- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00003162
Stråleterapi til behandling af patienter med knoglemetastaser fra bryst- eller prostatakræft
Randomiseret forsøg med palliativ strålebehandling for ossøse metastaser: En undersøgelse af lindring af symptomer og livskvalitet
RATIONALE: Strålebehandling bruger højenergi-røntgenstråler til at beskadige tumorceller. Det vides endnu ikke, hvilket strålebehandlingsregime der er mere effektivt til knoglemetastaser.
FORMÅL: Randomiseret fase III-forsøg til at sammenligne forskellige strålebehandlingsregimer til behandling af patienter, der har knoglemetastaser fra bryst- eller prostatacancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
MÅL:
- Sammenlign evnen af en enkelt fraktion af strålebehandling versus flere fraktioner til at give fuldstændig smertelindring hos patienter med smertefulde knoglemetastaser fra bryst- eller prostatacancer.
- Bestem hyppigheden og varigheden af smertelindring og narkotisk lindring efter disse behandlinger i disse patientpopulationer.
- Sammenlign effekten på livskvaliteten af disse to behandlinger i disse patientpopulationer.
- Sammenlign forekomsten af patologisk fraktur inden for behandlingsfelterne efter disse to behandlinger i disse patientpopulationer.
OVERSIGT: Dette er en randomiseret undersøgelse.
Patienterne tildeles 1 af 2 behandlingsarme. Arm I består af strålebehandling afgivet i 10 fraktioner over 2 uger. Arm II består af en enkelt dosis strålebehandling. Enhver genbehandling finder ikke sted før mindst 4 uger efter forudgående behandling, medmindre der er en stigning på 2 point på smertescore.
Patienterne følges og livskvalitet vurderes efter 2 og 4 uger, derefter efter 2, 3, 6, 9 og 12 måneder, hver 6. måned i de næste 3 år, derefter årligt indtil døden.
PROJEKTERET TILSLUTNING: Denne undersøgelse vil akkumulere 938 patienter inden for 2 år.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Center - Calgary
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
-
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New Brunswick
-
Saint John, New Brunswick, Canada, E2L 4L2
- Saint John Regional Hospital
-
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Newfoundland and Labrador
-
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
- Newfoundland Cancer Treatment and Research Foundation
-
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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
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Kingston, Ontario, Canada, K7L 5P9
- Kingston Regional Cancer Centre
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London, Ontario, Canada, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Ottawa, Ontario, Canada, K1H 1C4
- Ottawa Regional Cancer Centre
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Sudbury, Ontario, Canada, P3E 5J1
- Northeastern Ontario Regional Cancer Centre, Sudbury
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Thunder Bay, Ontario, Canada, P7A 7T1
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
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Toronto, Ontario, Canada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
-
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Quebec
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Fleurimont, Quebec, Canada, J1H 5N4
- CHUS-Hopital Fleurimont
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Montreal, Quebec, Canada, H2W 1S6
- McGill University
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Montreal, Quebec, Canada, H2L-4M1
- Centre Hospitalier de l'Universite de Montreal
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Quebec City, Quebec, Canada, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
-
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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-
-
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Huntsville, Alabama, Forenede Stater, 35801
- Comprehensive Cancer Institute of Huntsville
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Huntsville, Alabama, Forenede Stater, 35801-4470
- Huntsville Hospital System
-
Mobile, Alabama, Forenede Stater, 36688
- MBCCOP - Gulf Coast
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Montgomery, Alabama, Forenede Stater, 36106-2801
- Alabama Oncology, LLC
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Tuscaloosa, Alabama, Forenede Stater, 35401
- Radiation Oncology Associates of West Alabama
-
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Arizona
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Phoenix, Arizona, Forenede Stater, 85013
- Foundation for Cancer Research and Education
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Scottsdale, Arizona, Forenede Stater, 85259-5404
- CCOP - Scottsdale Oncology Program
-
-
California
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Concord, California, Forenede Stater, 94524-4110
- Mount Diablo Medical Center
-
Duarte, California, Forenede Stater, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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Fresno, California, Forenede Stater, 93720
- California Cancer Center
-
Fresno, California, Forenede Stater, 93720
- Saint Agnes Cancer Center
-
Greenbrae, California, Forenede Stater, 94904
- Sutter Health West Cancer Research Group
-
Loma Linda, California, Forenede Stater, 92354
- Loma Linda University Medical Center
-
Long Beach, California, Forenede Stater, 90822
- Veterans Affairs Medical Center - Long Beach
-
Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
Los Angeles, California, Forenede Stater, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
-
Oakland, California, Forenede Stater, 94609-3305
- CCOP - Bay Area Tumor Institute
-
Pasadena, California, Forenede Stater, 91105
- Huntington Cancer Center
-
Pomona, California, Forenede Stater, 91767
- Cancer Care Center
-
Sacramento, California, Forenede Stater, 95816
- Radiation Oncology Center - Sacramento
-
San Diego, California, Forenede Stater, 92101-1492
- Radiation Medical Group, Inc.
