Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer

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