Endometrial Cancer
Conditions
Keywords
Sentinel node, Cancer, Endometrial, Intraoperative Consultation
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.
Interventions
PROCEDURESentinel node procedure
Excision of ALL mapped nodes and other suspicious nodes regardless of mapping and label by anatomic location
PROCEDURESelective staging
Intraoperative consultation (IOC)
Sponsors
Frederick R. Ueland, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free survival rate | 5 years | Recurrence-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival rate | 5 years | Progress-free 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 |
| Disease-specific survival rate | 5 years | Disease-specific survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging |
| Patient morbidity | 5 years | — |
| Patient mortality | 5 years | — |
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 disease stage | 5 years | The number of metastatic lymph node(s) associated with the 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. |
Countries
United States
Outcome results
None listed