-
San Francisco, California, Forenede Stater, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
-
San Jose, California, Forenede Stater, 95128
- O'Connor Hospital
-
Santa Rosa, California, Forenede Stater, 95403
- CCOP - Santa Rosa Memorial Hospital
-
Stockton, California, Forenede Stater, 95204
- St. Joseph's Regional Health System
-
Travis Air Force Base, California, Forenede Stater, 94535
- David Grant Medical Center
-
-
Colorado
-
Colorado Springs, Colorado, Forenede Stater, 80909
- Memorial Hospital Cancer Center
-
Denver, Colorado, Forenede Stater, 80010
- University of Colorado Cancer Center
-
Grand Junction, Colorado, Forenede Stater, 81502
- Saint Mary's Hospital and Medical Center
-
-
Delaware
-
Wilmington, Delaware, Forenede Stater, 19899
- CCOP - Christiana Care Health Services
-
-
District of Columbia
-
Washington, District of Columbia, Forenede Stater, 20060
- Howard University Cancer Center
-
-
Florida
-
Gainesville, Florida, Forenede Stater, 32610-0296
- University of Florida Health Science Center
-
Jacksonville, Florida, Forenede Stater, 32224
- Mayo Clinic
-
Jacksonville, Florida, Forenede Stater, 32207
- Edna Williams Cancer Treatment Center
-
Melbourne, Florida, Forenede Stater, 32901
- Health First Holmes Regional Medical Center
-
Miami, Florida, Forenede Stater, 33136
- Sylvester Cancer Center, University of Miami
-
Miami, Florida, Forenede Stater, 33176-2197
- Baptist Hospital of Miami
-
Miami, Florida, Forenede Stater, 33125
- Veterans Affairs Medical Center - Miami
-
Miami Beach, Florida, Forenede Stater, 33140
- CCOP - Mount Sinai Medical Center
-
Orlando, Florida, Forenede Stater, 32806
- MD Anderson Cancer Center Orlando
-
Panama City, Florida, Forenede Stater, 32405-4587
- Gulf Coast Cancer Treatment Center
-
Panama City, Florida, Forenede Stater, 32401
- Bay Medical Center
-
Sarasota, Florida, Forenede Stater, 34233
- Sarasota Radiation and Medical Oncology Center
-
Tallahassee, Florida, Forenede Stater, 32308
- Tallahassee Memorial HealthCare
-
Tampa, Florida, Forenede Stater, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30322
- Emory University Hospital - Atlanta
-
Atlanta, Georgia, Forenede Stater, 30342-1701
- CCOP - Atlanta Regional
-
Columbus, Georgia, Forenede Stater, 31902
- Medical Center/John B. Amos Community Cancer Center
-
Rome, Georgia, Forenede Stater, 30165
- Regional Radiation Oncology Center at Rome
-
-
Hawaii
-
Honolulu, Hawaii, Forenede Stater, 96813
- MBCCOP - Hawaii
-
-
Illinois
-
Arlington Heights, Illinois, Forenede Stater, 60005
- Northwest Community Hospital
-
Chicago, Illinois, Forenede Stater, 60611
- Northwestern Memorial Hospital
-
Decatur, Illinois, Forenede Stater, 62526
- CCOP - Central Illinois
-
Harvey, Illinois, Forenede Stater, 60426
- Ingalls Memorial Hospital
-
Maywood, Illinois, Forenede Stater, 60153
- Loyola University Medical Center
-
Park Ridge, Illinois, Forenede Stater, 60068
- Lutheran General Cancer Care Center
-
Peoria, Illinois, Forenede Stater, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Forenede Stater, 61602
- CCOP - Illinois Oncology Research Association
-
Urbana, Illinois, Forenede Stater, 61801
- CCOP - Carle Cancer Center
-
-
Indiana
-
Anderson, Indiana, Forenede Stater, 46016
- St. John's Medical Center
-
Bloomington, Indiana, Forenede Stater, 47402
- Bloomington Hospital
-
Indianapolis, Indiana, Forenede Stater, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
-
Indianapolis, Indiana, Forenede Stater, 46206-1367
- Clarian Health Partners Inc.
