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Completed

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

ClinicalTrials.gov ID NCT00003162
Sponsor Radiation Therapy Oncology Group
Information provided by Radiation Therapy Oncology Group (Responsible Party)
Last Update Posted 2015-11-17
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Study Overview

Brief Summary

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.

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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.

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Official Title
Randomized Trial of Palliative Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life
Conditions
Breast Cancer
Metastatic Cancer
Pain
Prostate Cancer
Intervention / Treatment
  • Procedure: pain therapy
  • Radiation: radiation therapy
  • Procedure: pain therapy
  • Radiation: radiation therapy
Other Study ID Numbers
Study Start
1998-02
Primary Completion (Actual)
2003-07
Enrollment (Actual)
949
Study Type
Interventional
Phase
Phase 3

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 253 locations
United States
Alabama Locations
Birmingham, Alabama, United States, 35294-3300

University of Alabama at Birmingham Comprehensive Cancer Center
Huntsville, Alabama, United States, 35801-4470

Huntsville Hospital System
Huntsville, Alabama, United States, 35801

Comprehensive Cancer Institute of Huntsville
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 Locations
Phoenix, Arizona, United States, 85013

Foundation for Cancer Research and Education
Scottsdale, Arizona, United States, 85259-5404

CCOP - Scottsdale Oncology Program
California Locations
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, 90033-0804

USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90095-1781

Jonsson Comprehensive Cancer Center, UCLA
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 Locations
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 Locations
Wilmington, Delaware, United States, 19899

CCOP - Christiana Care Health Services
District of Columbia Locations
Washington, District of Columbia, United States, 20060

Howard University Cancer Center
Florida Locations
Gainesville, Florida, United States, 32610-0296

University of Florida Health Science Center
Jacksonville, Florida, United States, 32207

Edna Williams Cancer Treatment Center
Jacksonville, Florida, United States, 32224

Mayo Clinic
Melbourne, Florida, United States, 32901

Health First Holmes Regional Medical Center
Miami Beach, Florida, United States, 33140

CCOP - Mount Sinai Medical Center
Miami, Florida, United States, 33125

Veterans Affairs Medical Center - Miami
Miami, Florida, United States, 33136

Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33176-2197

Baptist Hospital of Miami
Orlando, Florida, United States, 32806

MD Anderson Cancer Center Orlando
Panama City, Florida, United States, 32401

Bay Medical Center
Panama City, Florida, United States, 32405-4587

Gulf Coast Cancer Treatment 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 Locations
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 Locations
Honolulu, Hawaii, United States, 96813

MBCCOP - Hawaii
Illinois Locations
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, 61602

CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61636

Methodist Medical Center of Illinois
Urbana, Illinois, United States, 61801

CCOP - Carle Cancer Center
Indiana Locations
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 Locations
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 Locations
Wichita, Kansas, United States, 67214-3882

CCOP - Wichita
Kentucky Locations
Lexington, Kentucky, United States, 40503

Central Baptist Hospital
Lexington, Kentucky, United States, 40504

Lexington Clinic Cancer Center
Lexington, Kentucky, United States, 40536-0084

Albert B. Chandler Medical Center, University of Kentucky
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 Locations
Baton Rouge, Louisiana, United States, 70809

Mary Bird Perkins Cancer Center
New Orleans, Louisiana, United States, 70112

MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112

Tulane University School of Medicine
New Orleans, Louisiana, United States, 70121

CCOP - Ochsner
Maine Locations
Portland, Maine, United States, 04102

Maine Medical Center
Maryland Locations
Annapolis, Maryland, United States, 21401

Anne Arundel Oncology Center
Baltimore, Maryland, United States, 21204

Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States, 21225

Harbor Hospital Center
Baltimore, Maryland, United States, 21225

Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21231-2410

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Salisbury, Maryland, United States, 21801

Peninsula Regional Medical Center
Massachusetts Locations
Hyannis, Massachusetts, United States, 02601

Cape Cod Hospital
Jamaica Plain, Massachusetts, United States, 02130

Veterans Affairs Medical Center - Boston (Jamaica Plain)
Michigan Locations
Ann Arbor, Michigan, United States, 48106

CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48109-0752

University of Michigan Comprehensive Cancer Center
Detroit, Michigan, United States, 48201-1379

Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48202

Henry Ford Hospital
Flint, Michigan, United States, 48432

McLaren Regional Cancer Center
Flint, Michigan, United States, 48503

Hurley Medical 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 Locations
Rochester, Minnesota, United States, 55905

Mayo Clinic Cancer Center
Saint Louis Park, Minnesota, United States, 55416

CCOP - Metro-Minnesota
Missouri Locations
Columbia, Missouri, United States, 65203

Ellis Fischel Cancer Center - Columbia
Kansas City, Missouri, United States, 64131

CCOP - Kansas City
Saint Louis, Missouri, United States, 63108

Mallinckrodt Institute of Radiology
Saint Louis, Missouri, United States, 63110-0250

St. Louis University Health Sciences Center
Springfield, Missouri, United States, 65807

Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807

CCOP - Cancer Research for the Ozarks
Montana Locations
Billings, Montana, United States, 59101

CCOP - Montana Cancer Consortium
Nebraska Locations
Omaha, Nebraska, United States, 68106

CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68114

Methodist Cancer Center - Omaha
Omaha, Nebraska, United States, 68198-7460

Nebraska Health System
Nevada Locations
Las Vegas, Nevada, United States, 89106

CCOP - Southern Nevada Cancer Research Foundation
New Hampshire Locations
Lebanon, New Hampshire, United States, 03756-0002

Norris Cotton Cancer Center
Manchester, New Hampshire, United States, 03103

Elliot Regional Cancer Center
New Jersey Locations
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, 08607

