- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00006388
Stråleterapi og tamoksifen ved behandling av voksne med nylig diagnostisert supratentorial glioblastoma multiforme
En fase II-studie av høydose Tamoxifen for behandling av nylig diagnostisert supratentorial glioblastoma multiforme (GBM)
BAKGRUNN: Strålebehandling bruker høyenergirøntgenstråler for å skade tumorceller. Legemidler som tamoxifen kan gjøre tumorcellene mer følsomme for strålebehandling.
FORMÅL: Fase II studie for å studere effektiviteten av å kombinere strålebehandling med tamoxifen i behandling av pasienter som nylig har diagnostisert supratentorielt glioblastoma multiforme.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
MÅL: I. Finn ut om høydose tamoxifen initiert i begynnelsen av konvensjonell strålebehandling forbedrer median overlevelsestid for voksne med nylig diagnostisert, supratentorielt glioblastoma multiforme. II. Bestem gjennomførbarheten og toksisiteten til høydose tamoxifen hos disse pasientene. III. Bestem den totale overlevelsen med hensyn til proteinkinase C-labkorrelater hos pasienter behandlet med dette regimet.
OVERSIKT: Dette er en multisenterstudie. Fra og med 5 uker etter operasjonen gjennomgår pasienter strålebehandling til hjernen 5 dager i uken i 6 uker. Pasienter får høydose oral tamoksifen hver 6. time fra dag 1 av strålebehandling og fortsetter i fravær av sykdomsprogresjon. Pasientene følges hver 3. måned gjennom år 1, hver 4. måned i 1 år, hver 6. måned i 2 år, og deretter årlig.
PROSJERT PASSERING: Totalt 72 pasienter vil bli påløpt for denne studien innen 6 måneder.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Center - Calgary
-
Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 4E6
- British Columbia Cancer Agency
-
-
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 - General Campus
-
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'Université de Montréal
-
Quebec City, Quebec, Canada, G1R 2J6
- CHU de Quebec - L'Hotel-Dieu de Quebec
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
-
Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
-
-
-
-
Alabama
-
Birmingham, Alabama, Forente stater, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
-
Huntsville, Alabama, Forente stater, 35801
- Comprehensive Cancer Institute of Huntsville
-
Huntsville, Alabama, Forente stater, 35801-4470
- Huntsville Hospital System
-
Mobile, Alabama, Forente stater, 36688
- MBCCOP - Gulf Coast
-
Montgomery, Alabama, Forente stater, 36106-2801
- Alabama Oncology, LLC
-
Tuscaloosa, Alabama, Forente stater, 35401
- Radiation Oncology Associates of West Alabama
-
-
Alaska
-
Anchorage, Alaska, Forente stater, 99508
- Providence Alaska Medical Center
-
-
Arizona
-
Tucson, Arizona, Forente stater, 85724
- Arizona Cancer Center
-
-
Arkansas
-
Little Rock, Arkansas, Forente stater, 72205
- University of Arkansas for Medical Sciences
-
-
California
-
Concord, California, Forente stater, 94524-4110
- Mount Diablo Medical Center
-
Duarte, California, Forente stater, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
-
Fresno, California, Forente stater, 93720
- California Cancer Center
-
Fresno, California, Forente stater, 93720
- Saint Agnes Cancer Center
-
Glendale, California, Forente stater, 91204
- Glendale Memorial Hospital and Health Center
-
Greenbrae, California, Forente stater, 94904
- Sutter Health West Cancer Research Group
-
La Jolla, California, Forente stater, 92093-0658
- University of California San Diego Cancer Center
-
Loma Linda, California, Forente stater, 92354
- Loma Linda University Medical Center
-
Long Beach, California, Forente stater, 90822
- Veterans Affairs Medical Center - Long Beach
-
Los Angeles, California, Forente stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
Los Angeles, California, Forente stater, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
-
Oakland, California, Forente stater, 94609-3305
- CCOP - Bay Area Tumor Institute
-
Pasadena, California, Forente stater, 91105
- Huntington Cancer Center
-
Pomona, California, Forente stater, 91767
- Cancer Care Center
-
Sacramento, California, Forente stater, 95816
- Radiation Oncology Center - Sacramento
-
San Diego, California, Forente stater, 92101-1492
- Radiation Medical Group, Inc.
