- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00003417
Computerplanlagt strålebehandling plus kemoterapi til behandling af patienter med glioblastoma multiforme
Fase I/II strålingsdosis-eskaleringsundersøgelse med anvendelse af konform strålebehandling ved supratentorial glioblastoma multiforme
RATIONALE: Strålebehandling bruger højenergi-røntgenstråler til at beskadige tumorceller. Computersystemer, der gør det muligt for læger at skabe et 3-dimensionelt billede af tumoren for at planlægge behandling, kan resultere i mere effektiv strålebehandling. Lægemidler, der bruges i kemoterapi, bruger forskellige måder til at stoppe tumorceller i at dele sig, så de holder op med at vokse eller dør. Kombination af strålebehandling med kemoterapi kan dræbe flere tumorceller.
FORMÅL: Fase I/II-forsøg til undersøgelse af effektiviteten af strålebehandling, der er planlagt med en computer plus kemoterapi til behandling af patienter, der har glioblastoma multiforme.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
MÅL:
- Bestem gennemførligheden og toksiciteten af eskalerende doser af konform strålebehandling planlagt med 3-D behandlingsplanlægning plus carmustin hos patienter med glioblastoma multiforme.
- Bestem dosis/volumen og dosis/anatomiske karakteristika, der påvirker stråleterapi-induceret CNS (centralnervesystem) toksicitet.
- Evaluer lokale kontrol-, overlevelses- og svigtmønstre for disse patienter behandlet med høje doser af konform strålebehandling til grov sygdom.
- Korreler ændringer på tværsnitsdiagnostiske MR-billeddannelsesundersøgelser til kliniske eller biologiske endepunkter.
OVERSIGT: Dette er en dosis-eskaleringsundersøgelse. Patienterne stratificeres i henhold til det planlagte målvolumen, dvs. brutto resterende tumor plus 3 mm (mindre end 75 cc vs mindst 75 cc).
Patienterne gennemgår strålebehandling over 15-30 minutter dagligt 5 dage om ugen i 6-8 uger. Efter at 46 Gy strålebehandling er blevet administreret, gennemgår patienterne strålebehandlingsfeltreduktion og opsamles i et af fire dosisniveauer. (Dosisniveau 1 lukket til periodisering 1/16/01) Alle patienter modtager mindst 33 strålebehandlinger. Hver patient evalueres for akut dosisbegrænsende toksicitet i 90 dage fra behandlingsstart.
Patienter får også carmustin IV over 1-2 timer dagligt på dag 1-3 i den første uge af strålebehandling. Behandlingen gentages hver 8. uge i op til 6 forløb.
Patienterne følges hver 4. måned i 2 år, hver 6. måned i 1 år og derefter årligt.
PROJEKTERET TILSLUTNING: I alt 40 patienter (20 pr. arm) vil blive akkumuleret til denne undersøgelse inden for mindst 5 måneder.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
- Fase 1
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
-
-
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
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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
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
-
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Quebec
-
Fleurimont, Quebec, Canada, J1H 5N4
- CHUS-Hopital Fleurimont
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Montreal, Quebec, Canada, H2W 1S6
- McGill University
-
Montreal, Quebec, Canada, H2L 4MI
- Centre Hospitalier de l'Université de Montréal
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Quebec City, Quebec, Canada, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
-
-
Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
-
Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
-
-
-
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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, 35807
- Huntsville Hospital System
-
Mobile, Alabama, Forenede Stater, 36688
- MBCCOP - Gulf Coast
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Montgomery, Alabama, Forenede Stater, 36106-3657
- Alabama Oncology, LLC
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Tuscaloosa, Alabama, Forenede Stater, 35401
- DCH Cancer Treatment Center
-
-
Arizona
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Phoenix, Arizona, Forenede Stater, 85013
- Foundation for Cancer Research and Education
-
-
California
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Concord, California, Forenede Stater, 94524-4110
- Mount Diablo Medical Center
-
Duarte, California, Forenede Stater, 91010-3000
- City of Hope Comprehensive Cancer Center
-
