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About
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.
Full 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.
Enrollment
Sex
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Inclusion and exclusion 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:
Non-weight-bearing sites:
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:
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Hematopoietic:
Hepatic:
Renal:
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PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Primary purpose
Allocation
Interventional model
Masking
949 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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