Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Prostate Cancer, Cancer, Cancer, Cancer, Cancer, Chronic Pain |
Therapuetic Areas: | Musculoskeletal, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | February 1998 |
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.
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.
- 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.
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
We found this trial at
235
sites
Baptist Hospital of Miami Since 1960, Baptist Hospital of Miami has been one of the...
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
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Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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10833 Le Conte Avenue # 8-950
Los Angeles, California 90095
Los Angeles, California 90095
(310) 825-5268
Jonsson Comprehensive Cancer Center at UCLA In the late 1960s, a group of scientists and...
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CCOP - Mount Sinai Medical Center The Mount Sinai Community Clinical Oncology Program (MSCCOP) is...
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Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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1400 South Orange Avenue
Orlando, Florida 32806
Orlando, Florida 32806
(407) 648-3800
M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
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Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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Naval Medical Center - Portsmouth Naval Medical Center Portsmouth, Virginia has proudly served the military...
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12902 USF Magnolia Dr
Tampa, Florida 33612
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Akron General Medical Center It
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Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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6701 North Charles Street
Baltimore, Maryland 21204
Baltimore, Maryland 21204
443-849-3051
Greater Baltimore Medical Center Cancer Center The Sandra & Malcolm Berman Cancer Institute's comprehensive, multidisciplinary...
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Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
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Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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CCOP - Columbus As one of the original 20 CCOPs, the Columbus Community Clinical Oncology...
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Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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