Comparison of Nodal Staging in Endometrial Cancer

Study Overview
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Brief Summary
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This study aims to estimate the recurrence-free survival rates in women with endometrial cancer treated with selective versus sentinel node surgical staging.

Official Title
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Randomized Phase 3 Study of Selective Versus Sentinel Node Surgical Staging for the Treatment of Endometrial Cancer

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Procedure: Sentinel node procedure
* Procedure: Selective staging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Surgical candidate for complete hysterectomy and bilateral salpingooophorectomy with pelvic and aortic lymphadenectomy Histologically or cytologically confirmed endometrioid-type endometrial cancer confined to the uterine corpus No clinical evidence of extra-uterine disease on pre-operative evaluation. Prior systemic chemotherapy is allowed so long as it was at least five years prior to study enrollment, and there is no evidence of disease after such therapy. Age ≥18 years. Life expectancy (estimated survival) of at least 6 months. AST(SGOT)/ALT(SGPT) < 3.0X upper limit of normal Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: GOG/ECOG Performance Status greater than 2 Non-endometrioid cell type Clinical evidence of disease that extends beyond the uterus, including the presence of suspicious aortic or inguinal nodes on imaging or clinical exam Previous vaginal, pelvic or abdominal irradiation Chemotherapy, hormone therapy or immunotherapy directed at the present disease Previous pelvic lymphadenectomy or retroperitoneal surgery Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen Known allergy to iodine or indigocyanine green (ICG) tracer, or allergic reactions to compounds of similar chemical or biologic composition Patients with uncontrolled intercurrent illness Patients with psychiatric illness/social situations that would limit compliance with study requirements Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sentinel Node Surgical Staging<br> | Procedure: Sentinel node procedure<br>* Excision of ALL mapped nodes and other suspicious nodes regardless of mapping and label by anatomic location<br>|
| Experimental: Selective Surgical Staging<br> | Procedure: Selective staging<br>* Intraoperative consultation (IOC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival rate | Recurrence-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival rate | Progress-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging | 5 years | 
| Disease-specific survival rate | Disease-specific survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging | 5 years | 
| Overall patient survival rate | Overall survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging | 5 years | 
| Concordance of SELECTIVE and SENTINEL NODE surgical staging with final pathology | Percentage of participants for whom selective surgical staging and final pathology match. Match incorporates grade, lesion size, depth of invasion, and low-risk (no lymphadenectomy) versus high-risk (lymphadenectomy). | 5 years | 
| Patient morbidity |  | 5 years | 
| Patient mortality |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sentinel node, Cancer, Endometrial, Intraoperative Consultation