NCT00082927已完成3 期
A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 580
- 试验地点
- 52
研究概览
简要总结
RATIONALE: Ibandronate may be effective in reducing bone pain caused by metastatic cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether ibandronate is more effective than standard treatment with radiation therapy in treating metastatic bone pain.
PURPOSE: This phase III randomized clinical trial is studying ibandronate to see how well it works compared to single-dose local radiation therapy in treating patients with localized metastatic bone pain.
详细描述
OBJECTIVES:
Primary
- Compare pain response at 4 and 12 weeks post-treatment in patients with localized metastatic bone pain treated with single-dose ibandronate vs single-dose local radiotherapy .
Secondary
- Compare the quality of life of patients treated with these regimens.
- Correlate urinary markers of osteoclast activity (pyridinoline and deoxypyridinoline) with the clinical outcome of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed primary prostate cancer OR sclerotic bone metastases (for patients with serum prostate-specific antigen > 100 ng/mL)
- •Radiologically confirmed bone metastases by plain x-ray, isotope scan, CT scan, or MRI
- •Clinical diagnosis of metastatic bone pain for which radiotherapy is indicated
- •Single localized metastatic bone pain AND receiving optimal analgesics and adjuvant drugs, including non-steroidal anti-inflammatory drugs, unless contraindicated
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status
- •Not specified
- •Performance status
- •Not specified
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Not specified
- •Not specified
- •Creatinine ≤ 3.0 mg/dL
- •No hypercalcemia (corrected calcium > 10.8 mg/dL)
- •No hypocalcemia (corrected calcium < 8.2 mg/dL)
- •No known hypersensitivity to ibandronate or other bisphosphonates
- •No history of aspirin-sensitive asthma
- •Able to comply with pain chart and quality of life assessments
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •More than 4 weeks since prior change in systemic chemotherapy
- •No prior high-dose chemotherapy (dose intensity > 3 times standard dose)
- •Endocrine therapy
- •More than 4 weeks since prior change in hormonal therapy
- •Radiotherapy
- •See Disease Characteristics
- •No prior external beam radiotherapy to index site
- •No prior systemic radioisotope therapy (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
- •Not specified
- •More than 6 months since prior bisphosphonate treatment
- •More than 4 weeks since prior aminoglycoside antibiotics
- •More than 30 days since prior investigational drugs
排除标准
- 未提供
研究者
研究点 (52)
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