- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003162
Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Center - Calgary
-
Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
-
-
New Brunswick
-
Saint John, New Brunswick, Canada, E2L 4L2
- Saint John Regional Hospital
-
-
Newfoundland and Labrador
-
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
- Newfoundland Cancer Treatment and Research Foundation
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Cancer Centre
-
-
Ontario
-
Hamilton, Ontario, Canada, L8V 5C2
- Cancer Care Ontario-Hamilton Regional Cancer Centre
-
Kingston, Ontario, Canada, K7L 5P9
- Kingston Regional Cancer Centre
-
London, Ontario, Canada, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
-
Ottawa, Ontario, Canada, K1H 1C4
- Ottawa Regional Cancer Centre
-
Sudbury, Ontario, Canada, P3E 5J1
- Northeastern Ontario Regional Cancer Centre, Sudbury
-
Thunder Bay, Ontario, Canada, P7A 7T1
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
-
Toronto, Ontario, Canada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
-
Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
-
-
Quebec
-
Fleurimont, Quebec, Canada, J1H 5N4
- CHUS-Hopital Fleurimont
-
Montreal, Quebec, Canada, H2W 1S6
- McGill University
-
Montreal, Quebec, Canada, H2L-4M1
- Centre Hospitalier de l'Universite de Montreal
-
Quebec City, Quebec, Canada, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
-
Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
-
Huntsville, Alabama, United States, 35801
- Comprehensive Cancer Institute of Huntsville
-
Huntsville, Alabama, United States, 35801-4470
- Huntsville Hospital System
-
Mobile, Alabama, United States, 36688
- MBCCOP - Gulf Coast
-
Montgomery, Alabama, United States, 36106-2801
- Alabama Oncology, LLC
-
Tuscaloosa, Alabama, United States, 35401
- Radiation Oncology Associates of West Alabama
-
-
Arizona
-
Phoenix, Arizona, United States, 85013
- Foundation for Cancer Research and Education
-
Scottsdale, Arizona, United States, 85259-5404
- CCOP - Scottsdale Oncology Program
-
-
California
-
Concord, California, United States, 94524-4110
- Mount Diablo Medical Center
-
Duarte, California, United States, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
-
Fresno, California, United States, 93720
- California Cancer Center
-
Fresno, California, United States, 93720
- Saint Agnes Cancer Center
-
Greenbrae, California, United States, 94904
- Sutter Health West Cancer Research Group
-
Loma Linda, California, United States, 92354
- Loma Linda University Medical Center
-
Long Beach, California, United States, 90822
- Veterans Affairs Medical Center - Long Beach
-
Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
Los Angeles, California, United States, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
-
Oakland, California, United States, 94609-3305
- CCOP - Bay Area Tumor Institute
-
Pasadena, California, United States, 91105
- Huntington Cancer Center
-
Pomona, California, United States, 91767
- Cancer Care Center
-
Sacramento, California, United States, 95816
- Radiation Oncology Center - Sacramento
-
San Diego, California, United States, 92101-1492
- Radiation Medical Group, Inc.
