Randomized trial of doxorubicin beads for arterial embolization of hepatocellular

阿霉素珠用于肝细胞动脉栓塞的随机试验

基本信息

  • 批准号:
    7276297
  • 负责人:
  • 金额:
    $ 22.65万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2007
  • 资助国家:
    美国
  • 起止时间:
    2007-06-01 至 2009-05-31
  • 项目状态:
    已结题

项目摘要

DESCRIPTION (provided by applicant): Hepatocellular cancer (HCC) is the 5th most common cancer in the world, and has become more common with the increased incidence of hepatitis C. Transcatheter chemoembolization (TACE) has become the standard treatment for patients with unresectable HCC, despite the lack of evidence demonstrating the superiority of TACE compared to embolization without chemotherapy. There are financial and toxicity concerns associated with the use of chemotherapy that make it important to define the best method of arterial emboliztion for HCC. A microscopic bead has been developed that can be loaded with doxorubicin and used for hepatic arterial embolization, resulting in high prolonged concentration of drug within the tumor. To assess the role of doxorubicin in hepatic arterial embolization of HCC, we will conduct the first randomized trial to determine the difference in response to treatment, time to progression and overall survival using a plain bead versus the bead loaded with 150 mg of doxorubicin. In Aim 1 we propose to characterize the radiologic response to treatment as manifest by change in viable tumor on contrast enhanced CT scans. Aim 2 is designed to validate an automated CT volumetric method of assessing tumor necrosis, and correlate this method with conventional means of assessing response to treatment. Aim 3 will establish whether use of the drug eluting bead increases the time to progression or survival, and whether response to treatment, as estimated by development of tumor necrosis on the initial post-treatment CT scans, can be used as a surrogate biomarker for outcome. This study is important because it will provide objective data regarding the role of doxorubicin in hepatic arterial embolization, and justification for the increased cost of the embolic agent. What we learn about toxicity will likely change the way that chemotherapeutic agents are administered transarterially, not just for HCC but for any hypervascular liver tumor. Targeting chemotherapy to liver tumors has the potential to have a significant impact on clinical outcome, and may improve the overall survival of patients for whom there is no other recognized treatment. The validation of a new imaging method of assessing response to treatment that might replace current less sensitive methods is important for all cancer patients and cancer investigators The incidence of hepatocellular carcinoma (HCC) in the United States is increasing. The vast majorities of patients are not operative candidates at the time of diagnosis, and are treated with hepatic arterial therapies. Controversy exists regarding the need to use chemotherapeutic agents for intra-arterial treatment. The use of chemotherapy adds not only expense, but potential toxicity. This study is designed to determine the incremental value of arterial chemotherapy, as well as to validate an automated imaging method of assessing response to treatment.
描述(由申请人提供):肝细胞癌(HCC)是世界上第五大常见癌症,随着丙型肝炎发病率的增加,HCC的发病率也越来越高,经导管化疗栓塞(TACE)已成为不可切除HCC患者的标准治疗方法,尽管缺乏证据表明TACE与不化疗的栓塞相比具有优势。由于与化疗相关的经济和毒性问题,确定HCC动脉栓塞的最佳方法非常重要。已经开发出一种微型微珠,可以装载阿霉素并用于肝动脉栓塞,导致肿瘤内的药物高浓度延长。为了评估阿霉素在HCC肝动脉栓塞中的作用,我们将进行第一个随机试验,以确定使用普通头部与加载150 mg阿霉素的头部在治疗反应、进展时间和总生存期方面的差异。在目的1中,我们建议通过增强CT扫描上存活肿瘤的变化来表征对治疗的放射学反应。目的2旨在验证评估肿瘤坏死的自动CT体积测量方法,并将该方法与评估治疗反应的传统方法相关联。目的3将确定药物洗脱珠的使用是否会增加进展或生存时间,以及通过治疗后初始CT扫描中肿瘤坏死的发展来估计的治疗反应是否可以用作结果的替代生物标志物。这项研究很重要,因为它将提供关于阿霉素在肝动脉栓塞中的作用的客观数据,并为栓塞剂增加的成本提供理由。我们对毒性的了解可能会改变化疗药物经动脉给药的方式,不仅仅是HCC,而是任何高血管性肝肿瘤。靶向肝肿瘤化疗有可能对临床结果产生重大影响,并可能提高没有其他公认治疗方法的患者的总体生存期。对所有癌症患者和癌症研究人员来说,验证一种新的评估治疗反应的影像学方法可能取代目前敏感度较低的方法是很重要的。绝大多数患者在诊断时不适合手术,并接受肝动脉治疗。关于是否需要使用化疗药物进行动脉内治疗存在争议。化疗的使用不仅增加了费用,而且增加了潜在的毒性。本研究旨在确定动脉化疗的增量价值,并验证一种评估治疗反应的自动成像方法。

项目成果

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Karen Teresa Brown其他文献

Karen Teresa Brown的其他文献

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{{ truncateString('Karen Teresa Brown', 18)}}的其他基金

Randomized trial of doxorubicin beads for arterial embolization of hepatocellular
阿霉素珠用于肝细胞动脉栓塞的随机试验
  • 批准号:
    7431576
  • 财政年份:
    2007
  • 资助金额:
    $ 22.65万
  • 项目类别:

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