NCT00589030No Longer Available不适用
A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere (Yttrium-90 Glass Microspheres): A HDE Treatment Use Protocol
City of Hope Medical Center1 个研究点 分布在 1 个国家开始时间: 2007年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery.
PURPOSE: To provide expanded access and study the side effects of yttrium Y 90 glass microspheres in treating patients with liver cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with primary cancer to the liver and who are not surgical resection candidates.
- Evaluate patient experience and toxicities associated with TheraSphere® treatment.
- Enter treatment experience into a liver database.
Secondary
- Determine the tumor response rates in patients receiving this treatment.
研究设计
- 研究类型
- Expanded Access
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
- •Confirmed diagnosis of hepatocellular carcinoma
- •Surgical evaluation by a member of the Liver Tumor Program must conclude the patient is not a candidate for resection or ablation
- •Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0-2
- •Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
排除标准
- •Absolute granulocyte count =<1,500/ul
- •Platelet count =<75,000/ul
- •Serum creatinine >= 2.0 mg/dl
- •Serum bilirubin
- •>= 2.0 mg/dl for bilateral treatment or lobar treatment
- •>= 3.0 mg/dl for single lesion which could be treated by segmental fusion
- •History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine
- •Bleeding, diathesis not correctable by usual forms of therapy
- •Severe peripheral vascular disease that would preclude catheterization
- •Portal hypertension with portal venous shunt away from the liver
- •Evidence of potential delivery greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:
- •first TheraSphere administration; or
- •cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments
- •Evidence of any detectable Tc-99m MMA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow
- •Significant extrahepatic disease representing an imminent life-threatening outcome
- •Severe liver dysfunction (Childs' Classification C) or pulmonary insufficiency (requiring continuous oxygen therapy)
- •Active uncontrolled infection
- •Significant underlying medical or psychiatric illness
- •Pregnant women may not participate
- •Children may not participate
研究者
研究点 (1)
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