Phase-III-Study to Evaluate the Efficacy of CT-guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Time to untreatable progression
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •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
排除标准
- •portal vein thrombosis on the tumor side
- •extrahepatic spread
- •other untreated malignant disease
- •general contraindication for chemotherapy
- •active infectious disease
- •neuropathy, platin-allergy
- •pregnancy
结局指标
主要结局
Time to untreatable progression
时间窗: the follow up period
次要结局
- Time to progression(the follow up period)
- Overall survival(the follow up period)
研究者
Jens Ricke
Prof. Jens Ricke
University of Magdeburg