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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1715 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-26

Study Completion Date

2026-02-26

Brief Summary

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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.

Detailed Description

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Conditions

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Endometrial Cancer Endometrioid Adenocarcinoma Endometrial Cancer Stage I

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Part 1

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

No interventions assigned to this group

Part 2

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

Physical exam

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

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

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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nadeem Abu-Rustum, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

PMID: 32699021 (View on PubMed)

Other Identifiers

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20-067

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Part 1

Part 2

Physical exam

Interventions

Physical exam

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Memorial Sloan Kettering Cancer Center

Responsible Party

Principal Investigators

Nadeem Abu-Rustum, MD

Locations

Hartford Healthcare Cancer Institute @ Hartford Hospital

University of Miami (Data Collection Only)

Miami Cancer Institute Baptist Health South Florida

ADVENTHEALTH (Data collection only)

Mayo Clinic (Data Collection and Data Analysis)

Memorial Sloan Kettering Basking Ridge (All protocol activities)

Memorial Sloan Kettering Monmouth (All protocol activities)

Memorial Sloan Kettering Bergen (All protocol activities)

Memorial Sloan Kettering Commack (All Protocol Activities)

Memorial Sloan Kettering Westchester (All protocol activities)

Memorial Sloan Kettering Cancer Center

Memorial Sloan Kettering Nassau (All protocol activities)

Lehigh Valley Health Network

Charles University and General University Hospital (Data Collection Only)

OSPEDALE MICHELE E PIETRO (Data Collection Only)

UNIVERSITY OF MILANO-BICOCCA, ITALY (Data Collection)

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

L'Azienda Sanitaria Universitaria Friuli Centrale

OSLO UNIVERSITY HOSPITAL,RIKSHOPITALET (Data Collection Only)

Countries

Central Contacts

Nadeem Abu-Rustum, MD

Mario Leitao, MD

Facility Contacts

Jonathan Cosin, MD

Brian Clomovitz, MD

John Paul Diaz, MD

Robert Holloway, MD

Andrea Mariani, MD

Nadeem Abu-Rustum, MD

Nadeem Abu-Rustum, MD

Nadeem Abu-Rustum, MD

Nadeem Abu-Rustum, MD

Nadeem Abu-Rustum, MD

Nadeem Abu-Rustum, MD

Nadeem Abu-Rustum, MD

Martin Martino, MD

Alessandro Buda, MD

Tommaso Grassi, MD

Giovanni Scambia, MD

Giuseppe Vizzielli, MD

Ane Gerda, MD, PhD

References

Related Links

Other Identifiers

20-067