Phase I/II Study of Proton Beam Therapy for Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- 3-year Survival Without Tumor Progression for Patients Within the Milan Criteria
研究概览
简要总结
This study is designed to evaluate the possible benefits and side effects of the use of proton therapy for patients with hepatocellular carcinoma.
详细描述
Hepatocellular carcinoma (HCC) is a type of primary cancer of the liver that is being diagnosed in the U.S. population with increasing frequency. While surgery is the first line of treatment, many patients are not eligible for surgical removal. Current non-surgical treatments for HCC are not fully effective and can have substantial side-effects. This study utilizes a type of radiation treatment called proton beam that can deliver high doses of radiotherapy to tumors within the liver while minimizing damage to surrounding healthy tissues. The treatment is non-invasive and is given on an out-patient basis over a three week coarse. The study will evaluate the effectiveness and side-effects of this therapy by tracking patient's outcomes following treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Diagnosis of hepatocellular carcinoma
- •Adult patients aged 18 years old and above
- •Ability to give informed consent for study
- •Compensated liver disease
排除标准
- •Pediatric patients (aged less than 18 years old)
- •Decompensated or advanced liver disease
- •Poorly controlled ascites
- •Variceal hemorrhage within the previous 30 days
- •Recurrent hepatic encephalopathy
- •Cirrhosis with CTP* score >10
- •Active alcohol or drug abuse
- •Anticipated survival of less than 30 days
- •Advanced co-morbid medical illnesses
- •Karnofsky Performance Score <60
- •Tumor characteristics:
- •Any tumor that can not be safely and effectively irradiated due to inability to deliver target treatment dose to required treatment volume or due to prohibitively high risk of anticipated toxicities to normal liver or nearby bowel, stomach, kidney or spinal cord.
结局指标
主要结局
3-year Survival Without Tumor Progression for Patients Within the Milan Criteria
时间窗: 3 months
Percent of participants alive and without tumor progression 3 years following treatment.
Median Survival Without Tumor Progression
时间窗: 3 months
Median time until disease progression or death
次要结局
未报告次要终点
研究者
David Bush
Principal Inverstigator
Loma Linda University