Description
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
Inclusion Criteria
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 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 met:
- 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
Exclusion Criteria
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 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