625 Participants Needed

Nodal Sampling for Endometrial Cancer

RM
Overseen ByRachel Miller
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This study aims to estimate the recurrence-free survival rates in women with endometrial cancer treated with selective versus sentinel node surgical staging. This study will gather information to help determine the best way to evaluate lymph nodes during surgery for endometrial cancer.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on chemotherapy, hormone therapy, or immunotherapy for your endometrial cancer, you cannot participate in the trial.

What data supports the effectiveness of the treatment REFLEX, Selective surgical staging, for endometrial cancer?

Research shows that sampling lymph nodes (small glands that are part of the immune system) can help determine the spread of endometrial cancer, which is important for planning treatment. Studies suggest that this approach can improve survival outcomes by accurately assessing cancer spread, especially in high-risk cases.12345

Is nodal sampling for endometrial cancer safe for humans?

Research on sentinel lymph node sampling in endometrial cancer suggests it is generally safe, with studies focusing on its diagnostic accuracy and clinical impact. The SENTIREC-endo study specifically looks at the risks and benefits, indicating a careful evaluation of safety in its adoption.12678

How is the treatment 'Selective surgical staging' unique for endometrial cancer?

Selective surgical staging for endometrial cancer involves sampling specific lymph nodes (small glands that are part of the immune system) to check for cancer spread, which can help tailor treatment to the patient's risk level. This approach is different from more extensive surgeries that remove many lymph nodes, potentially reducing complications and recovery time.234910

Research Team

Rachel Ware Miller, MD | UK Healthcare

Rachel Miller, M.D.

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for women with endometrial cancer confined to the uterus, who can undergo surgery and have a life expectancy of at least 6 months. They should understand the study and consent to participate. Prior chemotherapy is okay if it was over five years ago with no current disease. Women must not be pregnant, have had prior pelvic lymphadenectomy or irradiation, or severe allergies to iodine/ICG.

Inclusion Criteria

AST(SGOT)/ALT(SGPT) < 3.0X upper limit of normal
Ability to understand and the willingness to sign a written informed consent document
Life expectancy (estimated survival) of at least 6 months
See 4 more

Exclusion Criteria

GOG Performance Status greater than 2 (Appendix II)
I do not have another cancer that could affect this treatment's safety or results.
Patients with psychiatric illness/social situations that would limit compliance with study requirements
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Staging

Participants undergo selective surgical staging or sentinel node procedure for lymph node evaluation

1 day
1 visit (in-person)

Follow-up

Participants are monitored for recurrence-free survival, progression-free survival, and overall survival

up to 5 years

Treatment Details

Interventions

  • REFLEX
  • Selective surgical staging
Trial Overview The study compares two surgical methods for checking lymph nodes in endometrial cancer: selective surgical staging versus sentinel node REFLEX method. It aims to find out which method is better for predicting cancer recurrence after surgery by monitoring recurrence-free survival rates.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Selective Surgical Staging with side-specific lymphadenectomy (LAD)Experimental Treatment1 Intervention
Pathologist and surgeon jointly perform the Intraoperative Consultation (IOC).
Group II: REFLEX side-specific LADActive Control1 Intervention
Sentinel node procedure

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rachel Miller

Lead Sponsor

Trials
5
Recruited
770+

Findings from Research

A systematic review of 45 studies involving 12,459 patients found only moderate agreement (67%) between preoperative endometrial sampling and final tumor grade diagnosis, indicating potential discrepancies in cancer grading.
Hysteroscopic biopsy showed the highest agreement rate (89%) with final diagnoses compared to other sampling methods, while the lowest agreement was observed for grade 2 carcinomas, highlighting the need for careful interpretation of preoperative results.
Accuracy of Endometrial Sampling in Endometrial Carcinoma: A Systematic Review and Meta-analysis.Visser, NCM., Reijnen, C., Massuger, LFAG., et al.[2022]

References

Time interval between endometrial biopsy and surgical staging for type I endometrial cancer: association between tumor characteristics and survival outcome. [2021]
Diagnostic Accuracy and Clinical Impact of Sentinel Lymph Node Sampling in Endometrial Cancer at High Risk of Recurrence: A Meta-Analysis. [2020]
Prospective validation of an intraoperative algorithm to guide surgical staging in early endometrial cancer. [2022]
Lymph node sampling and survival in endometrial cancer. [2022]
Role of lymphadenectomy in endometrial cancer with nonbulky lymph node metastasis: Comparison of comprehensive surgical staging and sentinel lymph node algorithm. [2022]
Prospective clinical trial of robotic sentinel lymph node assessment with isosulfane blue (ISB) and indocyanine green (ICG) in endometrial cancer and the impact of ultrastaging (NCT01818739). [2019]
The SENTIREC-endo study - Risks and benefits of a national adoption of sentinel node mapping in low and intermediate risk endometrial cancer. [2023]
Sentinel lymph node biopsy for stage II endometrial cancer: Recent utilization and outcome in the United States. [2022]
Accuracy of Endometrial Sampling in Endometrial Carcinoma: A Systematic Review and Meta-analysis. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Improving sentinel lymph node detection rates in endometrial cancer: how many cases are needed? [2016]
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