Randomized Trial of Palliative Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life
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:
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:
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:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Birmingham, Alabama 35294-3300, United States
Duarte, California 91010-3000, United States
Los Angeles, California 90033-0804, United States
Indianapolis, Indiana 46202, United States
Lexington, Kentucky 40536-0084, United States
Baltimore, Maryland 21231-2410, United States
Jamaica Plain, Massachusetts 02130, United States
Mount Holly, New Jersey 08060, United States
Brooklyn, New York 11203, United States
Syracuse, New York 13217, United States
Winston-Salem, North Carolina 27157-1082, United States
Philadelphia, Pennsylvania 19107-5541, United States
St. John's, Newfoundland and Labrador A1B 3V6, Canada