Breast Cancer, Metastatic Cancer, Pain, Prostate Cancer
Conditions
Keywords
stage IV breast cancer, recurrent breast cancer, stage IV prostate cancer, recurrent prostate cancer, bone metastases, pain
Brief 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.
Detailed description
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.
Interventions
PROCEDUREpain therapy
RADIATIONradiation therapy
Sponsors
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Radiation Therapy Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
Canada, United States
Outcome results
None listed