-
San Francisco, California, United States, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
-
San Jose, California, United States, 95128
- O'Connor Hospital
-
Santa Rosa, California, United States, 95403
- CCOP - Santa Rosa Memorial Hospital
-
Stockton, California, United States, 95204
- St. Joseph's Regional Health System
-
Travis Air Force Base, California, United States, 94535
- David Grant Medical Center
-
-
Colorado
-
Colorado Springs, Colorado, United States, 80909
- Memorial Hospital Cancer Center
-
Denver, Colorado, United States, 80010
- University of Colorado Cancer Center
-
Grand Junction, Colorado, United States, 81502
- Saint Mary's Hospital and Medical Center
-
-
Delaware
-
Wilmington, Delaware, United States, 19899
- CCOP - Christiana Care Health Services
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20060
- Howard University Cancer Center
-
-
Florida
-
Gainesville, Florida, United States, 32610-0296
- University of Florida Health Science Center
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic
-
Jacksonville, Florida, United States, 32207
- Edna Williams Cancer Treatment Center
-
Melbourne, Florida, United States, 32901
- Health First Holmes Regional Medical Center
-
Miami, Florida, United States, 33136
- Sylvester Cancer Center, University of Miami
-
Miami, Florida, United States, 33176-2197
- Baptist Hospital of Miami
-
Miami, Florida, United States, 33125
- Veterans Affairs Medical Center - Miami
-
Miami Beach, Florida, United States, 33140
- CCOP - Mount Sinai Medical Center
-
Orlando, Florida, United States, 32806
- MD Anderson Cancer Center Orlando
-
Panama City, Florida, United States, 32405-4587
- Gulf Coast Cancer Treatment Center
-
Panama City, Florida, United States, 32401
- Bay Medical Center
-
Sarasota, Florida, United States, 34233
- Sarasota Radiation and Medical Oncology Center
-
Tallahassee, Florida, United States, 32308
- Tallahassee Memorial Healthcare
-
Tampa, Florida, United States, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University Hospital - Atlanta
-
Atlanta, Georgia, United States, 30342-1701
- CCOP - Atlanta Regional
-
Columbus, Georgia, United States, 31902
- Medical Center/John B. Amos Community Cancer Center
-
Rome, Georgia, United States, 30165
- Regional Radiation Oncology Center at Rome
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96813
- MBCCOP - Hawaii
-
-
Illinois
-
Arlington Heights, Illinois, United States, 60005
- Northwest Community Hospital
-
Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
-
Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
-
Harvey, Illinois, United States, 60426
- Ingalls Memorial Hospital
-
Maywood, Illinois, United States, 60153
- Loyola University Medical Center
-
Park Ridge, Illinois, United States, 60068
- Lutheran General Cancer Care Center
-
Peoria, Illinois, United States, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, United States, 61602
- CCOP - Illinois Oncology Research Association
-
Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
-
-
Indiana
-
Anderson, Indiana, United States, 46016
- St. John's Medical Center
-
Bloomington, Indiana, United States, 47402
- Bloomington Hospital
-
Indianapolis, Indiana, United States, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
-
Indianapolis, Indiana, United States, 46206-1367
- Clarian Health Partners Inc.
-
Indianapolis, Indiana, United States, 46219
- Regional Cancer Center
-
Lafayette, Indiana, United States, 47904
- Oncology Institute of Greater Lafayette
-
Muncie, Indiana, United States, 47303-3499
- Ball Memorial Hospital
-
South Bend, Indiana, United States, 46601
- CCOP - Northern Indiana CR Consortium
-
-
Iowa
-
Cedar Rapids, Iowa, United States, 52403-1206
- CCOP - Cedar Rapids Oncology Project
-
Des Moines, Iowa, United States, 50309-1016
- CCOP - Iowa Oncology Research Association
-
Dubuque, Iowa, United States, 52001
- Wendt Regional Cancer Center of Finley Hospital
-
Sioux City, Iowa, United States, 51101-1733
- Siouxland Hematology-Oncology
-
-
Kansas
-
Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
-
Lexington, Kentucky, United States, 40503
- Central Baptist Hospital
-
Lexington, Kentucky, United States, 40504
- Lexington Clinic Cancer Center
-
Louisville, Kentucky, United States, 40202
- James Graham Brown Cancer Center
-
Louisville, Kentucky, United States, 40215
- Louisville Radiation Oncology
-
