Effect of Fertility-sparing Therapy of Early Endometrial Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
The purpose of this study is to investigate the effect of Fertility-sparing Therapy of Early Endometrial Cancer.
详细描述
This is a prospective, multi center, open, randomized, controlled clinical trial. All endometrial cancer (EC) or atypical hyperplasia (AH) patients who met the fertility-sparing indications in the hospitals involved in this study were recruited. Then the investigators conducted assessment, treatment and follow up according to the standard procedure. General information, therapeutic regimen, side effects, oncological and pregnant results were collected for risk factors analysis.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ages of no more than 40
- •with a strong desire of fertility preservation
- •International Federation of Gynecology and Obstetrics (FIGO) 2009 stage Ⅰa grade 1~2 with lesion confined in endometrium
- •pathology expression of progestin receptors (PRs) and estrogen receptors
排除标准
- •not eligible for pregnancy or delivery
- •evidence of suspected extrauterine or distant metastasis
- •complicated with any other malignancy
- •severe medical complications
- •contraindication of oral progestin
- •uncontrolled epilepsy, central nervous system disease or mental disorder history in patients which Influence clinical research compliance judging by the researcher.
研究组 & 干预措施
BMI≥25 group with metformin
Patients with BMI≥25kg/m2 in the experimental group are treated with medroxyprogesterone acetate (MPA) 0.25g/d plus metformin and are followed-up of baseline data, hormone levels,
干预措施: Metformin (Drug)
结局指标
主要结局
Complete response rate
时间窗: through study completion, an average of 3 months
Histologically shows absence of pathological hyperplasia or carcinoma.
次要结局
- Pregnancy rate(through study completion, an average of 3 months)