A Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- The Percentage of Patients With Local Control at 1 Year Post Treatment
研究概览
简要总结
This is a Phase II trial to characterize the safety and efficacy of individualized stereotactic body radiation therapy (SRBT) for patients who have had previous liver treatment or who have primary hepatocellular carcinoma (HCC).
详细描述
The trial endpoints are toxicity, survival and progression-free survival. DCE-MRI and plasma biomarkers will also be collected to explore their use as tools for treatment individualization in future trials. During the current trial, an indicator of liver function, indocyanine green (ICG), will be used to identify during treatment patients who are at excess risk for radiation-induced liver disease (RILD) so that their radiation dose may be reduced. The model used for individualization will be updated as trial data accrue, so this is an adaptive trial of an individualized therapy. The planned accrual is seventy (70) evaluable patients over three years.
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
- •over age 18
- •life expectancy of at least 12 weeks
- •Zubrod performance status of ≤
- •biopsy proven hepatocellular carcinoma (HCC)
- •liver metastases
- •a discrete hepatic tumor(s) as defined by the Barcelona46 criteria - for cirrhotic patients, (1) 2 imaging studies showing hypervascular tumor > 2cm, or (2) single imaging study showing hypervascular tumor > 2cm with AFP ≥ 400 ng/mL
- •a discrete hypervascular tumor present on two consecutive imaging studies (CT or MRI) with documented growth of > 1cm in diameter
- •adequate organ function
- •women and men not interested in pregnancy
- •must be recovered from the effects of any prior surgery, radiation therapy, chemotherapy and the effects of Radiofrequency Ablation (RFA) or Transcatheter Arterial Chemo Embolization (TACE)
- •minimum of 6 weeks following their last surgical procedure, radiation and chemotherapy.
排除标准
- •cannot be eligible for a curative liver resection
- •uncontrolled ascites clinically evident on physical exam
- •known allergy to IC-Green
- •known allergy to intravenous iodinated contrast agents
- •patients with poor venous access
- •patients with metastatic cancer with normal liver function who have not undergone previous liver directed therapy and a single tumor < 6 cm in size.
结局指标
主要结局
The Percentage of Patients With Local Control at 1 Year Post Treatment
时间窗: 1 Year
For this study, local control is defined as the lack of progressive local disease following CR (Complete Response) or PR (Partial Response), or lack of progressive local disease in patients with non-evaluable disease, who have no progressive elevation in serum tumor markers.
次要结局
- The Percentage of Patients Alive Without Progression at 1 Year(1 Year)
- The Percentage of Patients Alive at 1 Year(1 Year)
- The Number of Patients Who Experience Grade 4+ Hepatotoxicity(1 Year)
- The Number of Patients That Experience Grade 4+ Gastrointestinal Bleeding(1 Year)