A Phase 1b Study of Safety and Preliminary Efficacy of Stereotactic Body Radiation Therapy (SBRT) in Patients With Metastatic Renal Cell Carcinoma Treated With Targeted or Immuno- Therapy (Volga Study).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Rate of adverse events of SBRT
研究概览
简要总结
Aim of this phase 1b study is to evaluate safety and preliminary efficacy of stereotactic body radiation therapy in patients with metastatic renal cell carcinoma treated with VEGFR, mTOR or immune checkpoint inhibitors.
详细描述
This is prospective phase 1b study.
Patients with metastatic RCC receiving targeted or IO therapy (VEGFR inhibitor or mTOR inhibitor or checkpoint inhibitors in approved treatment lines and in standard therapeutic regimens) with stable diseaseor durable partial response for at least 4 months, are enrolled in the study.
The initial examination includes CT with contrast, where the selected measured 2 metastatic sites, stable for at least 4 months but no more than 6 months of targeted therapy (increase or decrease in size in the course of targeted therapy should not exceed 10%). Metastases have to be located in one organ. Allowed location of metastases: lungs, liver, lymph nodes, contralateral kidney, adrenal gland.
Size of selected metastases should not be less than 5 mm and not more than 4 cm.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clear cell renal cell carcinoma
- •confirmed distant metastases
- •previous nephrectomy
- •stable disease or durable partial response on recommended targeted and IO therapy
- •age: > 18 years
- •signed informed consent
排除标准
- •unability to select first and second metastases
- •history of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or other severe cardiovascular disease (i.e., New York Heart Association class III or IV)
- •other malignancy
- •grade 3 and 4 toxicity of targeted therapy
研究组 & 干预措施
Stereotactic Body Radiation Therapy
Patients with stable disease on targeted or IO therapy will receive SBRT on first metastasis of clear cell renal cell carcinoma. Second metastasis will be as a control. In case of safety and 50% reduction in size of first metastasis, up to 10 metastasis will be treated with SBRT.
干预措施: SBRT (Radiation)
结局指标
主要结局
Rate of adverse events of SBRT
时间窗: 4 months
次要结局
- Rate of reduction in size of first metastasis exposed to radiation(4 months)
- Time to progression of first (study) and second (control) metastases(8 months)