radiation therapy in treating patients with bone metastases from breast or prostate cancer

Conditions: Breast Cancer; Metastatic Cancer; Pain; Prostate Cancer

Summary: 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.

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. projected accrual: this study will accrue 938 patients within 2 years.

Eligibility criteria:
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) * femur * sacrum and/or sacroiliac joints * tibia * non-weight-bearing sites: * up to 5 consecutive cervical, thoracic, or lumbar vertebral bodies * lumbosacral spine * up to 3 consecutive ribs * humerus * fibula * radius with/without ulna * clavicle * scapula * pubis * 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: age: * 18 and over performance status: * karnofsky 40-100% life expectancy: * at least 3 months hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * 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) surgery: * no prior palliative surgery to treatment area * no planned surgical fixation of the bone

Keywords: stage iv breast cancer recurrent breast cancer stage iv prostate cancer recurrent prostate cancer bone metastases pain