Clinical trial NCT04291612: Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease
Official title: SEntinel Lymph Node Endometrial Cancer Trial: A Prospective Multicenter International Single-Arm Observational Trial (SELECT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Cancer
Endometrioid Adenocarcinoma
Endometrial Cancer Stage I
Keywords: Endometrial Cancer
Endometrioid Adenocarcinoma
20-067
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 1400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or a member of the research teams. If the investigator is a member of the treatment team, s/he will screen their patients' medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study. The principal investigators may also screen the medical records of patients with whom they do not have a treatment relationship for the limited purpose of identifying patients who would be eligible to enroll in the study, and to record appropriate contact information in order to approach these patients regarding the possibility of enrolling in the study. Patients identified in this manner would subsequently be approached for study enrollment after consultation with their treating physician.

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.


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 previously 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 previously 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

Primary outcomes:
measure: Incidence of pelvic/non-vaginal recurrence at 36 months
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Healthcare Cancer Institute @ Hartford Hospital
state: Connecticut
city: Miami
country: United States
facility: University of Miami (Data Collection Only)
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute Baptist Health South Florida
state: Florida
city: Orlando
country: United States
facility: ADVENTHEALTH (Data collection only)
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic (Data Collection and Data Analysis)
state: Minnesota
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All protocol activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All protocol activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (All Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All protocol activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (All protocol activities)
state: New York
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Prague
country: Czechia
facility: Charles University and General University Hospital (Data Collection Only)
city: Ferrera
country: Italy
facility: OSPEDALE MICHELE E PIETRO (Data Collection Only)
city: Milan
country: Italy
facility: UNIVERSITY OF MILANO-BICOCCA, ITALY (Data Collection)
city: Roma
country: Italy
facility: FONDAZIONE POLICLINICOUNIVERSITARIO A. GEMELLI, ITALY (Data Collection Only)
city: Udine
country: Italy
facility: L'Azienda Sanitaria Universitaria Friuli Centrale
city: Oslo
country: Norway
facility: OSLO UNIVERSITY HOSPITAL,RIKSHOPITALET (Data Collection Only)
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nadeem Abu-Rustum, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grassi T, Mariani A, Cibula D, Soliman PT, Suman VJ, Weaver AL, Pedra Nobre S, Weigelt B, Glaser GE, Cappuccio S, Abu-Rustum NR. A prospective multicenter international single-arm observational study on the oncological safety of the sentinel lymph node algorithm in stage I intermediate-risk endometrial cancer (SELECT, SEntinel Lymph node Endometrial Cancer Trial). Int J Gynecol Cancer. 2020 Oct;30(10):1627-1632. doi: 10.1136/ijgc-2020-001698. Epub 2020 Jul 22.