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Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease
NCT04291612 · Memorial Sloan Kettering Cancer Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
SEntinel Lymph Node Endometrial Cancer Trial: A Prospective Multicenter International Single-Arm Observational Trial (SELECT)
About this study
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.
Eligibility criteria
Screening 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
Screening 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)
* Bilateral pelvic SLN mapping (bilateral sentinel nodes are negative for malignancy)
* On the final pathologic report, the patient must have a diagnosis of:
* Stage I intermediate-risk endometrial endometrioid cancer (Grade 1 or Grade 2 with ≥ 50% myometrial invasion or Grade 3 with \<50% myometrial invasion, including non-invasive disease)
* Negative pelvic peritoneal cytology
* Adjuvant treatment as recommended by the multidisciplinary team must be as follows:
* No adjuvant treatment, or
* Intravaginal radiation only
Eligibility Exclusion Criteria
* There is intra-operative detection of extra-uterine disease or grossly involved lymph nodes
* Presence of any positive pelvic nodes including micrometastasis and isolated tumor cells (ITC)
* Hysterectomy is not performed
* Bilateral salpingo-oophorectomy is not performed, unless already performed (unilateral salpingo-oophorectomy is allowed if unilateral salpingo-oophorectomy already performed)
* Failed unilateral or bilateral SLN mapping
* Patient undergoes a complete unilateral or bilateral pelvic lymphadenectomy
* Patient undergoes a radical type C hysterectomy
* Stage IA endometrioid cancer Grade1 or 2 and myometrial invasion \<50%
* Stage IB Grade 3 endometrioid cancer
* Non-endometrioid histology: Serous, clear cell, carcinosarcoma, undifferentiated, or de-differentiated histology noted on final hysterectomy pathology
* Empty unilateral or bilateral sentinel lymph nodal packet(s)
* Positive peritoneal cytology
Study design
Enrollment target: 1715 participants
Age groups: adult, older_adult
Timeline
Starts: 2020-02-26
Estimated completion: 2027-02-26
Last updated: 2026-04-01
Interventions
Other: Physical exam
Primary outcomes
- • Incidence of pelvic/non-vaginal recurrence at 36 months (36 months)
Sponsor
Memorial Sloan Kettering Cancer Center · other
Contacts & investigators
ContactNadeem Abu-Rustum, MD · contact · abu-rusn@mskcc.org · 212-639-7051
ContactMario Leitao, MD · contact · leitaom@mskcc.org · 212-639-3987
InvestigatorNadeem Abu-Rustum, MD · principal_investigator, Memorial Sloan Kettering Cancer Center
All locations (19)
Hartford Healthcare Cancer Institute @ Hartford HospitalRecruiting
Hartford, Connecticut, United States
University of Miami (Data Collection Only)Not Yet Recruiting
Miami, Florida, United States
Miami Cancer Institute Baptist Health South FloridaRecruiting
Miami, Florida, United States
ADVENTHEALTH (Data collection only)Recruiting
Orlando, Florida, United States
Mayo Clinic (Data Collection and Data Analysis)Active Not Recruiting
Rochester, Minnesota, United States
Memorial Sloan Kettering Basking Ridge (All protocol activities)Recruiting
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All protocol activities)Recruiting
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All protocol activities)Recruiting
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (All Protocol Activities)Recruiting
Commack, New York, United States
Memorial Sloan Kettering Westchester (All protocol activities)Recruiting
Harrison, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Memorial Sloan Kettering Nassau (All protocol activities)Recruiting
Rockville Centre, New York, United States
Lehigh Valley Health NetworkRecruiting
Allentown, Pennsylvania, United States
Charles University and General University Hospital (Data Collection Only)Terminated
Prague, Czechia
OSPEDALE MICHELE E PIETRO (Data Collection Only)Recruiting
Ferrera, Italy
UNIVERSITY OF MILANO-BICOCCA, ITALY (Data Collection)Not Yet Recruiting
Milan, Italy
FONDAZIONE POLICLINICOUNIVERSITARIO A. GEMELLI, ITALY (Data Collection Only)Not Yet Recruiting
Roma, Italy
L'Azienda Sanitaria Universitaria Friuli CentraleRecruiting
Udine, Italy
OSLO UNIVERSITY HOSPITAL,RIKSHOPITALET (Data Collection Only)Not Yet Recruiting
Oslo, Norway