Overview

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

Part I Inclusion Criteria:

• ECOG performance status 0-1 or KPS 70%
• Age 18 years
• Endometrioid adenocarcinoma histologic diagnosis on endometrial biopsy or dilatation and curettage confirmed at the enrolling institution
• 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
• 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

Part 1 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

Part 2 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 (part 2 n=182)

A patient will be enrolled in the study cohort (part 2) if all the following criteria are

• At surgery, the patient must undergo:
• Hysterectomy with removal of the adnexa
• 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)
• Negative pelvic peritoneal cytology
• Adjuvant treatment as recommended by the multidisciplinary team must be as follows:
• No adjuvant treatment, or
• Intravaginal radiation only

Part 2 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
• 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