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
- KMID: 2526124
- DOI: http://doi.org/10.3802/jgo.2021.32.e60
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.
- Full Text Links
-
- Actions
-
Cited
- CITED
-
- Close
- Share
-
- Similar articles
-
- Randomized comparison between sentinel lymph node mapping using indocyanine green plus a fluorescent camera versus lymph node dissection in clinical stage I-II endometrial cancer: a Korean Gynecologic Oncology Group trial (KGOG2029/SELYE)
- A critical assessment on the role of sentinel node mapping in endometrial cancer
- Surgical technique of two-step pelvic and para-aortic sentinel lymph node mapping in early-stage endometrial cancer: laparoscopic, robotic, and open method
- Current landscape and future perspective of sentinel node mapping in endometrial cancer
- The role of lymphadenectomy in surgical staging of endometrial cancer
