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

Recruiting

• Conditions: Endometrioid Adenocarcinoma; Endometrial Cancer; Endometrial Cancer Stage I
• Interventions: Other: Physical exam

• Registration Number: NCT04291612
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-02-26
• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-03-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24
• Primary Completion: 2025-02-26
• Study Completion: 2025-02-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1400

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Part 2	Physical exam	Participants will have undergone surgery and bilateral sentinel lymph node mapping (negative for malignancy)

Primary Outcome Measures

Name	Time	Method
Incidence of pelvic/non-vaginal recurrence at 36 months	36 months	Participants will be assessed every 6 (+/- 2) months for 36 months through routine physical examination

Trial Locations

Locations (19)

Mayo Clinic (Data Collection and Data Analysis); 🇺🇸 Rochester, Minnesota, United States

University of Miami (Data Collection Only); 🇺🇸 Miami, Florida, United States

Miami Cancer Institute Baptist Health South Florida; 🇺🇸 Miami, Florida, United States

ADVENTHEALTH (Data collection only); 🇺🇸 Orlando, Florida, United States

Memorial Sloan Kettering Commack (All Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (All protocol activities); 🇺🇸 Rockville Centre, New York, United States

Charles University and General University Hospital (Data Collection Only); 🇨🇿 Prague, Czechia

Lehigh Valley Health Network; 🇺🇸 Allentown, Pennsylvania, United States

Memorial Sloan Kettering Basking Ridge (All protocol activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All protocol activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All protocol activities); 🇺🇸 Montvale, New Jersey, United States

OSLO UNIVERSITY HOSPITAL,RIKSHOPITALET (Data Collection Only); 🇳🇴 Oslo, Norway

Hartford Healthcare Cancer Institute @ Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

OSPEDALE MICHELE E PIETRO (Data Collection Only); 🇮🇹 Ferrera, Italy

UNIVERSITY OF MILANO-BICOCCA, ITALY (Data Collection); 🇮🇹 Milan, Italy

FONDAZIONE POLICLINICOUNIVERSITARIO A. GEMELLI, ITALY (Data Collection Only); 🇮🇹 Roma, Italy

L'Azienda Sanitaria Universitaria Friuli Centrale; 🇮🇹 Udine, Italy

Memorial Sloan Kettering Westchester (All protocol activities); 🇺🇸 Harrison, New York, United States