Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer
- Conditions
- Breast CancerPainProstate CancerMetastatic Cancer
- Registration Number
- NCT00003162
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 949
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (253)
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Huntsville Hospital System
🇺🇸Huntsville, Alabama, United States
Comprehensive Cancer Institute of Huntsville
🇺🇸Huntsville, Alabama, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Alabama Oncology, LLC
🇺🇸Montgomery, Alabama, United States
Radiation Oncology Associates of West Alabama
🇺🇸Tuscaloosa, Alabama, United States
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Mount Diablo Medical Center
🇺🇸Concord, California, United States
Cancer Center and Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
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