes
* Patients who are going to undergo another elective surgery during the same operative event as their hysterectomy (i.e., sacrocolpopexy, cholecystectomy)
* Patients with severe, active co-morbidity defined as follows:

  * History of patient or provider identified lower extremity lymphedema
  * History of patient or provider identified chronic lower extremity swelling
  * History of lower extremity or pelvic deep venous thromboembolism within 90 days of registration
  * History of lower extremity cellulitis within 90 days of registration

Where it's running

• UM Sylvester Comprehensive Cancer Center at Coral Gables
  Coral Gables, Florida, United States Recruiting
• UM Sylvester Comprehensive Cancer Center at Deerfield Beach
  Deerfield Beach, Florida, United States Recruiting
• UM Sylvester Comprehensive Cancer Center at Doral
  Doral, Florida, United States Recruiting
• University of Miami Miller School of Medicine-Sylvester Cancer Center
  Miami, Florida, United States Recruiting
• UM Sylvester Comprehensive Cancer Center at Kendall
  Miami, Florida, United States Recruiting
• University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
  North Miami, Florida, United States Recruiting

+10 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Edward J Tanner — NRG Oncology

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.