Status:
COMPLETED
Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Conditions:
Breast Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 tr...
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 canc...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
949 Patients enrolled
Trial Details
Trial ID
NCT00003162
Start Date
February 1 1998
Last Update
November 17 2015
Active Locations (253)
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1
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
2
Huntsville Hospital System
Huntsville, Alabama, United States, 35801-4470
3
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States, 35801
4
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688