NCT00079027Unknown3 期
A Randomized Clinical Trial Evaluating the Benefits of Doxorubicin Chemoembolization Versus Systemic Doxorubicin in Patients With Unresectable, Advanced Hepatocellular Carcinoma
University Hospital Birmingham20 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2004年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 280
- 试验地点
- 20
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping the cells from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. It is not yet known whether doxorubicin is more effective with or without chemoembolization in treating unresectable hepatocellular carcinoma (liver cancer).
PURPOSE: This randomized phase III trial is studying doxorubicin given by infusion to see how well it works compared to doxorubicin given by chemoembolization in treating patients with advanced liver cancer than cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare the survival of patients with advanced unresectable primary hepatocellular carcinoma treated with intravenous doxorubicin hydrochloride vs doxorubicin hydrochloride chemoembolization.
Secondary
- Compare the response rate in patients treated with these regimens.
- Compare time to progression in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the health economic implications of these regimens in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed hepatocellular carcinoma (HCC)
- •Advanced, unresectable disease
- •No clinically significant ascites
- •No modified Child-Pugh class C liver disease
- •No main portal vein occlusion/involvement
- •No extrahepatic tumor of any kind
- •PATIENT CHARACTERISTICS:
- •18 and over (16 and over for patients residing in Scotland)
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Hemoglobin ≥ 8.5 g/dL
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin < 5.0 mg/dL
- •Transaminases < 2.5 times upper limit of normal (ULN)
- •INR < 1.5
- •Creatinine < 2 times ULN
- •Cardiovascular
- •No New York Heart Association class III or IV cardiac disease
- •No acute angina
- •No significant peripheral vascular disease
- •No thrombosis of main portal vein
- •LVEF ≥ 50%
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other concurrent serious medical condition
- •No serious infection
- •No psychological, familial, sociological, or geographical factors that would preclude study compliance
- •No other malignancy within the past 5 years except carcinoma in situ of the cervix or non-melanoma skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior biologic therapy for advanced unresectable HCC
- •Chemotherapy
- •No prior systemic or regional chemotherapy
- •No prior chemotherapy for advanced unresectable HCC
- •No other concurrent anticancer chemotherapy
- •Endocrine therapy
- •No prior hormonal therapy for advanced unresectable HCC
- •Radiotherapy
- •No prior radiotherapy for advanced unresectable HCC
- •No other concurrent anticancer radiotherapy
- •More than 7 days since prior major surgery
- •More than 3 days since prior laparoscopy
- •More than 4 weeks since prior investigational agents
- •More than 6 weeks since prior ablative therapy and must have radiological evidence of progression if ablated site is the only site of disease
- •No other concurrent investigational agents
排除标准
- 未提供
结局指标
主要结局
Overall survival
次要结局
- Overall response
- Quality of life as assessed by EORTC QOL QLQ-30 and EORTC QLQ HCC18 at baseline and 10 and 24 weeks
- Time to progression as assessed by RECIST criteria
- Toxicity
- Health economics
- Proteomic and immunological analysis
研究者
研究点 (20)
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