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

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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.

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
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New Orleans, Louisiana 70112
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Baltimore, Maryland 21231
410-955-6190
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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33 Villa Road, Suite 400
Greenville, South Carolina 29615
(864) 404-2045
CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
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
(310) 825-5268
Jonsson Comprehensive Cancer Center at UCLA In the late 1960s, a group of scientists and...
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300 Community Drive
Manhasset, New York 11030
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1331 Union Ave # 800
Memphis, Tennessee 38103
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4300 Alton Road
Miami Beach, Florida 33140
(305) 674-2625
CCOP - Mount Sinai Medical Center The Mount Sinai Community Clinical Oncology Program (MSCCOP) is...
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
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
(407) 648-3800
M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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620 John Paul Jones Cir
Portsmouth, Virginia 23708
(757) 953-5008
Naval Medical Center - Portsmouth Naval Medical Center Portsmouth, Virginia has proudly served the military...
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800 West 5th Avenue
Spokane, Washington 99210
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
Akron General Medical Center It
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Akron, Ohio 44304
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Albuquerque, New Mexico 87109
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
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Amarillo, Texas 79106
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Anderson, Indiana 46016
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Ann Arbor, Michigan 48106
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
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Annapolis, Maryland 21401
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Arlington Heights, Illinois 60005
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Atlanta, Georgia 30322
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Atlanta, Georgia 30342
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Baltimore, Maryland 21225
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6701 North Charles Street
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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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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Baton Rouge, Louisiana 70809
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Bennington, Vermont 05201
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Bethlehem, Pennsylvania 18015
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Billings, Montana 59101
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Binghamton, New York 13905
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Bismarck, North Dakota 58501
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601 West 2nd Street
Bloomington, Indiana 47402
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506 6th St
Brooklyn, New York 11215
(718) 780-3000
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Burlington, Vermont 05405
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Camden, New Jersey 08103
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Cedar Rapids, Iowa 52403
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Chapel Hill, North Carolina 27599
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Charlottesville, Virginia 22908
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
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Cleveland, Ohio 44106
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
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2049 E 100th St
Cleveland, Ohio 44106
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Clifton Springs, New York 14432
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Colorado Springs, Colorado 80909
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Columbia, Missouri 65203
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1335 Dublin Road, Suite 124A
Columbus, Ohio 43215
(614) 488-2118
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Concord, California 94524
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Concord, North Carolina 28025
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
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Darby, Pennsylvania 19023
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Decatur, Illinois 62526
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Denver, Colorado 80010
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300 East Locust St., Ste 350
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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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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East Orange, New Jersey 07018
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East Stroudsburg, Pennsylvania 18301
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Edison, New Jersey 08818
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Elizabeth, New Jersey 07201
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Flint, Michigan 48532
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Fresno, California 93720
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Fresno, California 93720
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1600 Southwest Archer Road
Gainesville, Florida 32610
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2635 North 7th Street
Grand Junction, Colorado 81502
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Green Bay, Wisconsin 54301
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Green Bay, Wisconsin 54301
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Greenbrae, California 94904
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Greenville, North Carolina 27858
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Harrisonburg, Virginia 22801
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
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Hershey, Pennsylvania 17033
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Honolulu, Hawaii 96813
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
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Huntsville, Alabama 35801
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Hyannis, Massachusetts 02601
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Indianapolis, Indiana 46206
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Indianapolis, Indiana 46219
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