J Gynecol Oncol.  2021 Jul;32(4):e60. 10.3802/jgo.2021.32.e60.

Sentinel lymph Node mapping versus systematic pelvic lymphadenectomy on the prognosis for patients with intermediate-high-risk Endometrial Cancer confined to the uterus before surgery: trial protocol for a non-inferiority randomized controlled trial (SNEC trial)

Affiliations
  • 1Department of Gynecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China
  • 2Shanghai Key Laboratory of Female Reproductive Endocrine Related Diseases, Shanghai, China
  • 3Shanghai Medical college, Fudan University, Shanghai, China
  • 4Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China
  • 5Department of Gynecology Oncology, Cancer Center, Sun Yat-sen University, Guangzhou, China
  • 6Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China
  • 7Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu, China
  • 8Department of Gynecology, Fudan University Shanghai Cancer Center, Shanghai, China

Abstract

Background
Sentinel lymph node (SLN) mapping has been recommended as an alternative staging approach to lymphadenectomy for apparent uterine-confined endometrial cancer (EC). However, the prognostic value of SLN mapping alone instead of systematic lymphadenectomy on EC patients remains unclear.
Methods
A multi-center, open label, non-inferiority randomized controlled trial has been designed to identify if SLN mapping alone is not inferior to pelvic lymphadenectomy on prognosis of patients with intermediate-high-risk EC clinically confined to uterus. Eligible patients will be 1:1 randomly assigned to accept SLN mapping or pelvic lymphadenectomy. The primary endpoint is the 2-year progression-free survival (PFS). The second points are the 5-year PFS, 5-year overall survival, surgery-related adverse events and life quality. A total of 780 patients will be enrolled from 6 hospitals in China within 3-year period and followed up for 5 years.

Keyword

Sentinel Lymph Node; Lymphadenectomy; Endometrial Neoplasms; Uterus-Confined; Intermediate-High Risk; RCT
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