NCT00041275已完成3 期
Randomized Double Blind Trial Of Megestrol Acetate Versus Placebo For The Treatment Of Inoperable Hepatocellular Carcinoma
National Medical Research Council (NMRC), Singapore22 个研究点 分布在 12 个国家目标入组 300 人开始时间: 2002年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 22
- 主要终点
- Survival measured weekly
研究概览
简要总结
RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using megestrol may fight liver cancer by blocking the uptake of estrogen. It is not yet known if megestrol is an effective treatment for liver cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in treating patients who have liver cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
- Compare the overall survival of patients with inoperable hepatocellular carcinoma treated with megestrol vs placebo.
- Compare the quality of life of patients treated with these drugs.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral megestrol twice daily for 1 year.
- Arm II: Patients receive an oral placebo twice daily for 1 year. Quality of life is assessed at baseline and then monthly for 1 year.
PROJECTED ACCRUAL: A minimum of 300 patients (200 for arm I and 100 for arm II) will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of hepatocellular carcinoma (HCC)
- •Histologically confirmed OR
- •Meets 2 of the following criteria:
- •Radiological evidence of HCC on CT scan, MRI, or ultrasound
- •Serum alpha-fetoprotein level at least 400 µg/L
- •Positive lipiodol retention
- •Not amenable to surgery
- •PATIENT CHARACTERISTICS:
- •20 to 100
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 5.8 mg/dL
- •Creatinine less than 1.7 mg/dL
- •Not pregnant
- •No clinical encephalopathy
- •No other malignancy within the past 5 years
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemoembolization for HCC
- •No prior systemic chemotherapy for HCC
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •See Disease Characteristics
- •No prior surgery for HCC
- •No prior percutaneous injection for HCC
排除标准
- 未提供
结局指标
主要结局
Survival measured weekly
次要结局
- Quality of life as measured by EORTC quality of life instrument monthly
研究者
研究点 (22)
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