Fresno, California, Forenede Stater, 93720
- Saint Agnes Cancer Center
-
Fresno, California, Forenede Stater, 93729-5100
- California Cancer Center
-
Greenbrae, California, Forenede Stater, 94904
- Sutter Health Western Division 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, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Forenede Stater, 90025-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Oakland, California, Forenede Stater, 94609-3305
- CCOP - Bay Area Tumor Institute
-
Pasadena, California, Forenede Stater, 91105
- Huntington Cancer Center
-
Pomona, California, Forenede Stater, 91767
- Robert and Beverly Lewis Family Cancer Care Center
-
Sacramento, California, Forenede Stater, 95816
- Radiation Oncology Center - Sacramento
-
San Diego, California, Forenede Stater, 92101
- Radiation Medical Group, Incorporated
-
San Francisco, California, Forenede Stater, 94143-0128
- UCSF Comprehensive Cancer Center
-
San Jose, California, Forenede Stater, 95128
- O'Connor Hospital
-
Santa Rosa, California, Forenede Stater, 95403
- CCOP - Santa Rosa Memorial Hospital
-
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
-
Denver, Colorado, Forenede Stater, 80224
- CCOP - Colorado Cancer Research Program, Incorporated
-
Grand Junction, Colorado, Forenede Stater, 81502-1628
- Saint Mary's Hospital and Medical Center
-
-
Delaware
-
Newark, Delaware, Forenede Stater, 19713
- CCOP - Christiana Care Health Services
-
-
Florida
-
Gainesville, Florida, Forenede Stater, 32610-0385
- University of Florida Health Science Center
-
Jacksonville, Florida, Forenede Stater, 32207
- Florida Radiation Oncology Group
-
Melbourne, Florida, Forenede Stater, 32901-3276
- Holmes Regional Medical Center
-
Miami, Florida, Forenede Stater, 33136
- Sylvester Cancer Center, University of Miami
-
Miami, Florida, Forenede Stater, 33125
- Veterans Affairs Medical Center - Miami
-
Miami, Florida, Forenede Stater, 33256-2110
- Baptist Hospital of Miami
-
Miami Beach, Florida, Forenede Stater, 33140
- CCOP - Mount Sinai Medical Center
-
Orlando, Florida, Forenede Stater, 32806-2134
- 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, 31901
- 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
-
-
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
- Community Regional Cancer Care
-
Muncie, Indiana, Forenede Stater, 47303-3499
- Ball Memorial Hospital
-
South Bend, Indiana, Forenede Stater, 46601
- CCOP - Northern Indiana CR Consortium
-
-
Iowa
-
Dubuque, Iowa, Forenede Stater, 52001
- Wendt Regional Cancer Center of Finley Hospital
-
-
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
- Cancer Center at Lexington Clinic
-
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
-
Baton Rouge, Louisiana, Forenede Stater, 70809
- Mary Bird Perkins Cancer Center
-
New Orleans, Louisiana, Forenede Stater, 70121
- CCOP - Ochsner
-
New Orleans, Louisiana, Forenede Stater, 70112
- MBCCOP - LSU Health Sciences Center
-
New Orleans, Louisiana, Forenede Stater, 70112-2699
- Tulane University School of Medicine
-
-
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, 21215
- Sinai Hospital of Baltimore
-
Baltimore, Maryland, Forenede Stater, 21201
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
-
Baltimore, Maryland, Forenede Stater, 21204
- Greater Baltimore Medical Center and Cancer Center
-
Baltimore, Maryland, Forenede Stater, 21215-1290
- Harbor Hospital Center
-
Salisbury, Maryland, Forenede Stater, 21801
- Peninsula Regional Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02114
- Dana-Farber Cancer Institute
-
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, 48106
- CCOP - Michigan Cancer Research Consortium
-
Ann Arbor, Michigan, Forenede Stater, 48109-0010
- University of Michigan Comprehensive Cancer Center
-
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, 48532-3685
- 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, 48073-6769
- CCOP - Beaumont
-
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, 68106
- CCOP - Missouri Valley Cancer Consortium
-
Omaha, Nebraska, Forenede Stater, 68114
- Methodist Hospital Cancer Center - Omaha
-
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
-
East Orange, New Jersey, Forenede Stater, 07019
- 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
-
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 Virtua Health Cancer Program at Virtua Memorial Hospital