Madisonville, Kentucky, United States, 42431
- Merle M. Mahr Cancer Center
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70809
- Mary Bird Perkins Cancer Center
-
New Orleans, Louisiana, United States, 70112
- Tulane University School of Medicine
-
New Orleans, Louisiana, United States, 70121
- CCOP - Ochsner
-
New Orleans, Louisiana, United States, 70112
- MBCCOP - LSU Health Sciences Center
-
-
Maine
-
Portland, Maine, United States, 04102
- Maine Medical Center
-
-
Maryland
-
Annapolis, Maryland, United States, 21401
- Anne Arundel Oncology Center
-
Baltimore, Maryland, United States, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
Baltimore, Maryland, United States, 21225
- Sinai Hospital of Baltimore
-
Baltimore, Maryland, United States, 21204
- Greater Baltimore Medical Center and Cancer Center
-
Baltimore, Maryland, United States, 21225
- Harbor Hospital Center
-
Salisbury, Maryland, United States, 21801
- Peninsula Regional Medical Center
-
-
Massachusetts
-
Hyannis, Massachusetts, United States, 02601
- Cape Cod Hospital
-
Jamaica Plain, Massachusetts, United States, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109-0752
- University of Michigan Comprehensive Cancer Center
-
Ann Arbor, Michigan, United States, 48106
- CCOP - Ann Arbor Regional
-
Detroit, Michigan, United States, 48202
- Henry Ford Hospital
-
Detroit, Michigan, United States, 48201-1379
- Barbara Ann Karmanos Cancer Institute
-
Flint, Michigan, United States, 48503
- Hurley Medical Center
-
Flint, Michigan, United States, 48432
- McLaren Regional Cancer Center
-
Kalamazoo, Michigan, United States, 49007-3731
- CCOP - Kalamazoo
-
Marquette, Michigan, United States, 49855
- Marquette General Hospital
-
Midland, Michigan, United States, 48670
- MidMichigan Medical Center - Midland
-
Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital
-
Troy, Michigan, United States, 48098
- William Beaumont Hospital - Troy
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
-
Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
-
-
Missouri
-
Columbia, Missouri, United States, 65203
- Ellis Fischel Cancer Center - Columbia
-
Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
-
Saint Louis, Missouri, United States, 63110-0250
- St. Louis University Health Sciences Center
-
Saint Louis, Missouri, United States, 63108
- Mallinckrodt Institute of Radiology
-
Springfield, Missouri, United States, 65807
- CCOP - Cancer Research for the Ozarks
-
Springfield, Missouri, United States, 65807
- Cancer Research for the Ozarks
-
-
Montana
-
Billings, Montana, United States, 59101
- CCOP - Montana Cancer Consortium
-
-
Nebraska
-
Omaha, Nebraska, United States, 68114
- Methodist Cancer Center - Omaha
-
Omaha, Nebraska, United States, 68106
- CCOP - Missouri Valley Cancer Consortium
-
Omaha, Nebraska, United States, 68198-7460
- Nebraska Health System
-
-
Nevada
-
Las Vegas, Nevada, United States, 89106
- CCOP - Southern Nevada Cancer Research Foundation
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center
-
Manchester, New Hampshire, United States, 03103
- Elliot Regional Cancer Center
-
-
New Jersey
-
Camden, New Jersey, United States, 08103
- Cooper Cancer Institute
-
East Orange, New Jersey, United States, 07018-1095
- Veterans Affairs Medical Center - East Orange
-
Edison, New Jersey, United States, 08818
- John F. Kennedy Medical Center
-
Elizabeth, New Jersey, United States, 07201
- Trinitas Hospital - Jersey Street Campus
-
Lakewood, New Jersey, United States, 08701
- Kimball Medical Center
-
Long Branch, New Jersey, United States, 07740-6395
- Monmouth Medical Center
-
Millville, New Jersey, United States, 08332
- South Jersey Regional Cancer Center
-
Mount Holly, New Jersey, United States, 08060
- Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
-
New Brunswick, New Jersey, United States, 08903
- Cancer Institute of New Jersey
-
Newark, New Jersey, United States, 07112
- Newark Beth Israel Medical Center
-
Pomona, New Jersey, United States, 08240
- Atlantic City Medical Center
-
Ridgewood, New Jersey, United States, 07450
- Valley Hospital
-
Toms River, New Jersey, United States, 08755
- Community Medical Center
-
Trenton, New Jersey, United States, 08629
- St. Francis Medical Center
-
Trenton, New Jersey, United States, 08607
- Capital Health System at Mercer
-
Warren, New Jersey, United States, 07059
- Associated Radiologists, P.A.
