NCT04792749招募中3 期
Clinical Effects of Metformin on Fertility-sparing Treatment for Early Endometrial Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Treatment response rates
研究概览
简要总结
The purpose of the study is to investigate the effects of metformin in addition to the conventional progestin therapy in the fertility-sparing treatment of early stage endometrial cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Endometrial cancer radiologic International Federation of Obstetrics and Gynecology (FIGO) stage IA patients
- •Endometrioid endometrial cancer patients
- •FIGO cellular differentiation grade 1 patients
- •Patients who wish to preserve fertility
- •Patients who understand that the recommended treatment of endometrial cancer is surgical treatment even in early stages, but still wish to preserve fertility and avoid surgical treatment
- •Patients who have good performance status (Eastern Cooperation Oncology Group (ECOG) performance score equal to or greater than 3)
- •Patients who are not contraindicated to the progestin therapy
- •Patients who are not contraindicated to the use of metformin
排除标准
- •Patients who have already received chemotherapeutic or radiotherapeutic treatments for endometrial cancer
- •Patients whose disease is already advanced and not indicated for fertility-sparing treatment
- •Patients whose tumor cellular differentiation grade is greater than FIGO grade 1
研究组 & 干预措施
Metformin treatment
Experimental
Patients who receive metformin in addition to progestin therapy
干预措施: Metformin (Drug)
结局指标
主要结局
Treatment response rates
时间窗: 12 months after the initiation of the treatment
Measurements of the primary lesion by the RECIST criteria
次要结局
未报告次要终点
研究者
Jeong-Won Lee
Professor
Samsung Medical Center
研究点 (1)
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