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

Study Overview
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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.

Official Title
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SEntinel Lymph Node Endometrial Cancer Trial: A Prospective Multicenter International Single-Arm Observational Trial (SELECT)

Conditions
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Endometrial Cancer, Endometrioid Adenocarcinoma, Endometrial Cancer Stage I

Intervention / Treatment
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* Other: Physical exam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Part 1<br>Participants will have endometrioid adenocarcinoma histological diagnosis with planned surgical treatment including hysterectomy in combination with SLN biopsy. | |
| Part 2<br>Participants will have undergone surgery and bilateral sentinel lymph node mapping (negative for malignancy) | Other: Physical exam<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pelvic/non-vaginal recurrence at 36 months | Participants will be assessed every 6 (+/- 2) months for 36 months through routine physical examination | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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20-067, Endometrial Cancer, Endometrioid Adenocarcinoma, Memorial Sloan Kettering Cancer Center