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87109
- Radiation Oncology Associates of Albuquerque
-
-
New York
-
Albany, New York, United States, 12208
- Cancer Center of Albany Medical Center
-
Binghamton, New York, United States, 13905
- Lourdes Regional Cancer Center
-
Brooklyn, New York, United States, 11203
- State University of New York Health Science Center at Brooklyn
-
Brooklyn, New York, United States, 11215-3609
- New York Methodist Hospital
-
Clifton Springs, New York, United States, 14432
- Finger Lakes Radiation Oncology Center
-
Manhasset, New York, United States, 11030
- CCOP - North Shore University Hospital
-
New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center
-
Plattsburgh, New York, United States, 12901
- Champlain Valley Physicians Hospital Medical Center
-
Poughkeepsie, New York, United States, 12601
- Vassar Brothers Hospital
-
Rochester, New York, United States, 14642
- University of Rochester Cancer Center
-
Setauket, New York, United States, 11733
- North Shore Radiation Oncology
-
Syracuse, New York, United States, 13210
- State University of New York - Upstate Medical University
-
Syracuse, New York, United States, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
-
Yonkers, New York, United States, 10701
- Riverhill Radiation Oncology
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
-
Concord, North Carolina, United States, 28025
- Northeast Medical Center
-
Greenville, North Carolina, United States, 27858-4354
- East Carolina University School of Medicine
-
Raleigh, North Carolina, United States, 27607
- Rex Healthcare
-
Winston-Salem, North Carolina, United States, 27104-4241
- CCOP - Southeast Cancer Control Consortium
-
Winston-Salem, North Carolina, United States, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
-
-
North Dakota
-
Bismarck, North Dakota, United States, 58501
- Medcenter One Health System
-
Minot, North Dakota, United States, 58701
- Trinity Cancer Care Center
-
-
Ohio
-
Akron, Ohio, United States, 44302
- Akron General Medical Center
-
Akron, Ohio, United States, 44309
- Akron City Hospital
-
Cincinnati, Ohio, United States, 45219
- Christ Hospital
-
Cincinnati, Ohio, United States, 45267-0502
- Barrett Cancer Center, The University Hospital
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland, Ohio, United States, 44106
- University Hospitals of Cleveland
-
Cleveland, Ohio, United States, 44106-5065
- Ireland Cancer Center
-
Cleveland, Ohio, United States, 44195-5044
- Cleveland Clinic Foundation
-
Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
-
Columbus, Ohio, United States, 43206
- CCOP - Columbus
-
Kettering, Ohio, United States, 45429
- CCOP - Dayton
-
Toledo, Ohio, United States, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73190
- University of Oklahoma Health Sciences Center
-
Oklahoma City, Oklahoma, United States, 73101
- St. Anthony Hospital
-
Tulsa, Oklahoma, United States, 74104
- St. John Health System
-
-
Oregon
-
Portland, Oregon, United States, 97213
- CCOP - Columbia River Program
-
-
Pennsylvania
-
Allentown, Pennsylvania, United States, 18103
- LeHigh Valley Hospital
-
Bethlehem, Pennsylvania, United States, 18015
- St. Luke's Hospital Regional Cancer Center
-
Danville, Pennsylvania, United States, 17822-2001
- Geisinger Medical Center
-
Darby, Pennsylvania, United States, 19023
- Mercy Fitzgerald Hospital
-
Drexel Hill, Pennsylvania, United States, 19026
- Delaware County Memorial Hospital
-
East Stroudsburg, Pennsylvania, United States, 18301
- Pocono Cancer Center
-
Hershey, Pennsylvania, United States, 17033-0850
- Milton S. Hershey Medical Center
-
Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, United States, 19104
- Veterans Affairs Medical Center - Philadelphia
-
Philadelphia, Pennsylvania, United States, 19141
- Albert Einstein Cancer Center
-
Philadelphia, Pennsylvania, United States, 19104-4283
- University of Pennsylvania Cancer Center
-
Philadelphia, Pennsylvania, United States, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
-
Pittsburgh, Pennsylvania, United States, 15224
- Western Pennsylvania Hospital
-
Pittsburgh, Pennsylvania, United States, 15213-3489
- University of Pittsburgh Cancer Institute
-
Pittsburgh, Pennsylvania, United States, 15219
- Mercy Hospital of Pittsburgh
-
Pittsburgh, Pennsylvania, United States, 15212-4772
- Allegheny General Hospital
-
Reading, Pennsylvania, United States, 19612-6052
- Reading Hospital and Medical Center
-
