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KMID : 1137020210320040060
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Journal of Gynecologic Oncology
2021 Volume.32 No. 4 p.60 ~ p.60
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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)
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Guan Jun
Xue Yu
Zang Rong-Yu
Liu Ji-Hong
Zhu Jian-Qing
Zheng Ying
Wang Bo
Wang Hua-Ying
Chen Xiao-Jun
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Abstract
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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.
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KEYWORD
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Sentinel Lymph Node, Lymphadenectomy, Endometrial Neoplasms, Uterus-Confined, Intermediate-High Risk, RCT
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