Randomized Trial of Palliative Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 949
- 试验地点
- 253
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective for bone metastases.
PURPOSE: Randomized phase III trial to compare different radiation therapy regimens in treating patients who have bone metastases from breast or prostate cancer.
详细描述
OBJECTIVES:
- Compare the ability of a single fraction of radiation therapy vs multiple fractions to provide complete pain relief in patients with painful bone metastases from breast or prostate cancer.
- Determine the frequency and duration of pain relief and narcotic relief after these treatments in these patient populations.
- Compare the effect on quality of life of these two treatments in these patient populations.
- Compare the incidence of pathologic fracture within the treatment fields after these two treatments in these patient populations.
OUTLINE: This is a randomized study.
Patients are assigned to 1 of 2 treatment arms. Arm I consists of radiation therapy delivered in 10 fractions over 2 weeks. Arm II consists of a single dose of radiation therapy. Any retreatment does not occur until at least 4 weeks after prior treatment unless there is an increase of 2 points on the pain score.
Patients are followed and quality of life is assessed at 2 and 4 weeks, then at 2, 3, 6, 9, and 12 months, every 6 months for the next 3 years, then annually until death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 proven breast or prostate cancer
- •Radiographic evidence of bone metastasis within 8 weeks of study
- •Eligible treatment sites:
- •Weight-bearing sites:
- •Pelvis (excluding pubis)
- •Sacrum and/or sacroiliac joints
- •Non-weight-bearing sites:
- •Up to 5 consecutive cervical, thoracic, or lumbar vertebral bodies
- •Lumbosacral spine
- •Up to 3 consecutive ribs
- •Radius with/without ulna
- •If multiple sites are treated, site is included as weight bearing if any of the sites include the pelvis, sacrum, femur, or tibia
- •Worst pain score of at least 5 on a scale of 10
- •No skull, feet, or hand metastases
- •No spinal cord or cauda equina compression/effacement in vertebral metastases
- •Multiple sites eligible if they can be included in no greater than 3 treatment sites
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 40-100%
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •No impending fracture of the treatment site
- •No hematologic primary malignancies
- •Negative pregnancy test
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No change in immunotherapy within 30 days
- •Chemotherapy:
- •No change in chemotherapy within 30 days
- •Endocrine therapy:
- •No change in hormonal therapy within 30 days
- •Radiotherapy:
- •No prior radiation therapy to treatment area
- •At least 30 days since systemic radiotherapy (Sr 89)
- •No prior palliative surgery to treatment area
- •No planned surgical fixation of the bone
排除标准
- 未提供
研究组 & 干预措施
3.0 Gy x 10 fractions in two weeks
3.0 Gy x 10 fractions for a total dose of 30.0 Gy in two weeks
干预措施: pain therapy (Procedure)
3.0 Gy x 10 fractions in two weeks
3.0 Gy x 10 fractions for a total dose of 30.0 Gy in two weeks
干预措施: radiation therapy (Radiation)
8.0 Gy x 1 fraction
8.0 Gy x 1 fraction for a total dose of 8.0 Gy in a single dose
干预措施: pain therapy (Procedure)
8.0 Gy x 1 fraction
8.0 Gy x 1 fraction for a total dose of 8.0 Gy in a single dose
干预措施: radiation therapy (Radiation)