A Phase II Study of the Levonorgestrel Intrauterine Device (Mirena) to Treat Complex Atypical Hyperplasia and Grade 1 Endometrioid Endometrial Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 69
- 试验地点
- 14
- 主要终点
- Efficacy of the Levonorgestrel Intrauterine Device (IUD)
研究概览
简要总结
This phase II trial studies how well levonorgestrel-releasing intrauterine system works in treating patients with complex atypical hyperplasia or grade I endometrial cancer. High levels of estrogen can cause the growth of endometrial cancer cells. Progesterone can help balance the amount of estrogen present. Hormone therapy using levonorgestrel, a type of progesterone, may fight endometrial cancer by helping regulate hormone levels.
详细描述
PRIMARY OBJECTIVES:
I. To determine the efficacy of the levonorgestrel intrauterine device (IUD) (levonorgestrel-releasing intrauterine system) to treat complex atypical hyperplasia (CAH) and grade 1 endometrioid endometrial carcinoma (G1 EEC).
II. To determine if response to therapy can be predicted based on the molecular profile of the tumor or by change in gene expression after therapy.
SECONDARY OBJECTIVES:
I. To assess quality of life outcomes in patients treated with levonorgestrel IUD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients with a diagnosis of complex atypical hyperplasia or endometrial biopsy within three months of study enrollment OR patients with a diagnosis of grade 1 endometrioid endometrial carcinoma on endometrial biopsy within three months of study enrollment in the presence of one or more of the following: 1)desire for future fertility 2)morbid obesity (body mass index > 40) 3)multiple co-morbidities (ASA Class 3 or 4)
- •No prior treatment for diagnoses in inclusion criteria
- •Women of any racial or ethnic group.
- •Ability to comply with endometrial biopsies every 3 months.
- •Willing and able to sign informed consent.
- •Age greater than 18 years.
排除标准
- •Diagnosis of grade 1 endometrioid endometrial carcinoma without the presence of one of the 3 criteria mentioned in inclusion criteria
- •Diagnosis of grade 2 endometrioid endometrial carcinoma or higher on endometrial biopsy or on dilation and curettage specimen.
- •Evidence of extrauterine spread of disease on imaging or during surgical evaluation.
- •Congenital or acquired uterine anomaly which distorts the uterine cavity.
- •Acute pelvic inflammatory disease.
- •Acute liver disease or previously diagnosed liver tumor (benign or malignant).
- •Conditions associated with increased susceptibility to infections with microorganisms. Such conditions include, but are not limited to, AIDS, leukemia and IV drug abuse.
- •Genital actinomycosis.
- •Current carcinoma of the breast.
- •Current pregnancy.
- •Breastfeeding mothers.
结局指标
主要结局
Efficacy of the Levonorgestrel Intrauterine Device (IUD)
时间窗: At 1 year
To determine the efficacy of the Levonorgestrel Intrauterine Device (IUD) to treat complex atypical hyperplasia (CAH) and grade 1 endometrioid endometrial carcinoma (G1 EEC), defined as complete regression disease. The primary efficacy endpoint was pathologic response rate (RR) at 12 months defined as complete response (CR) or partial response (PR). CR was defined as no evidence of cancer or hyperplasia with atypia in patients with (CAH) or EEC. PR was defined as CAH in patients with EEC. Progressive disease (PD) was defined as grade 2 endometrioid endometrial cancer or above in patients with EEC or the presence of any cancer in patients with CAH.
Response Rate at 12 Month
时间窗: At 1 year
Will be defined as complete response or partial response based on the endometrial biopsy.
次要结局
- Quality of Life Score Using the Short Form-36 (SF-36) Survey(At baseline, 3 month, 6 month, 9 month and 12 month)