A Phase I/II Study of Sorafenib and Palliative Radiotherapy in Patients With Advanced Renal Cell Carcinoma and Symptomatic Bony Metastases
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Reduction in pain from index lesion 4 weeks following the completion of radiotherapy, assessed using Brief Pain Inventory.
研究概览
简要总结
The purpose of this study is to investigate the use of a new anti-angiogenic drug called sorafenib, in combination with radiotherapy, for renal cell cancer that has spread to the bone and is causing significant pain. The study will find a safe dose of sorafenib for this combination study treatment, look at side effects, and test if the study treatment is effective in controlling the pain experienced from this type of renal cell cancer. . There will be two parts or phases to this study
The purpose of the first phase is to find the highest dose of sorafenib that can be given safely to patients, when combined with radiotherapy. We will also see what kind of effects the study treatment has on you and your cancer. Participants in this phase will receive a dose of sorafenib that has shown to be well-tolerated in humans. If the side effects are tolerable for this dose of sorafenib when combined with radiotherapy, new patients will be asked to join the study and will receive a dose of sorafenib higher than the last study participant.
In the second phase, new study participants will receive the dose of sorafenib that was determined to be safe in the first phase. Side effects will continue to be looked at and the effectiveness on controlling pain symptoms from this type of cancer, will also be looked at.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sorafenib and palliative radiotherapy
干预措施: Sorafenib (Drug)
Sorafenib and palliative radiotherapy
干预措施: external beam radiotherapy (Radiation)
结局指标
主要结局
Reduction in pain from index lesion 4 weeks following the completion of radiotherapy, assessed using Brief Pain Inventory.
时间窗: 7 weeks
次要结局
- reduction in pain in index lesion at study termination assessed using Brief Pain Inventory(12 weeks)
- acute toxicity of palliative radiotherapy and sorafenib together(12 weeks)
- acute toxicity of sorafenib alone(1 week)
- biologic response of the index lesion to radiotherapy and sorafenib assessed using FDG-PET-CT(7 weeks)
- disease-free survival(greater than 3 months)