Capital Health System at Mercer
Trenton, New Jersey, United States, 08629

St. Francis Medical Center
Warren, New Jersey, United States, 07059

Associated Radiologists, P.A.
New Mexico Locations
Albuquerque, New Mexico, United States, 87109

Radiation Oncology Associates of Albuquerque
New York Locations
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 Locations
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 Locations
Bismarck, North Dakota, United States, 58501

Medcenter One Health System
Minot, North Dakota, United States, 58701

Trinity Cancer Care Center
Ohio Locations
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, 44106-5065

Ireland Cancer Center
Cleveland, Ohio, United States, 44106

University Hospitals of Cleveland
Cleveland, Ohio, United States, 44195-5044

Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195

Cleveland Clinic Taussig Cancer Center
Columbus, Ohio, United States, 43206

CCOP - Columbus
Columbus, Ohio, United States, 43210-1240

Arthur G. James Cancer Hospital - Ohio State University
Kettering, Ohio, United States, 45429

CCOP - Dayton
Toledo, Ohio, United States, 43623-3456

CCOP - Toledo Community Hospital Oncology Program
Oklahoma Locations
Oklahoma City, Oklahoma, United States, 73101

St. Anthony Hospital
Oklahoma City, Oklahoma, United States, 73190

University of Oklahoma Health Sciences Center
Tulsa, Oklahoma, United States, 74104

St. John Health System
Oregon Locations
Portland, Oregon, United States, 97213

CCOP - Columbia River Program
Pennsylvania Locations
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, 19104-4283

University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104

Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19111

Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19141

Albert Einstein Cancer Center
Pittsburgh, Pennsylvania, United States, 15212-4772

Allegheny General 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, 15224

Western Pennsylvania 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 Locations
Providence, Rhode Island, United States, 02908-4735

Roger Williams Medical Center/BUSM
South Carolina Locations
Greenville, South Carolina, United States, 29615

CCOP - Greenville
Spartanburg, South Carolina, United States, 29303

CCOP - Upstate Carolina
South Dakota Locations
Rapid City, South Dakota, United States, 57709

Rapid City Regional Hospital
Sioux Falls, South Dakota, United States, 57104

CCOP - Sioux Community Cancer Consortium
Tennessee Locations
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 Locations
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 Locations
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 Locations
Bennington, Vermont, United States, 05201

Green Mountain Oncology Group
Burlington, Vermont, United States, 05401-3498

Vermont Cancer Center
Virginia Locations
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, 23226

Bon-Secours - St. Mary's Hospital
Richmond, Virginia, United States, 23298-0037

Massey Cancer Center
Washington Locations
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 Locations
Wheeling, West Virginia, United States, 26003

Schiffler Cancer Center
Wisconsin Locations
Green Bay, Wisconsin, United States, 54301

CCOP - Green Bay
Green Bay, Wisconsin, United States, 54307-3508

St. Vincent Hospital
La Crosse, Wisconsin, United States, 54601

Gundersen Lutheran Medical Foundation
Madison, Wisconsin, United States, 53713

Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, United States, 53792-6164

University of Wisconsin Comprehensive Cancer Center
Marshfield, Wisconsin, United States, 54449

Marshfield Clinic
Menomonee Falls, Wisconsin, United States, 53051

Community Memorial Hospital
Milwaukee, Wisconsin, United States, 53211

Columbia Hospital
Milwaukee, Wisconsin, United States, 53215

St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53226

Medical College of Wisconsin
Racine, Wisconsin, United States, 53405

All Saints Cancer Center
Waukesha, Wisconsin, United States, 53188

Waukesha Memorial Hospital
Canada
Alberta Locations
Calgary, Alberta, Canada, T2N 4N2

Tom Baker Cancer Center - Calgary
Edmonton, Alberta, Canada, T6G 1Z2

Cross Cancer Institute
New Brunswick Locations
Saint John, New Brunswick, Canada, E2L 4L2

Saint John Regional Hospital
Newfoundland and Labrador Locations
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6

Newfoundland Cancer Treatment and Research Foundation
Nova Scotia Locations
Halifax, Nova Scotia, Canada, B3H 1V7

Nova Scotia Cancer Centre
Ontario Locations
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 Locations
Fleurimont, Quebec, Canada, J1H 5N4

CHUS-Hopital Fleurimont
Montreal, Quebec, Canada, H2L-4M1

Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2W 1S6

McGill University
Quebec City, Quebec, Canada, G1R 2J6

Centre Hospitalier Universitaire de Quebec
Saskatchewan Locations
Regina, Saskatchewan, Canada, S4T 7T1

Allan Blair Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4

Saskatoon Cancer Centre
Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
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
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Ages Eligible for Study
18 Years and older (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm 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
Intervention/Treatment Procedure: pain therapy
Radiation: radiation therapy
Participant Group/Arm 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
Intervention/Treatment Procedure: pain therapy
Radiation: radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Radiation Therapy Oncology Group
Collaborators
  • National Cancer Institute (NCI)
  • North Central Cancer Treatment Group
Investigators
  • Study Chair:William F. Hartsell, MD,Advocate Lutheran General Hospital
  • Study Chair:Ivy A. Petersen, MD,Mayo Clinic

Publications

General

These publications are provided voluntarily by the person who enters information about the study and may be about anything related to the study.

Study Results

These publications are provided voluntarily by the person who enters information about the study and are about the study results.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
1999-11-01
First Submitted that Met QC Criteria
2003-04-17
First Posted (Estimated)
2003-04-18
Study Record Updates
Last Update Submitted that met QC Criteria
2015-11-14
Last Update Posted (Estimated)
2015-11-17
Last Verified
2015-11

More Information

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Keywords Provided by Radiation Therapy Oncology Group
Additional Relevant MeSH Terms