Surgical Lymph Node Removal for Endometrial Cancer

Overseen By Shar Ellixson

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Frederick R. Ueland, M.D.

Disqualifiers: Extra-uterine disease, Previous irradiation, Renal abnormalities, Other malignancies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether removing specific lymph nodes during surgery can improve outcomes for patients with endometrial cancer. It focuses on determining when full lymph node removal is necessary, particularly for those with aggressive or deeply invasive cancer. The trial involves different approaches: some patients will not have lymph nodes removed, while others, identified as high risk, will undergo lymphadenectomy (removal of lymph nodes). Ideal candidates have a confirmed endometrial cancer diagnosis with no signs of cancer beyond the uterus and are eligible for specific surgeries. As an unphased study, this trial allows patients to contribute to important research that could refine surgical approaches for endometrial cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that patients should not have received chemotherapy for the present disease, so it's best to discuss your specific medications with the trial team.

What prior data suggests that this surgical technique is safe for endometrial cancer patients?

Research has shown that lymphadenectomy, the surgical removal of lymph nodes, is generally safe for people with endometrial cancer. However, it can extend the surgery and increase the risk of complications.

For those at high risk of cancer spreading to the lymph nodes, this procedure can improve cancer outcomes. Studies have found that patients undergoing this surgery often achieve good survival rates. Although the surgery can be complex, it has not been shown to negatively affect survival compared to other treatments.

Some patients might experience side effects like lymphedema, which is swelling caused by fluid buildup. However, for women with low-risk endometrial cancer, this risk remains quite low. Overall, the treatment is considered well-tolerated, especially for those with high-risk cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about lymphadenectomy for endometrial cancer because it offers a more targeted approach for high-risk patients. Unlike standard treatments that might not always involve lymph node removal, this method specifically targets and removes lymph nodes around the obturator, iliac, and aortic areas, which could help prevent cancer from spreading. By tailoring the procedure based on a patient's risk level, it aims to optimize treatment effectiveness while potentially reducing unnecessary surgeries for low-risk patients.

What evidence suggests that lymphadenectomy is effective for endometrial cancer?

Research has shown that removing lymph nodes through surgery, known as lymphadenectomy, can benefit patients with endometrial cancer, particularly those at high risk of cancer spreading to these nodes. In this trial, participants at high risk for nodal involvement will undergo lymphadenectomy, which includes the removal of obturator, iliac (internal, external, common), and aortic lymph nodes. One study found that patients who had their para-aortic lymph nodes removed had a 76% chance of being cancer-free after five years, compared to only 36% for those who did not have the surgery. Another study indicated that lymphadenectomy generally leads to better outcomes for patients likely to have cancer spread to their lymph nodes. Additionally, removing more lymph nodes was associated with a lower risk of death. This suggests that for high-risk patients, lymphadenectomy could improve survival and slow cancer progression. ^{1 2 6 7 8}

Who Is on the Research Team?

Frederick R. Ueland

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for individuals with endometrial cancer who are fit for surgery, have a life expectancy of at least 3 months, and no evidence of disease spread outside the uterus. They must not have had chemotherapy for their current cancer or any invasive cancers (except non-melanoma skin cancer) in the last five years.

Inclusion Criteria

My cancer diagnosis is endometrial cancer, and it hasn't spread outside the uterus.

Patients must have an estimated survival greater than or equal to 3 months

Patients must have signed an approved informed consent and HIPAA authorization

Exclusion Criteria

Patients with GOG Performance Grade of 3 or 4

I have a unique kidney condition that might affect surgery.

I have not had any cancer except for non-melanoma skin cancer in the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Staging

Participants undergo primary surgical staging with or without lymphadenectomy based on intraoperative consultation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for recurrence-free survival and other outcomes

24 months

Long-term Follow-up

Participants are monitored for progression-free survival, disease-specific survival, and overall survival

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Lymphadenectomy

Trial Overview The study tests a surgical procedure called lymphadenectomy during primary surgery for endometrial cancer. It aims to validate an approach that tailors surgery based on intraoperative consultation to potentially reduce risks associated with complete lymphadenectomy.

How Is the Trial Designed?

Group I: High-risk for nodal involvement Experimental Treatment 1 Intervention

Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes

Group II: Low-risk for nodal involvement Active Control 1 Intervention

No lymphadenectomy recommended

Lymphadenectomy is already approved in United States, European Union for the following indications:

Approved in United States as Lymphadenectomy for:

• Gallbladder cancer
• Other cancers requiring lymph node removal

Approved in European Union as Lymphadenectomy for:

• Gallbladder cancer
• Other cancers requiring lymph node removal

Who Is Running the Clinical Trial?

Frederick R. Ueland, M.D.

Lead Sponsor

Trials

6

Recruited

850+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3263657/

The Role of Lymphadenectomy in Surgical Staging ... The 5-year progression-free survival was 36% in those who did not undergo staging with para-aortic lymph node dissection versus 76% in those undergoing para- ...

2. nature.com nature.com/articles/s41598-025-00531-3

The impact of lymphadenectomy on cancerspecific survival ... ... lymphadenectomy is generally beneficial for the oncological outcome in endometrial cancer patients with high lymph node metastasis possibility.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10705740/

Disease-Free and Overall Survival Implications of Pelvic ... If the lymph nodes were affected bilaterally, the median patient survival was 30.10 months (CI95 [26.43; 33.76]). The 5-year OS was influenced ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090825819304974

Lymph node dissection in endometrial cancer and clinical ... Lymph node dissection was performed in 20.2%, 53.0% and 63.7% within these groups. Lymph node involvement was diagnosed in 1.7%, 9.6% and 19.3%, respectively.

5. ascopubs.org ascopubs.org/doi/10.1200/CCI.16.00064

Association of Lymph Node Count and Overall Survival in ... Conclusion. Increased lymph node count is associated with a 1% to 14% decreased hazard of death per each additional five lymph nodes removed ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24016232

Long-term survival outcomes in high-risk endometrial ... Disease-free survival (85.2% vs 82.8%; p=0.74) and overall survival (91.3% vs 92.6%; p=0.62) were not different between the sentinel lymph node alone and ...

7. ejgo.org ejgo.org/DOIx.php?id=10.3802/jgo.2024.35.e29

Sentinel node mapping in endometrial cancer Among, node negative patients (n=168) the-adjusted 3-year recurrence free survival rates were 73% after sentinel node mapping and 91% after ...

8. ajog.org ajog.org/article/S0002-9378(24)00904-9/fulltext

Patient-reported lymphedema after sentinel lymph node ... Women with low-grade endometrial cancer have a low risk of lymphedema after sentinel lymph node mapping. Leg swelling at baseline and body mass ...