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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04291612
Recruitment Status : Recruiting
First Posted : March 2, 2020
Last Update Posted : May 9, 2023
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Endometrial Cancer Endometrioid Adenocarcinoma Endometrial Cancer Stage I Other: Physical exam

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Study Type : Observational
Estimated Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SEntinel Lymph Node Endometrial Cancer Trial: A Prospective Multicenter International Single-Arm Observational Trial (SELECT)
Actual Study Start Date : February 26, 2020
Estimated Primary Completion Date : February 26, 2024
Estimated Study Completion Date : February 26, 2024

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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)
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 :
  1. Incidence of pelvic/non-vaginal recurrence at 36 months [ Time Frame: 36 months ]
    Participants will be assessed every 6 (+/- 2) months for 36 months through routine physical examination

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or a member of the research teams. If the investigator is a member of the treatment team, s/he will screen their patients' medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study. The principal investigators may also screen the medical records of patients with whom they do not have a treatment relationship for the limited purpose of identifying patients who would be eligible to enroll in the study, and to record appropriate contact information in order to approach these patients regarding the possibility of enrolling in the study. Patients identified in this manner would subsequently be approached for study enrollment after consultation with their treating physician.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04291612

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Contact: Nadeem Abu-Rustum, MD 212-639-7051 abu-rusn@mskcc.org
Contact: Mario Leitao, MD 212-639-3987 leitaom@mskcc.org

Show Show 20 study locations
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
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Principal Investigator: Nadeem Abu-Rustum, MD Memorial Sloan Kettering Cancer Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04291612    
Other Study ID Numbers: 20-067
First Posted: March 2, 2020    Key Record Dates
Last Update Posted: May 9, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Endometrial Cancer
Endometrioid Adenocarcinoma
Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:
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Endometrial Neoplasms
Carcinoma, Endometrioid
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Ovarian Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases