SEntinel Lymph Node Endometrial Cancer Trial: A Prospective Multicenter International Single-Arm Observational Trial (SELECT)

Memorial Sloan Kettering Cancer Center19 sites in 4 countries1,715 target enrollmentFebruary 26, 2020

ConditionsEndometrial Cancer Endometrioid Adenocarcinoma Endometrial Cancer Stage I

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Endometrial Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 1715
Locations: 19
Primary Endpoint: Incidence of pelvic/non-vaginal recurrence at 36 months
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is being done to find out how often endometrial cancer recurs after the standard treatment as well as how often the standard treatment results in a lymphedema.

Registry

clinicaltrials.gov

Start Date

February 26, 2020

End Date

February 26, 2026

Last Updated

5 months ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•ECOG performance status 0-1 or KPS ≥ 70%
•Age ≥ 18 years
•Endometrioid adenocarcinoma histologic diagnosis on endometrial biopsy or dilatation and curettage
•No evidence of extrauterine disease, or suspicious pelvic lymph nodes, or distant metastases, or cervical invasion on pre-operative conventional imaging studies (Pelvic +/- Abdomen CT or MRI or sonogram, or body PET scan) and physical examination (uterine confined by exam and imaging )
•Suitable candidate for surgery
•Planned surgical treatment including hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy
•No history of second primary cancer (invasive or in situ) within the past 5 years, not including non-melanoma skin cancer
•Approved and signed informed consent
•No history of neoadjuvant chemotherapy or radiotherapy for endometrial cancer
•No history of prior pelvic or abdominal radiotherapy

Exclusion Criteria

•Extrauterine disease, or gross lymph node involvement, or cervical invasion suspected on pre-operative imaging studies and physical examination (disease not uterine confined clinical stage \> I)
•Contraindication for SLN mapping
•The planned treatment is not surgery, or the surgical treatment does not include hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy
•Eligibility Inclusion Criteria
•Patients will be classified in the study cohort (part 2; n=182) according to surgical treatment received, final post hysterectomy and staging pathologic report, and planned adjuvant treatment. The inclusion criteria are specified below.
•Study Cohort (n=182)
•A patient will be enrolled in the study cohort if all the following criteria are met:
•At surgery, the patient must undergo:
•Hysterectomy
•Bilateral salpingo-oophorectomy, unless already performed (including allowing unilateral salpingo-oophorectomy if unilateral salpingo-oophorectomy already performed)