The Randomized Multicentic Prospective Controlled Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Total survival Time
研究概览
简要总结
Through multicenter, prospective, randomized, controlled clinical studies comparing different treatment options (fertility-sparing surgery and ovarian preservation surgery and radical surgery)therapeutic efficacy, safety and quality of life of patients, exploration of the best strategies and risks for the treatment of early endometrial cancer, and promotion and application.
详细描述
Patients eligible for enrollment are selected and divided into three groups randomly, including fertility group,ovarian preservation group and endometrial cancer radical surgery group. Take interventions including fertility preservation surgery,ovarian preservation surgery and endometrial cancer radical surgery for patients in different groups respectively. Compare therapeutic efficacy, safety and quality of life of patients to evaluate three treatment and explore the best treatment for clinical application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women, age ≤ 50 years
- •Surgical curettage / hysteroscopic pathology confirmed, endometrioid adenocarcinoma G1/G2 (including well-differentiated, high-medium and middle-differentiation);
- •Clinical consideration of IA (<1/2 muscle infiltration);
- •First-time treatment
- •The subject (or his legal representative) must understand the nature of the study and sign an informed consent form.
排除标准
- •At the same time participate in other clinical trials;
- •Can not tolerate surgery;
- •Ovarian suspicious metastasis;
- •Have a family history of ovarian cancer;
- •Incorporate other malignant tumors;
- •Preoperative CA125 abnormal persons
研究组 & 干预措施
radical surgery group
Endometrial cancer radical surgery to be administered in this arm.
干预措施: endometrial cancer radical surgery (Procedure)
fertility preservation group
Fertility-sparing surgery to be administered in this arm.
干预措施: fertility-sparing surgery (Procedure)
ovarian preservation group
Ovarian preservation surgery to be administered in this arm.
干预措施: ovarian preservation surgery (Procedure)
结局指标
主要结局
Total survival Time
时间窗: 6 months
calculate the time from patients enter the group to death
次要结局
- the change of Ovarian volume(6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
- the change of endocrine function evaluation(6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
- Progression Free Survival(6 months)
研究者
Min Wang
Director
Shengjing Hospital