-
San Francisco, California, Forente stater, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
-
San Jose, California, Forente stater, 95128
- O'Connor Hospital
-
Santa Rosa, California, Forente stater, 95403
- CCOP - Santa Rosa Memorial Hospital
-
Travis Air Force Base, California, Forente stater, 94535
- David Grant Medical Center
-
-
Colorado
-
Colorado Springs, Colorado, Forente stater, 80909
- Memorial Hospital Cancer Center
-
Denver, Colorado, Forente stater, 80010
- University of Colorado Cancer Center
-
Grand Junction, Colorado, Forente stater, 81502
- Saint Mary's Hospital and Medical Center
-
-
Delaware
-
Wilmington, Delaware, Forente stater, 19899
- CCOP - Christiana Care Health Services
-
-
District of Columbia
-
Washington, District of Columbia, Forente stater, 20307-5000
- Walter Reed Army Medical Center
-
-
Florida
-
Clearwater, Florida, Forente stater, 33757-0210
- Lykes Center for Radiation Therapy
-
Daytona Beach, Florida, Forente stater, 32114
- Halifax Medical Center
-
Fort Myers, Florida, Forente stater, 33901
- Radiation Therapy Associates - Fort Myers
-
Gainesville, Florida, Forente stater, 32610-0296
- University of Florida Health Science Center
-
Melbourne, Florida, Forente stater, 32901
- Health First Holmes Regional Medical Center
-
Miami, Florida, Forente stater, 33136
- Sylvester Cancer Center, University of Miami
-
Miami, Florida, Forente stater, 33176-2197
- Baptist Hospital of Miami
-
Miami, Florida, Forente stater, 33125
- Veterans Affairs Medical Center - Miami
-
Miami Beach, Florida, Forente stater, 33140
- CCOP - Mount Sinai Medical Center
-
Orange Park, Florida, Forente stater, 32073
- Florida Radiation Oncology Group
-
Orlando, Florida, Forente stater, 32806
- MD Anderson Cancer Center Orlando
-
Panama City, Florida, Forente stater, 32405-4587
- Gulf Coast Cancer Treatment Center
-
Panama City, Florida, Forente stater, 32401
- Bay Medical Center
-
Sarasota, Florida, Forente stater, 34233
- Sarasota Radiation and Medical Oncology Center
-
Tallahassee, Florida, Forente stater, 32308
- Tallahassee Memorial HealthCare
-
Tampa, Florida, Forente stater, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30322
- Emory University Hospital - Atlanta
-
Atlanta, Georgia, Forente stater, 30342-1701
- CCOP - Atlanta Regional
-
Columbus, Georgia, Forente stater, 31902
- Medical Center/John B. Amos Community Cancer Center
-
Rome, Georgia, Forente stater, 30165
- InterCommunity Cancer Center at Rome
-
-
Illinois
-
Arlington Heights, Illinois, Forente stater, 60005
- Northwest Community Hospital
-
Chicago, Illinois, Forente stater, 60637-1470
- University of Chicago Cancer Research Center
-
Chicago, Illinois, Forente stater, 60611
- Northwestern Memorial Hospital
-
Decatur, Illinois, Forente stater, 62526
- CCOP - Central Illinois
-
Elgin, Illinois, Forente stater, 60123
- Provena St. Joseph Hospital- Regional Cancer Care Center
-
Harvey, Illinois, Forente stater, 60426
- Ingalls Memorial Hospital
-
Maywood, Illinois, Forente stater, 60153
- Loyola University Medical Center
-
Park Ridge, Illinois, Forente stater, 60068
- Lutheran General Cancer Care Center
-
Peoria, Illinois, Forente stater, 61636
- Methodist Medical Center of Illinois
-
-
Indiana
-
Anderson, Indiana, Forente stater, 46016
- St. John's Medical Center
-
Bloomington, Indiana, Forente stater, 47402
- Bloomington Hospital
-
Indianapolis, Indiana, Forente stater, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
-
Indianapolis, Indiana, Forente stater, 46206-1367
- Clarion Health Partners Inc.