-
Indianapolis, Indiana, Forenede Stater, 46219
- Regional Cancer Center
-
Lafayette, Indiana, Forenede Stater, 47904
- Oncology Institute of Greater Lafayette
-
Muncie, Indiana, Forenede Stater, 47303-3499
- Ball Memorial Hospital
-
South Bend, Indiana, Forenede Stater, 46601
- CCOP - Northern Indiana CR Consortium
-
-
Iowa
-
Cedar Rapids, Iowa, Forenede Stater, 52403-1206
- CCOP - Cedar Rapids Oncology Project
-
Des Moines, Iowa, Forenede Stater, 50309-1016
- CCOP - Iowa Oncology Research Association
-
Dubuque, Iowa, Forenede Stater, 52001
- Wendt Regional Cancer Center of Finley Hospital
-
Sioux City, Iowa, Forenede Stater, 51101-1733
- Siouxland Hematology-Oncology
-
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Kansas
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Wichita, Kansas, Forenede Stater, 67214-3882
- CCOP - Wichita
-
-
Kentucky
-
Lexington, Kentucky, Forenede Stater, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
-
Lexington, Kentucky, Forenede Stater, 40503
- Central Baptist Hospital
-
Lexington, Kentucky, Forenede Stater, 40504
- Lexington Clinic Cancer Center
-
Louisville, Kentucky, Forenede Stater, 40202
- James Graham Brown Cancer Center
-
Louisville, Kentucky, Forenede Stater, 40215
- Louisville Radiation Oncology
-
Madisonville, Kentucky, Forenede Stater, 42431
- Merle M. Mahr Cancer Center
-
-
Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809
- Mary Bird Perkins Cancer Center
-
New Orleans, Louisiana, Forenede Stater, 70112
- Tulane University School of Medicine
-
New Orleans, Louisiana, Forenede Stater, 70121
- CCOP - Ochsner
-
New Orleans, Louisiana, Forenede Stater, 70112
- MBCCOP - LSU Health Sciences Center
-
-
Maine
-
Portland, Maine, Forenede Stater, 04102
- Maine Medical Center
-
-
Maryland
-
Annapolis, Maryland, Forenede Stater, 21401
- Anne Arundel Oncology Center
-
Baltimore, Maryland, Forenede Stater, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
Baltimore, Maryland, Forenede Stater, 21225
- Sinai Hospital of Baltimore
-
Baltimore, Maryland, Forenede Stater, 21204
- Greater Baltimore Medical Center and Cancer Center
-
Baltimore, Maryland, Forenede Stater, 21225
- Harbor Hospital Center
-
Salisbury, Maryland, Forenede Stater, 21801
- Peninsula Regional Medical Center
-
-
Massachusetts
-
Hyannis, Massachusetts, Forenede Stater, 02601
- Cape Cod Hospital
-
Jamaica Plain, Massachusetts, Forenede Stater, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109-0752
- University of Michigan Comprehensive Cancer Center
-
Ann Arbor, Michigan, Forenede Stater, 48106
- CCOP - Ann Arbor Regional
-
Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
-
Detroit, Michigan, Forenede Stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
-
Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
-
Flint, Michigan, Forenede Stater, 48432
- McLaren Regional Cancer Center
-
Kalamazoo, Michigan, Forenede Stater, 49007-3731
