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