Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Trial of Palliative Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life

Conditions
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Breast Cancer, Metastatic Cancer, Pain, Prostate Cancer

Intervention / Treatment
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* Procedure: pain therapy
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3.0 Gy x 10 fractions in two weeks<br>3.0 Gy x 10 fractions for a total dose of 30.0 Gy in two weeks | Procedure: pain therapy<br> <br> Radiation: radiation therapy<br> <br> |
| Experimental: 8.0 Gy x 1 fraction<br>8.0 Gy x 1 fraction for a total dose of 8.0 Gy in a single dose | Procedure: pain therapy<br> <br> Radiation: radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer, stage IV prostate cancer, recurrent prostate cancer, bone metastases, pain