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临床试验/NCT02334709
NCT02334709已完成1 期

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.

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2014年2月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Radiotherapie

Study Principal Investigator

University Hospital, Ghent

研究点 (2)

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