Computed Tomography (CT) - Guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma (CEAL)
Phase-III-Study to Evaluate the Efficacy of CT-guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma.
Percutaneous, image-guided tumor ablation has evolved as a genuine alternative for the treatment of unresectable hepatocellular carcinoma. Published data exploring stereotactic or proton beam percutaneous irradiation have revealed,that hepatocellular carcinoma (HCC) is radiosensitive to certain protocols. In Phase I and II studies, the investigators investigated the potential role of local irradiation in primary and secondary liver tumors employing a Iridium192 source. The promising results of previous studies indicate that CT-guided brachytherapy might play a role in the treatment of unresectable HCC.
Therefore, the investigators started a randomized, controlled, clinical Phase-II study to evaluate the efficacy and survival-benefits of brachytherapy versus transarterial chemoembolization in patients with unresectable HCC.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Saxony-anhalt
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Magdeburg、Saxony-anhalt、德国、39120
- Clinic of Diagnostic Radiology and Nuclear Medicine, Medical Faculty, University Magdeburg
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参与标准
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
Inclusion Criteria:
- diagnosis of HCC by histopathology or according to the criteria of the Consensus Conference of the European Association for the Study of Liver Disease
- unresectable HCC
- Karnofsky-Index > 70
- estimated life expectancy > 16 weeks
- adequate bone marrow function
- adequate contraception for female patients
- informed consent
Exclusion Criteria:
- portal vein thrombosis on the tumor side
- extrahepatic spread
- Child C
- other untreated malignant disease
- general contraindication for chemotherapy
- active infectious disease
- neuropathy, platin-allergy
- pregnancy
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
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：brachytherapy
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catheter placed into the tumor by CT-guidance, radiation with iridium 192
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其他：TACE
transarterial chemoembolization
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application of doxorubicin and cisplatin in lipiodol into the tumor-feeding artery
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Time to untreatable progression
大体时间：the follow up period
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the follow up period
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Time to progression
大体时间：the follow up period
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the follow up period
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Overall survival
大体时间：the follow up period
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the follow up period
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合作者和调查者
调查人员
- 首席研究员：Jens Ricke, M.D.、Clinic of Diagnostic Radiology and Nuclear Medicine, University Magdeburg
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
CT-guided brachytherapy的临床试验
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The Second Hospital of Shandong University完全的
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Northwell HealthToshiba America Medical Systems, Inc.邀请报名