- CCOP - Kalamazoo
-
Marquette, Michigan, Forenede Stater, 49855
- Marquette General Hospital
-
Midland, Michigan, Forenede Stater, 48670
- MidMichigan Medical Center - Midland
-
Royal Oak, Michigan, Forenede Stater, 48073
- William Beaumont Hospital
-
Troy, Michigan, Forenede Stater, 48098
- William Beaumont Hospital - Troy
-
-
Minnesota
-
Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
-
Saint Louis Park, Minnesota, Forenede Stater, 55416
- CCOP - Metro-Minnesota
-
-
Missouri
-
Columbia, Missouri, Forenede Stater, 65203
- Ellis Fischel Cancer Center - Columbia
-
Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
-
Saint Louis, Missouri, Forenede Stater, 63110-0250
- St. Louis University Health Sciences Center
-
Saint Louis, Missouri, Forenede Stater, 63108
- Mallinckrodt Institute of Radiology
-
Springfield, Missouri, Forenede Stater, 65807
- CCOP - Cancer Research for the Ozarks
-
Springfield, Missouri, Forenede Stater, 65807
- Cancer Research for the Ozarks
-
-
Montana
-
Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
-
-
Nebraska
-
Omaha, Nebraska, Forenede Stater, 68114
- Methodist Cancer Center - Omaha
-
Omaha, Nebraska, Forenede Stater, 68106
- CCOP - Missouri Valley Cancer Consortium
-
Omaha, Nebraska, Forenede Stater, 68198-7460
- Nebraska Health System
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89106
- CCOP - Southern Nevada Cancer Research Foundation
-
-
New Hampshire
-
Lebanon, New Hampshire, Forenede Stater, 03756-0002
- Norris Cotton Cancer Center
-
Manchester, New Hampshire, Forenede Stater, 03103
- Elliot Regional Cancer Center
-
-
New Jersey
-
Camden, New Jersey, Forenede Stater, 08103
- Cooper Cancer Institute
-
East Orange, New Jersey, Forenede Stater, 07018-1095
- Veterans Affairs Medical Center - East Orange
-
Edison, New Jersey, Forenede Stater, 08818
- John F. Kennedy Medical Center
-
Elizabeth, New Jersey, Forenede Stater, 07201
- Trinitas Hospital - Jersey Street Campus
-
Lakewood, New Jersey, Forenede Stater, 08701
- Kimball Medical Center
-
Long Branch, New Jersey, Forenede Stater, 07740-6395
- Monmouth Medical Center
-
Millville, New Jersey, Forenede Stater, 08332
- South Jersey Regional Cancer Center
-
Mount Holly, New Jersey, Forenede Stater, 08060
- Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
-
New Brunswick, New Jersey, Forenede Stater, 08903
- Cancer Institute of New Jersey
-
Newark, New Jersey, Forenede Stater, 07112
- Newark Beth Israel Medical Center
-
Pomona, New Jersey, Forenede Stater, 08240
- Atlantic City Medical Center
-
Ridgewood, New Jersey, Forenede Stater, 07450
- Valley Hospital
-
Toms River, New Jersey, Forenede Stater, 08755
- Community Medical Center
-
Trenton, New Jersey, Forenede Stater, 08629
- St. Francis Medical Center
-
Trenton, New Jersey, Forenede Stater, 08607
- Capital Health System at Mercer
-
Warren, New Jersey, Forenede Stater, 07059
- Associated Radiologists, P.A.
