Hepatic Arterial Chemoembolization With Cisplatin or Internal Radiation Therapy in Treating Patients With Advanced Liver Cancer That Cannot Be Removed By Surgery
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)
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.
研究概览
地位
地位
干预/治疗
干预/治疗
详细说明
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.
OUTLINE: This is a randomized study. Patients are stratified according to extent of tumor in the liver (< 50% vs ≥ 50%) and presence of portal hypertension (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo trans-arterial chemoembolization comprising intra-arterial (IA) infusion of cisplatin over 30-60 minutes followed by embolization of the hepatic artery (that brings blood to the tumor) on day 1. Treatment repeats every 8-10 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive yttrium Y 90 glass microspheres (TheraSphere®) IA on day 1. Beginning 60 days after the first TheraSphere® treatment, patients may receive additional treatment with TheraSphere® only if follow-up CT scans show progressive disease.
Quality of life is assessed at baseline and then every 3 months thereafter.
After the completion of study treatment, patients are followed at 30 days and then every 2 months for 2 years.
PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study.
研究类型
研究类型
注册 (预期的)
注册
阶段
阶段
- 第三阶段
联系人和位置
学习地点
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15232
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
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参与标准
资格标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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:
Age
- 18 and over
Performance status
- ECOG 0-2
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
Hepatic
- 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
Renal
- Creatinine < 2.5 mg/dL
Cardiovascular
- No symptomatic congestive heart failure
- No severe peripheral vascular disease that would preclude catheterization
Other
- 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
Surgery
- Not specified
Other
- No other concurrent therapy for HCC
- No other concurrent investigational agents
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
研究衡量的是什么?
主要结果指标
主要结果指标
结果测量 |
|---|
|
Progression-free survival as assessed by tumor progression in the treated lobe of the liver
|
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Health-related quality of life at baseline and every 3 months
|
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Toxicity as measured by NCI CTCAE version 3.0
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合作者和调查者
调查人员
调查人员
- 学习椅:Brian I. Carr, MD、University of Pittsburgh
研究记录日期
研究主要日期
学习开始
学习开始
初级完成 (实际的)
初级完成
研究完成 (实际的)
研究完成
研究注册日期
首次提交
首次提交
首先提交符合 QC 标准的
首先提交符合 QC 标准的
首次发布 (估计)
首次发布
研究记录更新
最后更新发布 (估计)
最后更新发布
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
最后验证
最后验证
更多信息
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