A Prospectively Randomized Controlled Clinical Trial Comparing TheraSphere With Cisplatin-Based TACE (Trans Arterial Chemo Embolization) in the Management of Advanced Stage, Unresectable Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Progression-free survival as assessed by tumor progression in the treated lobe of the liver
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. In this case, chemotherapy is given through the artery (hepatic artery) that brings blood to the tumor. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether hepatic arterial chemoembolization with cisplatin is more effective than internal radiation therapy in treating liver cancer.
PURPOSE: This randomized phase III trial is studying hepatic arterial chemoembolization with cisplatin to see how well it works compared to internal radiation therapy in treating patients with advanced liver cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare time to disease progression in patients with unresectable advanced hepatocellular carcinoma treated with cisplatin-based trans-arterial chemoembolization vs hepatic intra-arterial yttrium Y 90 glass microspheres (TheraSphere®).
- Compare the health-related quality of life of patients treated with these regimens.
- Compare the safety of these regimens in these patients.
Secondary
- Compare survival of patients treated with these regimens.
- Compare tumor response by CT scan in patients treated with these regimens.
- Compare treatment-related costs, in terms of cost of therapy and number of hospitalization days, 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following:
- •Histologically or cytologically confirmed hepatocellular carcinoma (HCC)
- •Confined to the liver
- •Vascular liver mass in the presence of cirrhosis
- •Alpha-fetoprotein level > 500 ng/mL
- •Measurable disease
- •At least 1 unidimensionally measurable lesion > 20 mm by spiral CT scan
- •Unresectable disease, due to tumor size or extent or presence of cirrhosis
- •No metastatic disease, including brain metastases
- •Locoregional lymph node metastases allowed
- •No evidence of potential delivery of > 16.5 miCi (30 Gy absorbed dose) of radiotherapy to the lungs either during the first administration of yttrium Y 90 glass microspheres (TheraSphere®) or on cumulative delivery of radiation to the lungs over multiple treatments*
- •No evidence of detectable technetium Tc 99m macroaggregated albumin (Tc-99m MAA) flow to the stomach or duodenum after application of established angiographic techniques to stop the flow* NOTE: *For patients randomized to the TheraSphere® arm only
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •More than 12 weeks
- •Hematopoietic
- •WBC > 2,500/mm^3
- •Absolute neutrophil count > 1,500/mm^3
- •Platelet count > 60,000/mm^3
- •No bleeding diathesis not correctable by usual forms of therapy
- •See Disease Characteristics
- •Bilirubin < 2.0 mg/dL
- •AST and/or ALT ≤ 5 times upper limit of normal
- •Hepatitis allowed
- •No portal hypertension with hepatofugal flow
- •Creatinine < 2.5 mg/dL
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No severe peripheral vascular disease that would preclude catheterization
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective double barrier or hormonal contraception during and for at least 30 days after completion of study treatment
- •No ongoing or active infection
- •No other uncontrolled illness
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No more than 1 prior systemic chemotherapy for HCC
- •More than 4 weeks since prior IV chemotherapy and recovered
- •More than 1 year since prior hepatic arterial cisplatin
- •More than 4 months since other prior hepatic arterial chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior external hepatic radiotherapy for HCC
- 另有 3 项未显示
排除标准
- 未提供
结局指标
主要结局
Progression-free survival as assessed by tumor progression in the treated lobe of the liver
Health-related quality of life at baseline and every 3 months
Toxicity as measured by NCI CTCAE version 3.0
次要结局
未报告次要终点
研究者
Weijing Sun, MD, FACP
Professor
University of Pittsburgh