The Therapeutic Effect of Medroxyprogesterone Acetate vs. LNG-IUS in Early-stage Endometrioid Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
In modern society, endometrial cancer (EC) and atypical hyperplasia is the most frequent desease which can affect the fertility of young patients. For young patients, there is a growing need to treat tumors and fertility sparing. Advaced studies have confirmed thatfertility preservation therapy has better tumor and pregnancy outcomes in specific patients with early gynecological tumors. Clinically, evidence-based guidelines are urgently needed to guide the screening and treatment of women who are suitable for fertility preservation. Fertility-sparing treatment predominantly involves the use of oral progestins and levonorgestrel-releasing intrauterine devices, which have been shown to be feasible and safe in women with early stage EC and minimal or no myometrial invasion. However, data on the efficacy and safety of conservative management strategies are primarily based on retrospective studies.The present study aims to compared the therapeutic effect of Medroxyprogesterone acetate (MPA) and Levonorgestrel-releasing intrauterine system (LNG-IUS) in early-stage endometrioid carcinoma and atypical hyperplasia patients
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
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≤ 45 years old;
- •Diagnostic curettage pathology is highly differentiated endometrioid adenocarcinoma;
- •pelvic augmentation MRI or / and vaginal color ultrasound Doppler examination, tumor confined endometrium;
- •No suspicious metastatic lesions;
- •Endometrial pathological tissue specimens with strong positive expression of estrogen and progesterone receptors;
- •Blood CA125 is normal;
- •no progesterone therapy and contraindications to pregnancy;
- •The patient himself has a strong desire to preserve fertility, and the patient should fully understand that fertility preservation treatment is not the standard treatment method;
- •Conditional acceptance of close follow-up.
排除标准
- •type II endometrial cancer;
- •Patients with abnormal liver and kidney function and other contraindications to progesterone therapy;
- •Other parts of the body are concurrent or successively complicated by other malignant tumors;
- •The patient and his/her family are unable to sign the informed consent form for any reason;
- •Unconditional follow-up.
研究组 & 干预措施
Medroxyprogesterone acetate
Administered MPA at a dosage of 500 mg/d concurrently
干预措施: Medroxyprogesterone Acetate 500 MG Oral Tablet (Drug)
LNG-IUS
Go through LNG-IUS insertion
干预措施: Levonorgestrel-Releasing Intrauterine System (Device)
结局指标
主要结局
Complete response rate
时间窗: 24-week
The 24-week CR rate will be calculated in two groups.
次要结局
- The pregnancy rate(Up to 2 years after the treatment)
- The live-birth rate(Up to 2 years after the treatment)
- Time to achieve complete response(From date of randomization until the date of CR, assessed up to 24 weeks)
研究者
Hua Li
Department of Obstetrics and Gynecology
Beijing Chao Yang Hospital