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NCT04291612Recruiting

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

Memorial Sloan Kettering Cancer Center

Start Date

2/26/2020

Completion Date

2/26/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

OTHER

Physical exam

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Conditions

Endometrial CancerEndometrioid AdenocarcinomaEndometrial Cancer Stage I

Locations

Hartford Healthcare Cancer Institute @ Hartford Hospital

Hartford, Connecticut 06102

United States

Miami Cancer Institute Baptist Health South Florida

Miami, Florida 33143

United States

ADVENTHEALTH (Data collection only)

Orlando, Florida 32804

United States

Mayo Clinic (Data Collection and Data Analysis)

Rochester, Minnesota 55905

United States

Memorial Sloan Kettering Basking Ridge (All protocol activities)

Basking Ridge, New Jersey 07920

United States

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey 07748

United States

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey 07645

United States

Memorial Sloan Kettering Commack (All Protocol Activities)

Commack, New York 11725

United States

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Memorial Sloan Kettering Nassau (All protocol activities)

Rockville Centre, New York 11553

United States

Lehigh Valley Health Network

Allentown, Pennsylvania 18103

United States

Houston Methodist Cancer Center (Data Collection Only)

Houston, Texas 77030

United States

Charles University and General University Hospital (Data Collection Only)

Prague,

Czechia

OSPEDALE MICHELE E PIETRO (Data Collection Only)

Ferrera,

Italy

L'Azienda Sanitaria Universitaria Friuli Centrale

Udine,

Italy

OSLO UNIVERSITY HOSPITAL,RIKSHOPITALET (Data Collection Only)

Oslo,

Norway

Sulaiman Al Habib Medical Group

Khobar, Eastern Province

Saudi Arabia