-
-
New Mexico
-
Albuquerque, New Mexico, Forenede Stater, 87109
- Radiation Oncology Associates of Albuquerque
-
-
New York
-
Albany, New York, Forenede Stater, 12208
- Cancer Center of Albany Medical Center
-
Binghamton, New York, Forenede Stater, 13905
- Lourdes Regional Cancer Center
-
Brooklyn, New York, Forenede Stater, 11203
- State University of New York Health Science Center at Brooklyn
-
Brooklyn, New York, Forenede Stater, 11215-3609
- New York Methodist Hospital
-
Clifton Springs, New York, Forenede Stater, 14432
- Finger Lakes Radiation Oncology Center
-
Manhasset, New York, Forenede Stater, 11030
- CCOP - North Shore University Hospital
-
New York, New York, Forenede Stater, 10021
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, Forenede Stater, 10032
- Herbert Irving Comprehensive Cancer Center
-
Plattsburgh, New York, Forenede Stater, 12901
- Champlain Valley Physicians Hospital Medical Center
-
Poughkeepsie, New York, Forenede Stater, 12601
- Vassar Brothers Hospital
-
Rochester, New York, Forenede Stater, 14642
- University of Rochester Cancer Center
-
Setauket, New York, Forenede Stater, 11733
- North Shore Radiation Oncology
-
Syracuse, New York, Forenede Stater, 13210
- State University of New York - Upstate Medical University
-
Syracuse, New York, Forenede Stater, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
-
Yonkers, New York, Forenede Stater, 10701
- Riverhill Radiation Oncology
-
-
North Carolina
-
Chapel Hill, North Carolina, Forenede Stater, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
-
Concord, North Carolina, Forenede Stater, 28025
- Northeast Medical Center
-
Greenville, North Carolina, Forenede Stater, 27858-4354
- East Carolina University School of Medicine
-
Raleigh, North Carolina, Forenede Stater, 27607
- Rex Healthcare
-
Winston-Salem, North Carolina, Forenede Stater, 27104-4241
- CCOP - Southeast Cancer Control Consortium
-
Winston-Salem, North Carolina, Forenede Stater, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
-
-
North Dakota
-
Bismarck, North Dakota, Forenede Stater, 58501
- Medcenter One Health System
-
Minot, North Dakota, Forenede Stater, 58701
- Trinity Cancer Care Center
-
-
Ohio
-
Akron, Ohio, Forenede Stater, 44302
- Akron General Medical Center
-
Akron, Ohio, Forenede Stater, 44309
- Akron City Hospital
-
Cincinnati, Ohio, Forenede Stater, 45219
- Christ Hospital
-
Cincinnati, Ohio, Forenede Stater, 45267-0502
- Barrett Cancer Center, The University Hospital
-
Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland, Ohio, Forenede Stater, 44106
- University Hospitals of Cleveland
-
Cleveland, Ohio, Forenede Stater, 44106-5065
- Ireland Cancer Center
-
Cleveland, Ohio, Forenede Stater, 44195-5044
- Cleveland Clinic Foundation
-
Columbus, Ohio, Forenede Stater, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
-
Columbus, Ohio, Forenede Stater, 43206
- CCOP - Columbus
-
Kettering, Ohio, Forenede Stater, 45429
- CCOP - Dayton
-
Toledo, Ohio, Forenede Stater, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater, 73190
- University of Oklahoma Health Sciences Center
-
Oklahoma City, Oklahoma, Forenede Stater, 73101
- St. Anthony Hospital
-
Tulsa, Oklahoma, Forenede Stater, 74104
- St. John Health System
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97213
- CCOP - Columbia River Program
-
-
Pennsylvania
-
Allentown, Pennsylvania, Forenede Stater, 18103
- LeHigh Valley Hospital
-
Bethlehem, Pennsylvania, Forenede Stater, 18015
- St. Luke's Hospital Regional Cancer Center
-
Danville, Pennsylvania, Forenede Stater, 17822-2001
- Geisinger Medical Center
-
Darby, Pennsylvania, Forenede Stater, 19023
- Mercy Fitzgerald Hospital
-
Drexel Hill, Pennsylvania, Forenede Stater, 19026
