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.
• 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
∙ 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 previously 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