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

Phase 3
18 Years
Not Enrolling
Breast Cancer, Metastatic Cancer, Pain, Prostate Cancer

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Trial Information

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


- 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

- 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.

Inclusion Criteria


- 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

- Nonweight 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



- 18 and over

Performance status:

- Karnofsky 40-100%

Life expectancy:

- At least 3 months


- Not specified


- Not specified


- Not specified


- No impending fracture of the treatment site

- No hematologic primary malignancies

- Negative pregnancy test


Biologic therapy:

- No change in immunotherapy within 30 days


- No change in chemotherapy within 30 days

Endocrine therapy:

- No change in hormonal therapy within 30 days


- No prior radiation therapy to treatment area

- At least 30 days since systemic radiotherapy (Sr 89)


- No prior palliative surgery to treatment area

- No planned surgical fixation of the bone

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

William F. Hartsell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Lutheran General Hospital


United States: Federal Government

Study ID:




Start Date:

February 1998

Completion Date:

Related Keywords:

  • Breast Cancer
  • Metastatic Cancer
  • Pain
  • Prostate Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • bone metastases
  • pain
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Prostatic Neoplasms



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Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
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University of Rochester Cancer Center Rochester, New York  14642
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
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East Carolina University School of Medicine Greenville, North Carolina  27858-4354
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CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Sinai Hospital of Baltimore Baltimore, Maryland  21225
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
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Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
MD Anderson Cancer Center Orlando Orlando, Florida  32806
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CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
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University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
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Cancer Center at the University of Virginia Charlottesville, Virginia  22908
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Medical College of Wisconsin Milwaukee, Wisconsin  53226
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Alabama Oncology, LLC Montgomery, Alabama  36106-2801
Radiation Oncology Associates of West Alabama Tuscallosa, Alabama  35401
Mount Diablo Medical Center Concord, California  94524-4110
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Saint Agnes Cancer Center Fresno, California  93720
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O'Connor Hospital San Jose, California  95128
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David Grant Medical Center Travis Air Force Base, California  94535
Memorial Hospital Cancer Center Colorado Springs, Colorado  80909
University of Florida Health Science Center Gainesville, Florida  32610-0296
Health First Holmes Regional Medical Center Melbourne, Florida  32901
Baptist Hospital of Miami Miami, Florida  33176-2197
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St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
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Elliot Regional Cancer Center Manchester, New Hampshire  03103
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Newark Beth Israel Medical Center Newark, New Jersey  07112
Community Medical Center Toms River, New Jersey  08755
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Albert Einstein Cancer Center Philadelphia, Pennsylvania  19141
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Mercy Hospital of Pittsburgh Pittsburgh, Pennsylvania  15219
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Harrington Cancer Center Amarillo, Texas  79106
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Bayshore Medical Center Pasadena, Texas  77504
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Green Mountain Oncology Group Rutland, Vermont  05701
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Massey Cancer Center Richmond, Virginia  23298-0037
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St. Vincent Hospital Green Bay, Wisconsin  54307-3508
Gundersen Lutheran Medical Foundation La Crosse, Wisconsin  54601
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Southern Wisconsin Radiotherapy Center Madison, Wisconsin  53713
Community Memorial Hospital Menomonee Falls, Wisconsin  53051
Columbia Hospital Milwaukee, Wisconsin  53211
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Allegheny General Hospital Pittsburgh, Pennsylvania  15212-4772
Comprehensive Cancer Institute of Huntsville Huntsville, Alabama  35801
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St. Anthony Hospital Oklahoma City, Oklahoma  73101
St. John Health System Tulsa, Oklahoma  74104
University of Utah Health Sciences Center Salt Lake City, Utah  84132
Schiffler Cancer Center Wheeling, West Virginia  26003
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Cooper Cancer Institute Camden, New Jersey  08103
Capital Health System at Mercer Trenton, New Jersey  08607
Sutter Health West Cancer Research Group Greenbrae, California  94904
Huntington Cancer Center Pasadena, California  91105
Saint Mary's Hospital and Medical Center Grand Junction, Colorado  81502-1628
Regional Radiation Oncology Center at Rome Rome, Georgia  30165
Clarian Health Partners Inc. Indianapolis, Indiana  46206-1367
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William Beaumont Hospital - Troy Troy, Michigan  48098
Valley Hospital Ridgewood, New Jersey  07450
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Trinity Cancer Care Center Minot, North Dakota  58701
Mercy Fitzgerald Hospital Darby, Pennsylvania  19023
Pocono Cancer Center East Stroudsburg, Pennsylvania  18301
Latter Day Saints Hospital Salt Lake City, Utah  84143
RMH Regional Cancer Center Harrisonburg, Virginia  22801
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St. Joseph's Regional Health System Stockton, California  95204
Oncology Institute of Greater Lafayette Lafayette, Indiana  47904
Lourdes Regional Cancer Center Binghamton, New York  13905
North Shore Radiation Oncology Setauket, New York  11733
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Mayo Clinic Jacksonville, Florida  32224
Medcenter One Health System Bismarck, North Dakota  58501
Howard University Cancer Center Washington, District of Columbia  20060
Edna Williams Cancer Treatment Center Jacksonville, Florida  32207
Lexington Clinic Cancer Center Lexington, Kentucky  40504
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