- Delaware County Memorial Hospital
-
East Stroudsburg, Pennsylvania, Forenede Stater, 18301
- Pocono Cancer Center
-
Hershey, Pennsylvania, Forenede Stater, 17033-0850
- Milton S. Hershey Medical Center
-
Philadelphia, Pennsylvania, Forenede Stater, 19111
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- Veterans Affairs Medical Center - Philadelphia
-
Philadelphia, Pennsylvania, Forenede Stater, 19141
- Albert Einstein Cancer Center
-
Philadelphia, Pennsylvania, Forenede Stater, 19104-4283
- University of Pennsylvania Cancer Center
-
Philadelphia, Pennsylvania, Forenede Stater, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
-
Pittsburgh, Pennsylvania, Forenede Stater, 15224
- Western Pennsylvania Hospital
-
Pittsburgh, Pennsylvania, Forenede Stater, 15213-3489
- University of Pittsburgh Cancer Institute
-
Pittsburgh, Pennsylvania, Forenede Stater, 15219
- Mercy Hospital of Pittsburgh
-
Pittsburgh, Pennsylvania, Forenede Stater, 15212-4772
- Allegheny General Hospital
-
Reading, Pennsylvania, Forenede Stater, 19612-6052
- Reading Hospital and Medical Center
-
Scranton, Pennsylvania, Forenede Stater, 18501
- Mercy Hospital Cancer Center - Scranton
-
Wilkes-Barre, Pennsylvania, Forenede Stater, 18764
- Wilkes Barre General Hospital
-
York, Pennsylvania, Forenede Stater, 17315
- York Hospital
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02908-4735
- Roger Williams Medical Center/BUSM
-
-
South Carolina
-
Greenville, South Carolina, Forenede Stater, 29615
- CCOP - Greenville
-
Spartanburg, South Carolina, Forenede Stater, 29303
- CCOP - Upstate Carolina
-
-
South Dakota
-
Rapid City, South Dakota, Forenede Stater, 57709
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Forenede Stater, 57104
- CCOP - Sioux Community Cancer Consortium
-
-
Tennessee
-
Jackson, Tennessee, Forenede Stater, 38301
- Jackson-Madison County General Hospital
-
Memphis, Tennessee, Forenede Stater, 38103
- University of Tennessee, Memphis Cancer Center
-
Nashville, Tennessee, Forenede Stater, 37232-6838
- Vanderbilt-Ingram Cancer Center
-
-
Texas
-
Amarillo, Texas, Forenede Stater, 79106
- Harrington Cancer Center
-
Galveston, Texas, Forenede Stater, 77555-0209
- University of Texas Medical Branch
-
Houston, Texas, Forenede Stater, 77030-4009
- University of Texas - MD Anderson Cancer Center
-
Lackland Air Force Base, Texas, Forenede Stater, 78236-5300
- Wilford Hall - 59th Medical Wing
-
Lubbock, Texas, Forenede Stater, 79410-1894
- Joe Arrington Cancer Research and Treatment Center
-
Pasadena, Texas, Forenede Stater, 77504
- Bayshore Medical Center
-
-
Utah
-
Saint George, Utah, Forenede Stater, 84770
- Dixie Regional Medical Center
-
Salt Lake City, Utah, Forenede Stater, 84132
- University of Utah Health Sciences Center
-
Salt Lake City, Utah, Forenede Stater, 84143
- Latter Day Saints Hospital
-
-
Vermont
-
Bennington, Vermont, Forenede Stater, 05201
- Green Mountain Oncology Group
-
Burlington, Vermont, Forenede Stater, 05401-3498
- Vermont Cancer Center
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22908
- Cancer Center at the University of Virginia
-
Harrisonburg, Virginia, Forenede Stater, 22801
- RMH Regional Cancer Center
-
Portsmouth, Virginia, Forenede Stater, 23708-2197
- Naval Medical Center, Portsmouth
-
Richmond, Virginia, Forenede Stater, 23298-0037
- Massey Cancer Center
-
Richmond, Virginia, Forenede Stater, 23226
- Bon-Secours - St. Mary's Hospital
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98111
- Virginia Mason Medical Center
-
Spokane, Washington, Forenede Stater, 99210-0248
- Deaconess Medical Center
-
Yakima, Washington, Forenede Stater, 98902
- Yakima Valley Memorial Hospital
-
-
West Virginia
-
Wheeling, West Virginia, Forenede Stater, 26003
- Schiffler Cancer Center