-
Indianapolis, Indiana, Forente stater, 46219
- Community Hospitals of Indianapolis - Regional Cancer Center
-
Muncie, Indiana, Forente stater, 47303-3499
- Ball Memorial Hospital
-
-
Iowa
-
Dubuque, Iowa, Forente stater, 52001
- Wendt Regional Cancer Center of Finley Hospital
-
Iowa City, Iowa, Forente stater, 52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
-
-
Kentucky
-
Lexington, Kentucky, Forente stater, 40511-1093
- Veterans Affairs Medical Center - Lexington
-
Lexington, Kentucky, Forente stater, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
-
Lexington, Kentucky, Forente stater, 40503
- Central Baptist Hospital
-
Louisville, Kentucky, Forente stater, 40202
- James Graham Brown Cancer Center
-
Louisville, Kentucky, Forente stater, 40215
- Louisville Radiation Oncology
-
Madisonville, Kentucky, Forente stater, 42431
- Merle M. Mahr Cancer Center
-
-
Louisiana
-
Baton Rouge, Louisiana, Forente stater, 70809
- Mary Bird Perkins Cancer Center
-
Lafayette, Louisiana, Forente stater, 70501
- Romagosa Radiation Oncology Center
-
New Orleans, Louisiana, Forente stater, 70112
- Tulane University School of Medicine
-
New Orleans, Louisiana, Forente stater, 70121
- CCOP - Ochsner
-
New Orleans, Louisiana, Forente stater, 70112
- MBCCOP - LSU Health Sciences Center
-
-
Maine
-
Portland, Maine, Forente stater, 04102
- Maine Medical Center
-
-
Maryland
-
Annapolis, Maryland, Forente stater, 21401
- Anne Arundel Oncology Center
-
Baltimore, Maryland, Forente stater, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
Baltimore, Maryland, Forente stater, 21225
- Sinai Hospital of Baltimore
-
Baltimore, Maryland, Forente stater, 21204
- Greater Baltimore Medical Center and Cancer Center
-
Baltimore, Maryland, Forente stater, 21225
- Harbor Hospital Center
-
Baltimore, Maryland, Forente stater, 21237
- Radiation Oncology Affiliates of Maryland, P.A.
-
Salisbury, Maryland, Forente stater, 21801
- Peninsula Regional Medical Center
-
-
Massachusetts
-
Hyannis, Massachusetts, Forente stater, 02601
- Cape Cod Hospital
-
Jamaica Plain, Massachusetts, Forente stater, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
-
-
Michigan
-
Ann Arbor, Michigan, Forente stater, 48109-0752
- University Of Michigan Comprehensive Cancer Center
-
Ann Arbor, Michigan, Forente stater, 48106
- CCOP - Ann Arbor Regional
-
Detroit, Michigan, Forente stater, 48202
- Henry Ford Hospital
-
Detroit, Michigan, Forente stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
-
Flint, Michigan, Forente stater, 48503
- Hurley Medical Center
-
Flint, Michigan, Forente stater, 48432
- McLaren Regional Cancer Center
-
Kalamazoo, Michigan, Forente stater, 49007-3731
- CCOP - Kalamazoo
-
Marquette, Michigan, Forente stater, 49855
- Marquette General Hospital
-
Midland, Michigan, Forente stater, 48670
- MidMichigan Medical Center - Midland
-
Royal Oak, Michigan, Forente stater, 48073
- William Beaumont Hospital
-
Saginaw, Michigan, Forente stater, 48601
- St. Mary's Medical Center
-
Troy, Michigan, Forente stater, 48098
- William Beaumont Hospital - Troy
-
-
Minnesota
-
Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic Cancer Center
-
Saint Louis Park, Minnesota, Forente stater, 55416
- CCOP - Metro-Minnesota
-
-
Mississippi
-
Tupelo, Mississippi, Forente stater, 38801
- North Mississippi Medical Center/Cancer Center
-
-
Missouri
-
Columbia, Missouri, Forente stater, 65203
- Ellis Fischel Cancer Center - Columbia
-
Kansas City, Missouri, Forente stater, 64131
- CCOP - Kansas City
-
Saint Louis, Missouri, Forente stater, 63110-0250
- St. Louis University Health Sciences Center
-
Saint Louis, Missouri, Forente stater, 63110
- Mallinckrodt Institute of Radiology
-
Springfield, Missouri, Forente stater, 65807
