Phase I/II Trial of Stereotactic Body Radiotherapy With Concurrent Fixed Dose Tyrosine Kinase Inhibitors in Metastatic Renal Cell Carcinoma: Dose Limiting Toxicity and Abscopal Effect.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Dose limiting toxicity
研究概览
简要总结
Tyrosine kinase inhibitors (TKIs) are often used in the standard treatment for patients with metastasized renal cell carcinoma. In addition to their ability to specifically inhibit tumor growth, TKIs also interfere with the vascularisation of the tumor. Unfortunately, most patients do not obtain long-lasting clinical benefit from this treatment. The goal of the current study is to enhance the effect of TKIs by combining them with stereotactic radiotherapy treatment of one of the metastases. This type of radiotherapy allows us to precisely irradiate the tumor with minimal effect on the surrounding healthy tissue. Recently it has been demonstrated that this type of radiotherapy stimulates the immune system to attack the tumor. By combining stereotactic radiotherapy with TKIs we expect to observe a reduction of metastases in a bigger population of patients.
In the first part of our study we focus on the safety of the combination therapy. In the second part we will evaluate the combined treatment response.
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
- •signed informed consent
- •diagnosis of RCC with clear-cell component histology
- •at least 3 extracranial measurable metastatic lesions per RECIST
- •Karnofsky Performance score >60
- •patients should have undergone cytoreductive treatment of their RCC at least 6 weeks prior to inclusion
- •patients should have adequate organ function for TKI treatment.
排除标准
- •prior systemic treatment for RCC
- •uncontrolled central nervous metastases
- •prior radiotherapy interfering with SBRT
- •any disorder precluding understanding of trial information.
结局指标
主要结局
Dose limiting toxicity
时间窗: 2 years
Dose limiting toxicity will be assessed before start of TKI, before SBRT, at the end of SBRT and at each follow-up visit
次要结局
- Immunomonitoring(4 years)
- Response rate(4 years)
研究者
Radiotherapie
Study Principal Investigator
University Hospital, Ghent
