Randomized Trial of Palliative Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life
pain therapy
+ radiation therapy
+ pain therapy
Urogenital Diseases+18
+ Genital Diseases
+ Breast Diseases
Supportive Care Study
Summary
Study start date: February 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.949 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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: Pelvis (excluding pubis) Femur Sacrum and/or sacroiliac joints Tibia Non-weight-bearing sites: Up to 5 consecutive cervical, thoracic, or lumbar vertebral bodies Lumbosacral spine Up to 3 consecutive ribs Humerus Fibula Radius with/without ulna Clavicle Scapula Pubis 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: 18 and over Performance status: Karnofsky 40-100% Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No impending fracture of the treatment site No hematologic primary malignancies Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: No change in immunotherapy within 30 days Chemotherapy: No change in chemotherapy within 30 days Endocrine therapy: No change in hormonal therapy within 30 days Radiotherapy: No prior radiation therapy to treatment area At least 30 days since systemic radiotherapy (Sr 89) Surgery: No prior palliative surgery to treatment area No planned surgical fixation of the bone
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 253 locations
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, United StatesOpen University of Alabama at Birmingham Comprehensive Cancer Center in Google MapsHuntsville Hospital System
Huntsville, United StatesComprehensive Cancer Institute of Huntsville
Huntsville, United StatesMBCCOP - Gulf Coast
Mobile, United States