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

Description

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 Overview

Study Details

Study 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.

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

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

Condition
Endometrial Cancer
Intervention / Treatment

-

Contacts and Locations

Hartford

Hartford Healthcare Cancer Institute @ Hartford Hospital, Hartford, Connecticut, United States, 06102

Miami

University of Miami (Data Collection Only), Miami, Florida, United States, 33136

Miami

Miami Cancer Institute Baptist Health South Florida, Miami, Florida, United States, 33143

Orlando

ADVENTHEALTH (Data collection only), Orlando, Florida, United States, 32804

Rochester

Mayo Clinic (Data Collection and Data Analysis), Rochester, Minnesota, United States, 55905

Basking Ridge

Memorial Sloan Kettering Basking Ridge (All protocol activities), Basking Ridge, New Jersey, United States, 07920

Middletown

Memorial Sloan Kettering Monmouth (All protocol activities), Middletown, New Jersey, United States, 07748

Montvale

Memorial Sloan Kettering Bergen (All protocol activities), Montvale, New Jersey, United States, 07645

Commack

Memorial Sloan Kettering Commack (All Protocol Activities), Commack, New York, United States, 11725

Harrison

Memorial Sloan Kettering Westchester (All protocol activities), Harrison, New York, United States, 10604

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Nadeem Abu-Rustum, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2025-02-26