Scranton, Pennsylvania, United States, 18501
- Mercy Hospital Cancer Center - Scranton
-
Wilkes-Barre, Pennsylvania, United States, 18764
- Wilkes Barre General Hospital
-
York, Pennsylvania, United States, 17315
- York Hospital
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02908-4735
- Roger Williams Medical Center/BUSM
-
-
South Carolina
-
Greenville, South Carolina, United States, 29615
- CCOP - Greenville
-
Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
-
-
South Dakota
-
Rapid City, South Dakota, United States, 57709
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, United States, 57104
- CCOP - Sioux Community Cancer Consortium
-
-
Tennessee
-
Jackson, Tennessee, United States, 38301
- Jackson-Madison County General Hospital
-
Memphis, Tennessee, United States, 38103
- University of Tennessee, Memphis Cancer Center
-
Nashville, Tennessee, United States, 37232-6838
- Vanderbilt-Ingram Cancer Center
-
-
Texas
-
Amarillo, Texas, United States, 79106
- Harrington Cancer Center
-
Galveston, Texas, United States, 77555-0209
- University of Texas Medical Branch
-
Houston, Texas, United States, 77030-4009
- University of Texas - MD Anderson Cancer Center
-
Lackland Air Force Base, Texas, United States, 78236-5300
- Wilford Hall - 59th Medical Wing
-
Lubbock, Texas, United States, 79410-1894
- Joe Arrington Cancer Research and Treatment Center
-
Pasadena, Texas, United States, 77504
- Bayshore Medical Center
-
-
Utah
-
Saint George, Utah, United States, 84770
- Dixie Regional Medical Center
-
Salt Lake City, Utah, United States, 84132
- University of Utah Health Sciences Center
-
Salt Lake City, Utah, United States, 84143
- Latter Day Saints Hospital
-
-
Vermont
-
Bennington, Vermont, United States, 05201
- Green Mountain Oncology Group
-
Burlington, Vermont, United States, 05401-3498
- Vermont Cancer Center
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- Cancer Center at the University of Virginia
-
Harrisonburg, Virginia, United States, 22801
- RMH Regional Cancer Center
-
Portsmouth, Virginia, United States, 23708-2197
- Naval Medical Center, Portsmouth
-
Richmond, Virginia, United States, 23298-0037
- Massey Cancer Center
-
Richmond, Virginia, United States, 23226
- Bon-Secours - St. Mary's Hospital
-
-
Washington
-
Seattle, Washington, United States, 98111
- Virginia Mason Medical Center
-
Spokane, Washington, United States, 99210-0248
- Deaconess Medical Center
-
Yakima, Washington, United States, 98902
- Yakima Valley Memorial Hospital
-
-
West Virginia
-
Wheeling, West Virginia, United States, 26003
- Schiffler Cancer Center
-
-
Wisconsin
-
Green Bay, Wisconsin, United States, 54307-3508
- St. Vincent Hospital
-
Green Bay, Wisconsin, United States, 54301
- CCOP - Green Bay
-
La Crosse, Wisconsin, United States, 54601
- Gundersen Lutheran Medical Foundation
-
Madison, Wisconsin, United States, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
-
Madison, Wisconsin, United States, 53713
- Southern Wisconsin Radiotherapy Center
-
Marshfield, Wisconsin, United States, 54449
- Marshfield Clinic
-
Menomonee Falls, Wisconsin, United States, 53051
- Community Memorial Hospital
-
Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
-
Milwaukee, Wisconsin, United States, 53211
- Columbia Hospital
-
Milwaukee, Wisconsin, United States, 53215
- St. Luke's Medical Center
-
Racine, Wisconsin, United States, 53405
- All Saints Cancer Center
-
Waukesha, Wisconsin, United States, 53188
- Waukesha Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional 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
3.0 Gy x 10 fractions for a total dose of 30.0 Gy in two weeks
|
|
Experimental: 8.0 Gy x 1 fraction
8.0 Gy x 1 fraction for a total dose of 8.0 Gy in a single dose
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: William F. Hartsell, MD, Advocate Lutheran General Hospital
- Study Chair: Ivy A. Petersen, MD, Mayo Clinic
Publications and helpful links
General Publications
- Bruner DW. Outcomes research in cancer symptom management trials: the Radiation Therapy Oncology Group (RTOG) conceptual model. J Natl Cancer Inst Monogr. 2007;(37):12-5. doi: 10.1093/jncimonographs/lgm004.
- Konski A, James J, Hartsell W, Leibenhaut MH, Janjan N, Curran W, Roach M, Watkins-Bruner D. Economic analysis of radiation therapy oncology group 97-14: multiple versus single fraction radiation treatment of patients with bone metastases. Am J Clin Oncol. 2009 Aug;32(4):423-8. doi: 10.1097/COC.0b013e31818da9f7.
