Phase III Study of Palliative Radiotherapy for Bone Metastases Comparing Single to Multiple Fractions.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Pain relief
研究概览
简要总结
The aim of the investigators study was to determine whether 8 Gy in a single fraction provides equivalent pain and narcotic relief compared to 30 Gy in 10 fractions for patients with painful bone metastases.
The secondary objectives were to evaluate the frequency, duration of pain relief, narcotic relief, toxicity and the effect on quality of life measures for each of the two treatment arms.
详细描述
This prospective, phase III, randomized study was conducted by department of radiation oncology at Marilia Medicine School, São Paulo, Brazil.
Eligibility requirements included:
Age of 18 years or older, histologically proven primary malignancy of any histological type, radiographic evidence of bone metastasis, pain corresponding to the area of bone metastasis, a Karnofsky performance status of at least 40, and an estimated life expectancy of at least 1months.
Histologic diagnosis was established from needle biopsy, bone marrow biopsy, cytology, or a surgical biopsy or resection.
Radiographic evidence of bone metastasis was required and performed within 8 weeks prior to randomization. Acceptable studies included plain radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance imaging. Other studies were acceptable with the approval of the principal investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age of 18 years or older, histologically proven primary malignancy of any histological type, radiographic evidence of bone metastasis, pain corresponding to the area of bone metastasis, a Karnofsky performance status of at least 40, and an estimated life expectancy of at least 1 month.
- •Histologic diagnosis was established from needle biopsy, bone marrow biopsy, cytology, or a surgical biopsy or resection. Radiographic evidence of bone metastasis was required and performed within 8 weeks prior to randomization.
排除标准
- •The patient was ineligible if the systemic agent commences within the 30 days prior to registration.
- •This includes hormonal therapy, chemotherapy, and immunotherapy.
- •Patients were ineligible if the painful area had received prior radiation therapy or palliative surgery, if there was pathologic fracture or impending fracture of the treatment site, or if there was planned surgical fi xation of the bone.
- •Patients with clinical or radiographic evidence of spinal cord or cauda equina compression and/or effacement were not eligible.
结局指标
主要结局
Pain relief
次要结局
- duration of pain relief, narcotic relief, toxicity and the effect on quality of life measures for each of the two treatment arms.