A Phase II Study of Fractionated Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors
试验速览
- 阶段
- 2 期
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Response rate to SBRT
研究概览
简要总结
Patients with primary hepato-biliary malignancies or liver metastases from gastrointestinal cancer suffer substantial morbidity and mortality from their hepatic disease. Curative resection is feasible only for selected subgroups of patients. The majority of patients have unresectable and incurable disease. Aggressive arterial and systemic chemotherapy have been used in recent years with improved response and survival. However, a significant number of patients, at least one-third of patients with liver metastases from colorectal cancer and two-third or higher of unresectable hepatobiliary cancer, continue to die of liver failure from progressive disease in the liver. Percutaneous ethanol injections, chemoembolization, cryotherapy and thermal ablation using radiofrequency have been used to treat selected patients with smaller tumors (3-4 cm) in areas away from major blood vessels and the biliary tract. However, most unresectable liver cancers did not fit the criteria for these treatments. Therefore, other regional therapeutic option like external radiation therapy may be considered for local control in the liver or symptom palliation
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
- •Histologically conformation of liver malignancy
- •Solitary or multiple liver tumors amenable to SBRT
- •No jaundice or liver dysfunction
- •For metastases, the primary tumor site has been adequately treated.
- •For primary hepatoma, no extra-hepatic disease
- •Karnofsky > 70
排除标准
- •no extra-hepatic disease
- •Liver failure or inadequate liver function
- •Previous radiation therapy to the liver
- •lesions invading major blood vessels in the porta region
- •Contraindication to receive radiation therapy in the liver
结局指标
主要结局
Response rate to SBRT
时间窗: 3-6 Months
次要结局
- Treatment Related Toxicity(12 months)
