Clinical trial NCT06677112: MCC-24-GYN-11: Comparison of Nodal Sampling in Endometrial Cancer
Official title: Randomized Phase 3 Study of SELECTIVE SURGICAL STAGING Versus REFLEX Lymphadenectomy in Non-mappers Undergoing Sentinel Lymph Node Sampling for the Treatment of Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometrial Cancer
Keywords: selective surgical staging
lymphadenectomy
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 625
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. This study will gather information to help determine the best way to evaluate lymph nodes during surgery for endometrial cancer.


Eligibility criteria: Inclusion Criteria:

* Surgical candidate for complete hysterectomy and bilateral salpingooophorectomy with pelvic and aortic lymphadenectomy
* Histologically or cytologically confirmed carcinoma of the endometrium confined to the uterine corpus
* No clinical evidence of extra-uterine disease on pre-operative evaluation. Preoperative evaluation to rule-out extra-uterine disease may include a CT scan, MRI or ultrasound. Note: preoperative imaging is not mandatory for study enrollment.
* 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.

Neoadjuvant chemotherapy for this endometrial cancer is not allowed.

* 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 Performance Status greater than 2 (Appendix II)
* Uterine sarcoma
* 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 should be excluded
* Known allergy to iodine or indocyanine 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. Women of child-bearing potential will be excluded if they have a positive serum/urine pregnancy test

Primary outcomes:
measure: Recurrence free survival
timeFrame: up to 5 years
Secondary outcomes:
measure: Concordance between selective surgical staging and final pathology Incidence
timeFrame: 5 years
measure: Progression-free survival
timeFrame: up to 5 years
measure: Disease-specific Survival
timeFrame: up to 5 years
measure: Overall patient survival rate
timeFrame: 5 years
Other outcomes:
measure: Location patterns of nodal involvement associated with staging procedures
timeFrame: 5 years
measure: Location patterns of nodal involvement associated with disease stage
timeFrame: 5 years
measure: Patterns of nodal involvement associated with histological characteristics
timeFrame: 5 years
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Rachel Miller, M.D.
role: PRINCIPAL_INVESTIGATOR
References: