NCT00192777Unknown2 期
Concurrent Xeloda and Radiotherapy for Bone Metastases
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The frequency of pain relief for the proposed regimen, using a scale that takes into account the subjective feeling and the use of analgesics
研究概览
简要总结
Hypothesis: Radiosensitization using Xeloda should improve the rate of complete pain relief.
Primary Objective:
- To determine the frequency of pain relief for the proposed regimen.
Secondary Objective(s):
- To determine the duration of pain relief and narcotic relief for the proposed regimen.
- To determine the frequency of narcotic relief for the proposed regimen.
- To determine the toxicity of concurrent UFT and radiotherapy in patients with bone metastases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •The patient must be 18 years of age or older.
- •The patient must have epithelial malignancy.
- •Radiographic evidence of bone metastasis is required. Acceptable studies include plain radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance imaging.
- •The patient must have pain that appears to be related to the radiographically documented metastasis.
- •Patients must have an estimated life expectancy of 3 months or greater.
- •Signed study-specific informed consent.
- •Karnofsky performance status
- •Calculated creatinine clearance > 50 ml/min
排除标准
- 未提供
结局指标
主要结局
The frequency of pain relief for the proposed regimen, using a scale that takes into account the subjective feeling and the use of analgesics
时间窗: after 3 months
次要结局
- The duration of pain relief and narcotic relief for the proposed regimen after one year
- The frequency of narcotic relief for the proposed regimen after one year
- The toxicity of concurrent UFT and radiotherapy in patients with bone metastases after one year
研究者
研究点 (2)
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