Dysautonomia International

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

Purpose

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.

Conditions

Endometrial Cancer
Endometrioid Adenocarcinoma
Endometrial Cancer Stage I

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: Female
Accepts Healthy Volunteers: No

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

Study Design

Phase
Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective

Arm Groups

Arm	Description	Assigned Intervention
Part 1	Participants will have endometrioid adenocarcinoma histological diagnosis with planned surgical treatment including hysterectomy in combination with SLN biopsy.
Part 2	Participants will have undergone surgery and bilateral sentinel lymph node mapping (negative for malignancy)	Other: 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.

Recruiting Locations

Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut 06102

Contact:
Jonathan Cosin, MD
860-826-1101

Miami Cancer Institute Baptist Health South Florida
Miami, Florida 33143

Contact:
John Paul Diaz, MD
786-596-2000

ADVENTHEALTH (Data collection only)
Orlando, Florida 32804

Contact:
Robert Holloway, MD
407-303-2422

Memorial Sloan Kettering Basking Ridge (All protocol activities)
Basking Ridge, New Jersey 07920