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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
February 1, 1998
Primary Completion Date
July 1, 2003
Last Updated
November 17, 2015
949
ACTUAL participants
pain therapy
PROCEDURE
radiation therapy
RADIATION
Lead Sponsor
Radiation Therapy Oncology Group
Collaborators
NCT04704661
NCT05245812
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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