- Juliano JJ, Reddy CA, Videtic GMM: How fast does practice change? A single-institution experience in utilization of a single fraction for palliation of bone metastases before and after RTOG 9714. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2561, S521-2, 2006.
- Chow E, James J, Barsevick A, Hartsell W, Ratcliffe S, Scarantino C, Ivker R, Roach M, Suh J, Petersen I, Konski A, Demas W, Bruner D. Functional interference clusters in cancer patients with bone metastases: a secondary analysis of RTOG 9714. Int J Radiat Oncol Biol Phys. 2010 Apr;76(5):1507-11. doi: 10.1016/j.ijrobp.2009.04.024. Epub 2009 Jul 23.
- Howell DD, James JL, Hartsell WF, et al.: Randomized trial of short-course versus long-course radiotherapy for palliation of painful vertebral bone metastases: A retrospective analysis of RTOG 97-14. [Abstract] J Clin Oncol 27 (Suppl 15): A-9521, 2009.
- Hartsell WF, Desilvio M, Bruner DW, Scarantino C, Ivker R, Roach M 3rd, Suh J, Demas WF, Movsas B, Petersen IA, Konski AA. Can physicians accurately predict survival time in patients with metastatic cancer? Analysis of RTOG 97-14. J Palliat Med. 2008 Jun;11(5):723-8. doi: 10.1089/jpm.2007.0259.
- Konski A, Desilvio M, Hartsell W, Watkins-Bruner D, Coyne J, Scarantino C, Janjan N. Continuing evidence for poorer treatment outcomes for single male patients: retreatment data from RTOG 97-14. Int J Radiat Oncol Biol Phys. 2006 Sep 1;66(1):229-33. doi: 10.1016/j.ijrobp.2006.04.005. Epub 2006 Jul 11.
- Hartsell WF, Scott CB, Bruner DW, Scarantino CW, Ivker RA, Roach M 3rd, Suh JH, Demas WF, Movsas B, Petersen IA, Konski AA, Cleeland CS, Janjan NA, DeSilvio M. Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases. J Natl Cancer Inst. 2005 Jun 1;97(11):798-804. doi: 10.1093/jnci/dji139.
- Hartsell WF, Winter K, Bruner DW, et al.: Breast cancer patients have better outcomes than prostate cancer patients for palliation of painful bone metastases: results of RTOG 97-14. [Abstract] J Clin Oncol 23 (Suppl 16): A-6073, 546s, 2005.
- Bruner DW, Winter K, Hartsell W, et al.: Prospective health-related quality of life valuations (utilities) of 8 Gy in 1 fraction vs 30 Gy in 10 fractions for palliation of painful bone metastases: preliminary results of RTOG 97-14. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-23, S142, 2004.
- Hartsell WF, Scott C, Bruner DW, et al.: Phase III randomized trial of 8 Gy in 1 fraction vs. 30 Gy in 10 fractions for palliation of painful bone metastases: preliminary results of RTOG 97-14. [Abstract] Int J Radiat Oncol Biol Phys 57 (2 Suppl): S124, 2003.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RTOG-9714
- CDR0000065957
- NCCTG-R9714
- NCI-P97-0124
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on radiation therapy
-
NRG OncologyNational Cancer Institute (NCI)RecruitingUnrectable or Locally Recurrent Hepatocellular CarcinomaUnited States
-
University of California, San FranciscoVarian Medical SystemsRecruitingStage IV Anal Cancer AJCC v8 | Metastatic Gastroesophageal Junction Adenocarcinoma | Metastatic Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Postneoadjuvant Therapy Stage... and other conditionsUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedBrain Tumor | Central Nervous System TumorUnited States, Canada, Australia, Puerto Rico, Switzerland, New Zealand
-
Medical College of WisconsinRecruitingHead and Neck CancerUnited States
-
Medical College of WisconsinRecruitingResectable Head and Neck Squamous Cell CarcinomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Completed
-
Changhai HospitalRecruitingLocalized Prostate CancerChina
-
NYU Langone HealthCompletedBreast CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAnn Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Extranodal Marginal Zone LymphomaUnited States
-
Medical College of WisconsinActive, not recruitingHigh-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB) (SIB)Prostate CancerUnited States