Clinical Trial: Endometrial Cancer, Cancer

MSK 20-067 Endometrial Cancer

Full Name

SEntinel Lymph node Endometrial Cancer Trial: A Prospective Multicenter International Single-Arm Observational Trial(SELECT)


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.


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