Actively Recruiting

Age: 18Years +
FEMALE
NCT04291612

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

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-01

1715

Participants Needed

19

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • ECOG performance status 0-1 or Karnofsky Performance Status  70%
  • Age 18 years or older
  • Histologic diagnosis of endometrioid adenocarcinoma on endometrial biopsy or dilatation and curettage
  • No signs of extrauterine disease, suspicious pelvic lymph nodes, distant metastases, or cervical invasion on pre-operative imaging and physical exam
  • Suitable candidate for surgery
  • Planned surgery including hysterectomy, sentinel lymph node biopsy, and bilateral salpingo-oophorectomy
  • No history of second primary cancer (invasive or in situ) within past 5 years except non-melanoma skin cancer
  • Signed informed consent
  • No prior neoadjuvant chemotherapy or radiotherapy for endometrial cancer
  • No prior pelvic or abdominal radiotherapy
  • Undergo hysterectomy and bilateral salpingo-oophorectomy (unless unilateral already done)
  • Bilateral pelvic sentinel lymph node mapping with negative nodes
  • Diagnosed with stage I intermediate-risk endometrioid cancer as defined
  • Negative pelvic peritoneal cytology
  • Adjuvant treatment limited to none or intravaginal radiation only
Not Eligible

You will not qualify if you...

  • Evidence of extrauterine disease, gross lymph node involvement, or cervical invasion on pre-operative imaging or exam
  • Contraindication to sentinel lymph node mapping
  • Planned treatment not including surgery or surgery not including hysterectomy with sentinel lymph node biopsy and bilateral salpingo-oophorectomy
  • Intra-operative detection of extra-uterine disease or grossly involved lymph nodes
  • Any positive pelvic lymph nodes including micrometastasis or isolated tumor cells
  • Hysterectomy not performed
  • Bilateral salpingo-oophorectomy not performed unless previously done unilaterally
  • Failed unilateral or bilateral sentinel lymph node mapping
  • Undergoing complete unilateral or bilateral pelvic lymphadenectomy
  • Undergoing radical type C hysterectomy
  • Stage IA endometrioid cancer grade 1 or 2 with less than 50% myometrial invasion
  • Stage IB grade 3 endometrioid cancer
  • Non-endometrioid histology including serous, clear cell, carcinosarcoma, undifferentiated, or de-differentiated histology
  • Empty sentinel lymph node packets
  • Positive peritoneal cytology

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 19 locations

1

Hartford Healthcare Cancer Institute @ Hartford Hospital

Hartford, Connecticut, United States, 06102

Actively Recruiting

2

University of Miami (Data Collection Only)

Miami, Florida, United States, 33136

Not Yet Recruiting

3

Miami Cancer Institute Baptist Health South Florida

Miami, Florida, United States, 33143

Actively Recruiting

4

ADVENTHEALTH (Data collection only)

Orlando, Florida, United States, 32804

Actively Recruiting

5

Mayo Clinic (Data Collection and Data Analysis)

Rochester, Minnesota, United States, 55905

Active, Not Recruiting

6

Memorial Sloan Kettering Basking Ridge (All protocol activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

7

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

8

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

9

Memorial Sloan Kettering Commack (All Protocol Activities)

Commack, New York, United States, 11725

Actively Recruiting

10

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, United States, 10604

Actively Recruiting

11

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

12

Memorial Sloan Kettering Nassau (All protocol activities)

Rockville Centre, New York, United States, 11553

Actively Recruiting

13

Lehigh Valley Health Network

Allentown, Pennsylvania, United States, 18103

Actively Recruiting

14

Charles University and General University Hospital (Data Collection Only)

Prague, Czechia

Terminated

15

OSPEDALE MICHELE E PIETRO (Data Collection Only)

Ferrera, Italy

Actively Recruiting

16

UNIVERSITY OF MILANO-BICOCCA, ITALY (Data Collection)

Milan, Italy

Not Yet Recruiting

17

FONDAZIONE POLICLINICOUNIVERSITARIO A. GEMELLI, ITALY (Data Collection Only)

Roma, Italy

Not Yet Recruiting

18

L'Azienda Sanitaria Universitaria Friuli Centrale

Udine, Italy

Actively Recruiting

19

OSLO UNIVERSITY HOSPITAL,RIKSHOPITALET (Data Collection Only)

Oslo, Norway

Not Yet Recruiting

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Research Team

N

Nadeem Abu-Rustum, MD

CONTACT

M

Mario Leitao, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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