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

401 Participants Needed

Trial Summary

What is the purpose of this trial?

Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical staging for endometrial cancer increases operative time and surgical morbidity, but appears to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic approach has not been reproduced, and the investigators propose to validate their algorithm at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the investigators are well-suited to perform this investigation. A surgical approach that is tailored to the patient's cancer biology is rational, supported by the recent literature, and medically compelling since the co-morbidities of many obese, low-risk EC patients put them at significantly increased perioperative risk for complete lymphadenectomy.

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 data supports the effectiveness of the treatment Lymphadenectomy, Lymph node dissection, Lymph node removal for endometrial cancer?

Research suggests that removing more lymph nodes during surgery for endometrial cancer may improve survival rates and reduce the risk of cancer coming back. However, the role of lymph node removal in treatment is still debated, and more studies are needed to confirm its benefits. ^{1 2 3 4 5}

Is lymph node removal surgery generally safe for humans?

Lymph node removal surgery, also known as lymphadenectomy, can have risks such as an increased chance of blood clots after surgery and long-term complications. It's important to discuss these risks with your doctor to understand how they might apply to you. ^{6 7 8 9 10}

How does lymphadenectomy differ from other treatments for endometrial cancer?

Lymphadenectomy (lymph node removal) is unique because it involves surgically removing lymph nodes to check for cancer spread, which helps in staging the cancer and tailoring further treatment. Unlike other treatments, it provides direct information about lymph node involvement, which is crucial for determining the extent of the disease and planning additional therapies. ^{3 4 10 11 12}

Research Team

Frederick R. Ueland

Principal Investigator

University of Kentucky

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Impact of lymphadenectomy on short- and long-term complications in patients with endometrial cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Does Lymph Node Dissection Impact Adjuvant Treatment or Survival Outcomes in High-Risk Endometrial Cancers? [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Staging for endometrial cancer: The controversy around lymphadenectomy - Can this be resolved? [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Lymphadenectomy during endometrial cancer staging: practice patterns among gynecologic oncologists. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Disease-Free and Overall Survival Implications of Pelvic Lymphadenectomy in Endometrial Cancer: A Retrospective Population-Based Single-Center Study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Obesity, lymphadenectomy and survival outcomes in intermediate to high-risk, early-stage endometrial cancer patients. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Lymphadenectomy is associated with an increased risk of postoperative venous thromboembolism in early stage endometrial cancer. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Long term complications following pelvic and para-aortic lymphadenectomy for endometrial cancer, incidence and potential risk factors: a single institution experience. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term survival of a patient with stage IIIC2 grade 3 endometrioid endometrial carcinoma treated with surgery alone. [2022]

10. France pubmed.ncbi.nlm.nih.gov

[Lymph node dissection in the surgical management of stage I endometrial carcinomas]. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Is lymph node dissection mandatory among early stage endometrial cancer patients? A retrospective study. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Current and future surgical approaches in the management of endometrial carcinoma. [2008]