Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04291612
• Other study ID #: 20-067
• Status: Recruiting
• Start date: February 26, 2020
• Est. completion date: February 26, 2025

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Nadeem Abu-Rustum, MD
• Phone: 212-639-7051
• Email: abu-rusn[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: February 26, 2025
• Est. primary completion date: February 26, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Endometrioid
• Endometrial Cancer
• Endometrial Cancer Stage I
• Endometrial Neoplasms
• Endometrioid Adenocarcinoma

Intervention

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.

Locations

Country	Name	City	State
Czechia	Charles University and General University Hospital (Data Collection Only)	Prague
Italy	OSPEDALE MICHELE E PIETRO (Data Collection Only)	Ferrera
Italy	UNIVERSITY OF MILANO-BICOCCA, ITALY (Data Collection)	Milan
Italy	FONDAZIONE POLICLINICOUNIVERSITARIO A. GEMELLI, ITALY (Data Collection Only)	Roma
Italy	L'Azienda Sanitaria Universitaria Friuli Centrale	Udine
Norway	OSLO UNIVERSITY HOSPITAL,RIKSHOPITALET (Data Collection Only)	Oslo
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	Memorial Sloan Kettering Basking Ridge (All protocol activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack (All Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (All protocol activities)	Harrison	New York
United States	Hartford Healthcare Cancer Institute @ Hartford Hospital	Hartford	Connecticut
United States	Miami Cancer Institute Baptist Health South Florida	Miami	Florida
United States	University of Miami (Data Collection Only)	Miami	Florida
United States	Memorial Sloan Kettering Monmouth (All protocol activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (All protocol activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	ADVENTHEALTH (Data collection only)	Orlando	Florida
United States	Mayo Clinic (Data Collection and Data Analysis)	Rochester	Minnesota
United States	Memorial Sloan Kettering Nassau (All protocol activities)	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Countries where clinical trial is conducted

United States,  Czechia,  Italy,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pelvic/non-vaginal recurrence at 36 months	Participants will be assessed every 6 (+/- 2) months for 36 months through routine physical examination	36 months

External Links

•   Memorial Sloan Kettering Cancer Center