Status:
RECRUITING
Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Endometrial Cancer
Endometrioid Adenocarcinoma
Eligibility:
FEMALE
18+ years
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.
Eligibility Criteria
Inclusion
- Screening
- 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
- 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
Key Trial Info
Start Date :
February 26 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 26 2026
Estimated Enrollment :
1715 Patients enrolled
Trial Details
Trial ID
NCT04291612
Start Date
February 26 2020
End Date
February 26 2026
Last Update
November 10 2025
Active Locations (19)
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1
Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, United States, 06102
2
University of Miami (Data Collection Only)
Miami, Florida, United States, 33136
3
Miami Cancer Institute Baptist Health South Florida
Miami, Florida, United States, 33143
4
ADVENTHEALTH (Data collection only)
Orlando, Florida, United States, 32804