Recruiting

Observational Study

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT04291612

Conditions

Endometrial Cancer

Endometrioid Adenocarcinoma

Endometrial Cancer Stage I

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Physical exam

Study Details

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.

Conditions

Endometrial Cancer

Endometrioid Adenocarcinoma

Endometrial Cancer Stage I

Study ID

NCT04291612

Start date

Feb 26, 2020

Status verified date

Aug, 2026

Completion date

Feb 26, 2027

Anticipated

Primary completion date

Feb 26, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

1715 participants

Anticipated

Interventions and Outcome Measures

Arms

Part 1

Participants will have endometrioid adenocarcinoma histological diagnosis with planned surgical treatment including hysterectomy in combination with SLN biopsy.

Part 2

Participants will have undergone surgery and bilateral sentinel lymph node mapping (negative for malignancy)

Interventions

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 measure

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

Central Contacts and Locations

Central contacts

Nadeem Abu-Rustum, MD

212-639-7051abu-rusn@mskcc.org

Mario Leitao, MD

212-639-3987leitaom@mskcc.org

Locations

Hartford Healthcare Cancer Institute @ Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Jonathan Cosin, MD

860-826-1101

Miami Cancer Institute Baptist Health South Florida

Recruiting

Miami, Florida, United States, 33143

Contacts

John Paul Diaz, MD

786-596-2000

ADVENTHEALTH (Data collection only)

Recruiting

Orlando, Florida, United States, 32804

Contacts

Robert Holloway, MD

407-303-2422

Memorial Sloan Kettering Basking Ridge (All protocol activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Nadeem Abu-Rustum, MD

212-639-7051

Memorial Sloan Kettering Monmouth (All protocol activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Nadeem Abu-Rustum, MD

212-639-7051

Memorial Sloan Kettering Bergen (All protocol activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Nadeem Abu-Rustum, MD

212-639-7051

Memorial Sloan Kettering Commack (All Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Nadeem Abu-Rustum, MD

212-639-7051

Memorial Sloan Kettering Westchester (All protocol activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Nadeem Abu-Rustum, MD

212-639-7051

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Nadeem Abu-Rustum, MD

212-639-7051

Memorial Sloan Kettering Nassau (All protocol activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Nadeem Abu-Rustum, MD

212-639-7051

Lehigh Valley Health Network

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Martin Martino, MD

610-402-3650

Houston Methodist Cancer Center (Data Collection Only)

Recruiting

Houston, Texas, United States, 77030

Contacts

Pedro Ramirez, md

713-441-1026

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • Endometrial Cancer
  • Endometrioid Adenocarcinoma
  • 20-067
  • Memorial Sloan Kettering Cancer Center

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-08-07.