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)

Overview

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.

Interventions

• Other Physical exam
  Part 2 participants will be prospectively followed clinically for relapse for 30 months from the date of surgery for physical examination at post-ops visits.

Primary outcome measures

• Incidence of pelvic/non-vaginal recurrence at 36 months [Time frame: 36 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 13 centers

• Hartford Healthcare Cancer Institute @ Hartford Hospital — Hartford
• Miami Cancer Institute Baptist Health South Florida — Miami
• ADVENTHEALTH (Data collection only) — Orlando
• Mayo Clinic (Data Collection and Data Analysis) — Rochester
• Memorial Sloan Kettering Basking Ridge (All protocol activities) — Basking Ridge
• Memorial Sloan Kettering Monmouth (All protocol activities) — Middletown
• Memorial Sloan Kettering Bergen (All protocol activities) — Montvale
• Memorial Sloan Kettering Commack (All Protocol Activities) — Commack
• … and 5 more centers

Italy · 2 centers

• OSPEDALE MICHELE E PIETRO (Data Collection Only) — Ferrera
• L'Azienda Sanitaria Universitaria Friuli Centrale — Udine

Czechia · 1 center

• Charles University and General University Hospital (Data Collection Only) — Prague

Norway · 1 center

• OSLO UNIVERSITY HOSPITAL,RIKSHOPITALET (Data Collection Only) — Oslo

Saudi Arabia · 1 center

• Sulaiman Al Habib Medical Group — Khobar

Publications

• 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 PMID 32699021

Identifiers

NCT: NCT04291612 · 20-067

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