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

Egyéb feltételek

• 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 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