Treatment With Medroxyprogesterone Acetate(MPA) Plus Levonorgestrel-releasing Intrauterine System(LNG-IUS) in Young Women With Early Stage Endometrial Cancer: Multicenter Study: Korean Gynecologic Oncology Group Study (KGOG2009)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
A prospective multicenter trial has been started in Korea to investigate the treatment efficacy of Levonorgestrel-releasing intrauterine system (LNG-IUS) plus Medroxyprogesterone Acetate(MPA) in Young Women with Early Stage Endometrial Cancer.
The standard treatment for endometrial cancer is total hysterectomy and bilateral salpingo-oophorectomy, peritoneal cytology, and lymph node dissection. However, young patients who desire to preserve their potential for fertility may find this standard treatment difficult to accept. Therefore, the conservative treatment for these patients has remained a challenge. A number of studies have reported the effectiveness of hormonal therapy using systemic progestin in women clinically diagnosed with early endometrial adenocarcinoma at stage IA, grade 1, who want to maintain reproductive potential. In addition, several recent studies reported the use of LNG-IUS to treat patients at a high risk of perioperative complications who cannot tolerate systemic progesterone because of its adverse effects. Nevertheless, there has been no prospective multicenter trial that investigated the effectiveness of treatment with systemic progesterone in combination with intrauterine progesterone in young women with endometrial cancer.
Therefore, the investigators conducted a prospective trial of the treatment of the presumably early-stage grade 1 endometrial cancer in young women who desire to preserve fertility by using oral MPA in combination with LNG-IUS.
Young patients with histologically confirmed grade 1 endometrioid adenocarcinoma that is presumably confined to the endometrium, who desired to preserve fertility potential go through LNG-IUS insertion and are administered MPA at a dosage of 500 mg/d concurrently. Follow-up and treatment response assessment were implemented at a 3-month interval with office endometrial aspiration biopsy with LNG-IUS in place and dilatation and curettage after removal of LNG-IUS.
The primary endpoint is response rate. Secondary endpoint is to estimate the consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.
详细描述
PURPOSE: This prospective study aims to analyze the treatment efficacy of LNG-IUS plus MPA in Young Women with Early Stage Endometrial Cancer and to analyze the diagnostic accuracy of office endometrial aspiration biopsy with LNG-IUS in place compared with dilatation and curettage after removal of LNG-IUS.
ENDPOINTS: The primary endpoints of this study is response rate. Secondary endpoint is to estimate the consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.
STUDY SETTING AND PROTOCOL REVIEW: This study is a single arm, prospective multi-institutional study. Its protocol was approved by the Institutional Review Board of each clinical trial institution.
PLANNED CLINICAL TRIAL PERIOD: Patient Selection and Enrollment: 24 month after IRB approval of clinical trial Institution.
TREATMENT METHODS: Patients with histologically confirmed grade 1 endometrioid adenocarcinoma that is presumably confined to the endometrium went through LNG-IUS insertion and were administered MPA at a dosage of 500 mg/day concurrently. Follow-up and treatment response assessment were implemented at a 3-month interval with transvaginal ultrasonography, endometrial aspiration biopsy with LNG-IUS in place and D&C after removal of LNG-IUS. The biopsy findings are compared.
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
- — 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients younger than 40 years
- •Patients who are histological confirmed as endometrial adenocarcinoma grade I that is presumably confined to the endometrium based on the MRI evaluation
- •Patients who desire to preserve fertility potential
- •Patients signed the written informed consent voluntarily
排除标准
- •Patients who have severe underlying disease or complication
- •Under treatment of metastatic cancer from other organs or less than 5 years after previous cancer therapy
- •Acute liver disease or kidney disease
- •Thrombosis or phlebothrombosis requiring treatment, Hyperlipidemia, Smoker
结局指标
主要结局
response rate
时间窗: 24months after LNG-IUS insertion with taking oral MPA
Young patients with histologically confirmed grade 1 endometrioid adenocarcinoma that is presumably confined to the endometrium, who desired to preserve fertility potential go through LNG-IUS insertion and are administered MPA at a dosage of 500 mg/d concurrently. Follow-up and treatment response assessment were implemented at a 3-month interval with office endometrial aspiration biopsy with LNG-IUS in place and dilatation and curettage after removal of LNG-IUS.
次要结局
- consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.(every 3 month after LNG-IUS insertion with taking oral MPA)