-
-
Wisconsin
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Green Bay, Wisconsin, Forenede Stater, 54307-3508
- St. Vincent Hospital
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Green Bay, Wisconsin, Forenede Stater, 54301
- CCOP - Green Bay
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La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Medical Foundation
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Madison, Wisconsin, Forenede Stater, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Madison, Wisconsin, Forenede Stater, 53713
- Southern Wisconsin Radiotherapy Center
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Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Clinic
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Menomonee Falls, Wisconsin, Forenede Stater, 53051
- Community Memorial Hospital
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53211
- Columbia Hospital
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Milwaukee, Wisconsin, Forenede Stater, 53215
- St. Luke's Medical Center
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Racine, Wisconsin, Forenede Stater, 53405
- All Saints Cancer Center
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Waukesha, Wisconsin, Forenede Stater, 53188
- Waukesha Memorial Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
SYGDOMS KARAKTERISTIKA:
- Histologisk dokumenteret bryst- eller prostatacancer
- Radiografisk bevis for knoglemetastaser inden for 8 uger efter undersøgelsen
Kvalificerede behandlingssteder:
Vægtbærende steder:
- bækken (undtagen pubis)
- Femur
- Sacrum og/eller sacroiliacale led
- Tibia
Ikke-vægtbærende steder:
- Op til 5 på hinanden følgende cervikale, thorax- eller lændehvirvler
- Lumbosakral rygsøjle
- Op til 3 på hinanden følgende ribben
- Humerus
- Fibula
- Radius med/uden ulna
- Nøgleben
- Scapula
- Pubis
- Hvis flere steder behandles, inkluderes stedet som vægtbærende, hvis nogen af stederne inkluderer bækken, korsbenet, lårbenet eller skinnebenet
- Værste smertescore på mindst 5 på en skala fra 10
- Ingen kranie-, fødder- eller håndmetastaser
- Ingen rygmarv eller cauda equina kompression/udsletning i vertebrale metastaser
- Flere steder er kvalificerede, hvis de ikke kan inkluderes på mere end 3 behandlingssteder
PATIENT KARAKTERISTIKA:
Alder:
- 18 og derover
Ydeevnestatus:
- Karnofsky 40-100 %
Forventede levealder:
- Mindst 3 måneder
Hæmatopoietisk:
- Ikke specificeret
Hepatisk:
- Ikke specificeret
Nyre:
- Ikke specificeret
Andet:
- Ingen forestående brud på behandlingsstedet
- Ingen hæmatologiske primære maligniteter
- Negativ graviditetstest
FORUDSÆTNING SAMTYDLIG TERAPI:
Biologisk terapi:
- Ingen ændring i immunterapi inden for 30 dage
Kemoterapi:
- Ingen ændring i kemoterapi inden for 30 dage
Endokrin terapi:
- Ingen ændring i hormonbehandling inden for 30 dage
Strålebehandling:
- Ingen forudgående strålebehandling til behandlingsområdet
- Mindst 30 dage siden systemisk strålebehandling (Sr 89)
Kirurgi:
- Ingen forudgående palliativ kirurgi til behandlingsområdet
- Ingen planlagt kirurgisk fiksering af knoglen
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 3,0 Gy x 10 fraktioner på to uger
3,0 Gy x 10 fraktioner til en samlet dosis på 30,0 Gy på to uger
|
|
Eksperimentel: 8,0 Gy x 1 fraktion
8,0 Gy x 1 fraktion for en samlet dosis på 8,0 Gy i en enkelt dosis
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: William F. Hartsell, MD, Advocate Lutheran General Hospital
- Studiestol: Ivy A. Petersen, MD, Mayo Clinic
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RTOG-9714
- CDR0000065957
- NCCTG-R9714
- NCI-P97-0124
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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