Comparison of Nodal Staging in Endometrial Cancer
Study Details
Study Description
Brief Summary
This study aims to estimate the recurrence-free survival rates in women with endometrial cancer treated with selective versus sentinel node surgical staging.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sentinel Node Surgical Staging
|
Procedure: Sentinel node procedure
Excision of ALL mapped nodes and other suspicious nodes regardless of mapping and label by anatomic location
|
| Experimental: Selective Surgical Staging
|
Procedure: Selective staging
Intraoperative consultation (IOC)
|
Outcome Measures
Primary Outcome Measures
- Recurrence-free survival rate [5 years]
Recurrence-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
Secondary Outcome Measures
- Progression-free survival rate [5 years]
Progress-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
- Disease-specific survival rate [5 years]
Disease-specific survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
- Overall patient survival rate [5 years]
Overall survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
- Concordance of SELECTIVE and SENTINEL NODE surgical staging with final pathology [5 years]
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).
- Patient morbidity [5 years]
- Patient mortality [5 years]
Other Outcome Measures
- Location patterns of nodal involvement associated with staging procedures [5 years]
Location patterns related to nodal involvement with staging procedures will be reported.
- Number of metastatic lymph node(s) associated with staging procedures [5 years]
The number of metastatic lymph node(s) associated with the staging procedures will be reported.
- Patterns of nodal involvement associated with primary tumor grade [5 years]
Primary tumor grade related to nodal involvement will be reported
- Patterns of nodal involvement associated with primary tumor lesion size [5 years]
Primary tumor lesion size related to nodal involvement will be reported.
- Patterns of nodal involvement associated with primary tumor depth of invasion [5 years]
Primary tumor depth related to nodal involvement will be reported.
- Patterns of nodal involvement associated with primary tumor cell type [5 years]
Primary tumor cell type related to nodal involvement will be reported.
- Location patterns of nodal involvement associated with disease stage [5 years]
Location related to nodal involvement with disease stage will be reported.
- Number of metastatic lymph node(s) associated with disease stage [5 years]
The number of metastatic lymph node(s) associated with the staging procedures will be reported.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Kentucky | Lexington | Kentucky | United States | 40506 |
Sponsors and Collaborators
- Frederick R. Ueland, M.D.
Investigators
- Principal Investigator: Frederick Ueland, MD, University of Kentucky
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MCC-21-GYN-210