-
New Brunswick, New Jersey, Forenede Stater, 38103-2807
- 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
-
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
-
Brooklyn, New York, Forenede Stater, 11203
- State University of New York Health Science Center at Brooklyn
-
Brooklyn, New York, Forenede Stater, 11215
- New York Methodist Hospital
-
Buffalo, New York, Forenede Stater, 14263-0001
- Roswell Park Cancer Institute
-
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, 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 Medical Center
-
Rochester, New York, Forenede Stater, 14642
- James P. Wilmot Cancer Center
-
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
-
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
-
Minot, North Dakota, Forenede Stater, 58701
- Trinity Cancer Care Center
-
-
Ohio
-
Akron, Ohio, Forenede Stater, 44302
- Akron General Medical Center
-
Akron, Ohio, Forenede Stater, 44304
- Akron City Hospital
-
Cincinnati, Ohio, Forenede Stater, 45219
- Christ Hospital
-
Cincinnati, Ohio, Forenede Stater, 45267-0502
- Barrett Cancer Center
-
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
-
Columbus, Ohio, Forenede Stater, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
-
Columbus, Ohio, Forenede Stater, 43206
- CCOP - Columbus
-
Dayton, Ohio, Forenede Stater, 45429
- CCOP - Dayton
-
Toledo, Ohio, Forenede Stater, 43623-3456
- CCOP - Toledo Community Hospital
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma Health Sciences Center
-
Oklahoma City, Oklahoma, Forenede Stater, 73101
- St. Anthony Hospital
-
Tulsa, Oklahoma, Forenede Stater, 74136
- CCOP - Oklahoma
-
Tulsa, Oklahoma, Forenede Stater, 74104
- St. John Health System
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97225
- CCOP - Columbia River Oncology Program
-
-
Pennsylvania
-
Allentown, Pennsylvania, Forenede Stater, 18105
- Lehigh Valley Hospital
-
Bethlehem, Pennsylvania, Forenede Stater, 18015
- St. Luke's Hospital 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, 19104-4283
- Abramson Cancer Center of the University of Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- Veterans Affairs Medical Center - Philadelphia
-
Philadelphia, Pennsylvania, Forenede Stater, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
-
Philadelphia, Pennsylvania, Forenede Stater, 19141-3098
- Albert Einstein Cancer Center
-
Pittsburgh, Pennsylvania, Forenede Stater, 15224
- Western Pennsylvania Hospital
-
Pittsburgh, Pennsylvania, Forenede Stater, 15219
- Mercy Hospital of Pittsburgh
-
Pittsburgh, Pennsylvania, Forenede Stater, 15236
- University of Pittsburgh Cancer Institute
-
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, 17403
- York Cancer Center
-
-
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
-
-
Tennessee
-
Jackson, Tennessee, Forenede Stater, 38301-3956
- Jackson-Madison County General Hospital
-
Memphis, Tennessee, Forenede Stater, 38103
- University of Tennessee Cancer Institute
-
Nashville, Tennessee, Forenede Stater, 37232-5671
- 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 Medical Center
-
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
-
Burlington, Vermont, Forenede Stater, 05401
- Green Mountain Oncology Group
-
Burlington, Vermont, Forenede Stater, 05405-0075
- 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, 23226
- Bon Secours - St. Mary's Hospital
-
Richmond, Virginia, Forenede Stater, 23298-0058
- Massey Cancer Center
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98111
- Virginia Mason Medical Center
-
Spokane, Washington, Forenede Stater, 99204
- Deaconess Medical Center
-
Yakima, Washington, Forenede Stater, 98902
- Yakima Valley Memorial Hospital
-
-
West Virginia
-
Wheeling, West Virginia, Forenede Stater, 26003
- Schiffler Cancer Center
-
-
Wisconsin
-
Green Bay, Wisconsin, Forenede Stater, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
-
Green Bay, Wisconsin, Forenede Stater, 54307-3508
- St. Vincent Hospital
-
La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Medical Foundation
-
Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin Comprehensive Cancer Center
-
Madison, Wisconsin, Forenede Stater, 53713
- Southern Wisconsin Radiotherapy Center
-
Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Clinic
-
Menomonee Falls, Wisconsin, Forenede Stater, 53051
- Community Memorial Hospital
-
