Phase II Study of Combination Stereotactic Body Radiotherapy (SBRT) With Transarterial Chemo-Embolization (TACE) for Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Freedom From Local Progression of TACE and SBRT at 12 Months
研究概览
简要总结
To determine the efficacy and toxicity of TACE combined with SBRT
详细描述
Hepatocellular carcinoma (HCC) is the third most deadly cancer in the world. It is primarily seen in areas where hepatitis is endemic, such as Asia, but other risk factors include alcoholic cirrhosis.
Outcome of this disease is poor, mostly due to the fact that >80% of patients present with unresectable disease. Surgery or transplantation remain the only curative options. For the vast majority of patients who are unresectable, a variety of treatment options are available, including transarterial chemo-embolization (TACE), radiofrequency ablation, radioactive microspheres, microwave coagulation, laser-induced thermotherapy, and percutaneous alcohol injection, all of which have similar survival rates. Stereotactic body radiotherapy (SBRT) for unresectable HCC is a relatively new treatment option made available because of great improvements in diagnostic imaging and radiation delivery techniques. Although follow-up is limited, results show encouraging local control rates. Some investigators have combined TACE with fractionated radiotherapy as a means of intensifying local therapy, with some evidence of benefit.
TACE remains the dominant mode of local therapy for unresectable HCC. However, recurrence rates are high. The recent randomized trial suggests that a combination of local therapy (TACE and radiofrequency ablation [RFA]) is superior to either therapy alone, providing proof of principle that combined local treatment is most likely more effective for HCC. Because SBRT is rapidly becoming an accepted local therapy for hepatic lesions, its role in treating HCC needs to be further defined. Studies combining TACE and external beam radiotherapy have shown encouraging results, so the logical next step is to combine TACE with SBRT, which delivers a radiobiologically more intensive dose of radiation. However, toxicity data are lacking, since this combination has not been previously reported.
We propose to conduct a trial of trans-arterial chemo-embolization (TACE) and SBRT for unresectable HCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Freedom From Local Progression of TACE and SBRT at 12 Months
时间窗: 12 months
Freedom from local progression is defined as the time from start of treatment until the first occurrence of local progression. Local progression is defined as progression in the treated lesion according to the RECIST criteria. Progression outside the treated lesion and/or death will be considered as competing risks. The data was analyzed in a competing risk model with death as a competing risk. The outcome reported is the cumulative incidence at 12 months.
次要结局
- To Determine the Overall Survival of TACE and SBRT at 18 Months(18 months)
- Median Progression Free Survival(18 months)
- To Determine the Progression-free Survival of TACE and SBRT at 18 Months(18 months)
研究者
Daniel T. Chang
Associate Professor of Radiation Oncology (Radiation Therapy)
Stanford University