Breast Cancer Clinical Trial
Official title:
Randomized Trial of Palliative Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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