Effectiveness of Lymph Node Mapping to Reduce the Risk of Swelling in the Legs in Patients with Stage I Endometrial Cancer
https://www.facingourrisk.org/research-clinical-trials/study/310/effectiveness-of-lymph-node-mapping-to-reduce-the-risk-of-swelling-in-the-legs-in-patients-with-stage-i-endometrial-cancer
Clinicaltrials.gov identifier:
NCT05646316 (https://clinicaltrials.gov/show/NCT05646316)
Treatment
People with stage I endometrial cancer who are having a hysterectomy
Study Contact Information:
For additional information, please contact Dr. Edward Tanner, PI at [email protected]
About the Study
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 a specific lymph node most likely to contain cancer cells. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs.
What the Study Involves
Participants will be divided into one of two groups.
Group A: Participants will receive a special dye injected into the vein and undergo lymph node mapping and removal during a hysterectomy. Lymph nodes around the uterus may be removed if the mapping and removal cannot be completed. Successful mapping requires no additional removal of lymph nodes.
Group B: Participants will receive a special dye injected into the vein and undergo lymph node mapping and removal during a hysterectomy. Additional lymph nodes around the uterus are removed per standard of care.
Participants in both groups also undergo imaging as needed and optional blood sample collection throughout the study.
After completion of study intervention, participants are followed every 3 months for one year and at 18 and 24 months.
This Study is Open To:
People, aged 18 years and older, who meet the following criteria:
- Diagnosed with stage I endometrial cancer and plan to have a laparoscopic or robotic hysterectomy and lymphatic assessment as part of their primary management.
- Speak English or Spanish.
This Study is Not Open To:
People who are under the age of 18 and who:
- Had chemotherapy or immunotherapy for endometrial cancer except progestin-containing therapies and levonorgestrel-containing intrauterine device (IUD).
- Had radiation to the pelvis, groin, or lower extremities or surgery to lymph nodes in the pelvis or groin area.
- Will undergo another surgery at the same time as endometrial surgery.
- Have another disease or medical condition such as lower extremity lymphedema or chronic lower extremity swelling.
- Have lower extremity or pelvic deep venous thromboembolism (occurs when a blood clot breaks off and travels through the bloodstream, blocking a blood vessel) or lower extremity cellulitis (a bacterial skin infection) within 90 days of registration.
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.