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

Launched by NRG ONCOLOGY · Dec 2, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how a special technique called sentinel lymph node mapping affects the risk of swelling in the legs (lymphedema) for women with early-stage endometrial cancer, which is cancer of the lining of the uterus. The trial compares this technique to the standard method, which involves removing more lymph nodes during surgery to check for any spread of cancer. By understanding which method leads to less leg swelling after surgery, doctors hope to improve patient care and recovery.

To be eligible for the trial, participants need to be women aged 18 or older with a confirmed diagnosis of stage I endometrial cancer and planning to have a laparoscopic or robotic hysterectomy. They should be generally healthy, with no major medical issues that could complicate the surgery. Participants will be required to provide informed consent, meaning they agree to be part of the study after understanding what it involves. Throughout the trial, women will receive close monitoring to track any changes in leg swelling and overall recovery. This study is currently recruiting participants and will help shape future treatment options for women facing this type of cancer.

Gender

FEMALE

Eligibility criteria

• 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 or Spanish
• 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
• • For the bioimpedance sub study only: patients with implantable metal devices (i.e. defibrillator, metal joint replacements, etc.) will not be eligible to participate in the bioimpedance sub study but will be eligible to participate in the overall study