The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma: A Multicenter, Prospective, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
This randomized trial is studying the efficacy and safety of the hysterectomy alone compared with hysterectomy and bilateral salpingo-oophorectomy (BSO) for patients with Stage IA endometrial carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •FIGO stage: ⅠA, endometrial carcinoma;
- •Female, Chinese women;
- •premenopausal women；
- •≤ 50 years old;
- •Pathological diagnosis by curettage/hysteroscopy : G1
- •No prior treatment;
- •Provide written informed consent.
排除标准
- •The suspicious metastasis of ovarian;
- •Family history of ovarian cancer;
- •Suffering from other malignancies;
- •Concurrently participating in other clinical trials;
- •Unable or unwilling to sign informed consents;
- •Unable or unwilling to abide by protocol.
研究组 & 干预措施
Total Hysterectomy (TH)
Patients may receive total hysterectomy (TH) and bilateral pelvic and para-aortic lymph node dissection (BPLND).
干预措施: TH (Procedure)
Total Hysterectomy (TH)
Patients may receive total hysterectomy (TH) and bilateral pelvic and para-aortic lymph node dissection (BPLND).
干预措施: BPLND (Procedure)
TH and bilateral salpingo-oophorectomy (TH/BSO)
Patients may receive total hysterectomy, bilateral salpingo-oophorectomy (BSO) and bilateral pelvic and para-aortic lymph node dissection.
干预措施: TH/BSO (Procedure)
TH and bilateral salpingo-oophorectomy (TH/BSO)
Patients may receive total hysterectomy, bilateral salpingo-oophorectomy (BSO) and bilateral pelvic and para-aortic lymph node dissection.
干预措施: BPLND (Procedure)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: 3-year DFS
次要结局
- Quality of Life(3-year period)
- Clinical gynecologic endocrine function(1-year period)
- Overall Survival (OS)(3-year OS)
研究者
Ding Ma
Director of the department of Obstetrics and Gynecology, Tongji Hospital
Huazhong University of Science and Technology