Radiation Therapy in Treating Patients With 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.

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