Milwaukee, Wisconsin, Forenede Stater, 53211
- Columbia Hospital
-
Milwaukee, Wisconsin, Forenede Stater, 53215
- St. Luke's Medical Center
-
Milwaukee, Wisconsin, Forenede Stater, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin Cancer 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 Regional Cancer Center
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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 bekræftet glioblastoma multiforme med områder med nekrose som diagnosticeret ved kirurgisk biopsi eller subtotal excision
- Supratentorial tumor
- Brutto målbar restsygdom
- Ingen veldifferentieret eller anaplastisk astrocytom, multifokal gliom eller tilbagevendende glioblastoma multiforme
- Behandlingen skal påbegyndes inden for 5 uger efter operationen, men inden for 1 uge efter registreringen
CT- eller MR-scanning præoperativt og MR postoperativt før påbegyndelse af strålebehandling
- Hvis du gennemgår en stereotaktisk-styret nålebiopsi, er det ikke nødvendigt at gentage MR efter proceduren, hvis præbiopsi-MR er egnet til behandlingsplanlægning
- Forudgående fuldstændig kirurgisk resektion af tumor tilladt
PATIENT KARAKTERISTIKA:
Alder:
- 18 og derover
Ydeevnestatus:
- Karnofsky 60-100 %
Forventede levealder:
- Ikke specificeret
Hæmatopoietisk:
- Absolut neutrofiltal mindst 1.500/mm^3
- Blodpladetal mindst 100.000/mm^3
- Hæmoglobin mindst 9 g/dL
Hepatisk:
- Bilirubin ikke større end 2 mg/dL
- SGPT (serum glutamat pyruvat transaminase) eller SGOT (serum glutamic oxaloeddikesyre transaminase) ikke mere end 2 gange normal
Nyre:
- BUN (blod urea nitrogen) ikke større end 30 mg/dL
- Kreatinin ikke større end 1,8 mg/dL
Lunge:
- Normal røntgen af thorax ELLER
- DLCO (carbonmonoxid diffuserende kapacitet) mindst 60% forudsagt
Andet:
- Ikke gravid
- Negativ graviditetstest
- Fertile patienter skal bruge effektiv prævention
- Ingen anden malignitet inden for de seneste 5 år undtagen carcinom in situ i livmoderhalsen eller blæren, duktalt carcinom in situ i brystet eller ikke-melanomatøs hudkræft
- Neurologisk funktionsstatus 0-3
- Ingen større medicinsk sygdom eller psykiatriske funktionsnedsættelser, der ville udelukke studiedeltagelse
FORUDSÆTNING SAMTYDLIG TERAPI:
Biologisk terapi:
- Ikke specificeret
Kemoterapi:
- Ingen forudgående systemisk kemoterapi
Endokrin terapi:
- Ikke specificeret
Strålebehandling:
- Ingen forudgående strålebehandling til hoved eller nakke
Kirurgi:
- Se Sygdomskarakteristika
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Jeff M. Michalski, MD, Washington University Siteman Cancer Center
Publikationer og nyttige links
Generelle publikationer
- Corn BW, Wang M, Fox S, Michalski J, Purdy J, Simpson J, Kresl J, Curran WJ Jr, Diaz A, Mehta M, Movsas B. Health related quality of life and cognitive status in patients with glioblastoma multiforme receiving escalating doses of conformal three dimensional radiation on RTOG 98-03. J Neurooncol. 2009 Nov;95(2):247-257. doi: 10.1007/s11060-009-9923-3. Epub 2009 Jun 16.
- Tsien C, Moughan J, Michalski JM, Gilbert MR, Purdy J, Simpson J, Kresel JJ, Curran WJ, Diaz A, Mehta MP; Radiation Therapy Oncology Group Trial 98-03. Phase I three-dimensional conformal radiation dose escalation study in newly diagnosed glioblastoma: Radiation Therapy Oncology Group Trial 98-03. Int J Radiat Oncol Biol Phys. 2009 Mar 1;73(3):699-708. doi: 10.1016/j.ijrobp.2008.05.034. Epub 2008 Aug 23.
- Souhami L, Seiferheld W, Brachman D, Podgorsak EB, Werner-Wasik M, Lustig R, Schultz CJ, Sause W, Okunieff P, Buckner J, Zamorano L, Mehta MP, Curran WJ Jr. Randomized comparison of stereotactic radiosurgery followed by conventional radiotherapy with carmustine to conventional radiotherapy with carmustine for patients with glioblastoma multiforme: report of Radiation Therapy Oncology Group 93-05 protocol. Int J Radiat Oncol Biol Phys. 2004 Nov 1;60(3):853-60. doi: 10.1016/j.ijrobp.2004.04.011.
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
Yderligere relevante MeSH-vilkår
- Sygdomme i nervesystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Astrocytom
- Gliom
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Glioblastom
- Neoplasmer i nervesystemet
- Neoplasmer i centralnervesystemet
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Carmustine
Andre undersøgelses-id-numre
- RTOG-9803
- CDR0000066432
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