Clinical trial NCT04970368: Comparison of Nodal Staging in Endometrial Cancer
Official title: Randomized Phase 3 Study of Selective Versus Sentinel Node Surgical Staging for the Treatment of Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Endometrial Cancer
Keywords: Sentinel node
Cancer
Endometrial
Intraoperative Consultation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Recurrence-free survival rate
timeFrame: 5 years
Secondary outcomes:
measure: Progression-free survival rate
timeFrame: 5 years
measure: Disease-specific survival rate
timeFrame: 5 years
measure: Overall patient survival rate
timeFrame: 5 years
measure: Concordance of SELECTIVE and SENTINEL NODE surgical staging with final pathology
timeFrame: 5 years
measure: Patient morbidity
timeFrame: 5 years
measure: Patient mortality
timeFrame: 5 years
Other outcomes:
measure: Location patterns of nodal involvement associated with staging procedures
timeFrame: 5 years
measure: Number of metastatic lymph node(s) associated with staging procedures
timeFrame: 5 years
measure: Patterns of nodal involvement associated with primary tumor grade
timeFrame: 5 years
measure: Patterns of nodal involvement associated with primary tumor lesion size
timeFrame: 5 years
measure: Patterns of nodal involvement associated with primary tumor depth of invasion
timeFrame: 5 years
measure: Patterns of nodal involvement associated with primary tumor cell type
timeFrame: 5 years
measure: Location patterns of nodal involvement associated with disease stage
timeFrame: 5 years
measure: Number of metastatic lymph node(s) associated with disease stage
timeFrame: 5 years
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Frederick Ueland, MD
role: PRINCIPAL_INVESTIGATOR
References: