Ensayos clínicos

Inclusion Criteria - Preop:

• 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 pelvic +/- abdominal 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

Exclusion Criteria - Preop:

• Extrauterine disease, 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.

Inclusion Criteria - Postop:

• Hysterectomy.
• Bilateral salpingo-oophorectomy, unless already previously performed.
• Bilateral pelvic SLN mapping (bilateral sentinel nodes are negative for malignancy).
• Final pathology must show 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).
• Final pathology must show negative pelvic peritoneal cytology.
• Adjuvant treatment as recommended by the multidisciplinary team must be
  as follows:
  o No adjuvant treatment; or
  o Intravaginal radiation only.

Exclusion Criteria - Postop:

• 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.