- CCOP - Cancer Research for the Ozarks
-
Springfield, Missouri, Forente stater, 65807
- Cancer Research for the Ozarks
-
-
Montana
-
Billings, Montana, Forente stater, 59101
- CCOP - Montana Cancer Consortium
-
-
Nebraska
-
Omaha, Nebraska, Forente stater, 68114
- Methodist Cancer Center - Omaha
-
Omaha, Nebraska, Forente stater, 68105-1018
- Nebraska Health System
-
-
Nevada
-
Las Vegas, Nevada, Forente stater, 89106
- CCOP - Southern Nevada Cancer Research Foundation
-
-
New Hampshire
-
Lebanon, New Hampshire, Forente stater, 03756-0002
- Norris Cotton Cancer Center
-
Manchester, New Hampshire, Forente stater, 03103
- Elliot Regional Cancer Center
-
-
New Jersey
-
East Orange, New Jersey, Forente stater, 07018-1095
- Veterans Affairs Medical Center - East Orange
-
Edison, New Jersey, Forente stater, 08818
- John F. Kennedy Medical Center
-
Elizabeth, New Jersey, Forente stater, 07201
- Trinitas Hospital - Jersey Street Campus
-
Long Branch, New Jersey, Forente stater, 07740-6395
- Monmouth Medical Center
-
Millville, New Jersey, Forente stater, 08332
- South Jersey Regional Cancer Center
-
Mount Holly, New Jersey, Forente stater, 08060
- Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
-
New Brunswick, New Jersey, Forente stater, 08901
- Cancer Institute Of New Jersey
-
Newark, New Jersey, Forente stater, 07112
- Newark Beth Israel Medical Center
-
Pomona, New Jersey, Forente stater, 08240
- Atlantic City Medical Center
-
Ridgewood, New Jersey, Forente stater, 07450
- Valley Hospital
-
Toms River, New Jersey, Forente stater, 08755
- Community Medical Center
-
Trenton, New Jersey, Forente stater, 08629
- St. Francis Medical Center
-
Warren, New Jersey, Forente stater, 07059
- Associated Radiologists, P.A.
-
-
New Mexico
-
Albuquerque, New Mexico, Forente stater, 87102
- Saint Joseph Medical Center
-
-
New York
-
Albany, New York, Forente stater, 12208
- Cancer Center of Albany Medical Center
-
Bronx, New York, Forente stater, 10461
- Albert Einstein Comprehensive Cancer Center
-
Brooklyn, New York, Forente stater, 11203
- State University of New York Health Science Center at Brooklyn
-
Brooklyn, New York, Forente stater, 11215-3609
- New York Methodist Hospital
-
Buffalo, New York, Forente stater, 14263-0001
- Roswell Park Cancer Institute
-
Clifton Springs, New York, Forente stater, 14432
- Finger Lakes Radiation Oncology, P.C.
-
Manhasset, New York, Forente stater, 11030
- CCOP - North Shore University Hospital
-
New York, New York, Forente stater, 10021
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, Forente stater, 10003
- Beth Israel Medical Center
-
New York, New York, Forente stater, 10032
- Herbert Irving Comprehensive Cancer Center
-
Plattsburgh, New York, Forente stater, 12901
- Champlain Valley Physicians Hospital Medical Center
-
Poughkeepsie, New York, Forente stater, 12601
- Vassar Brothers Hospital
-
Rochester, New York, Forente stater, 14642
- University of Rochester Cancer Center
-
Valhalla, New York, Forente stater, 10595
- New York Medical College
-
Yonkers, New York, Forente stater, 10701
- Riverhill Radiation Oncology
-
-
North Carolina
-
Chapel Hill, North Carolina, Forente stater, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
-
Concord, North Carolina, Forente stater, 28025
- Northeast Medical Center
-
Greenville, North Carolina, Forente stater, 27858-4354
- East Carolina University School of Medicine
-
Hickory, North Carolina, Forente stater, 28601
- Catawba Memorial Hospital
-
Winston-Salem, North Carolina, Forente stater, 27104-4241
- CCOP - Southeast Cancer Control Consortium
-
Winston-Salem, North Carolina, Forente stater, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
-
-
North Dakota
-
Fargo, North Dakota, Forente stater, 58122
- Meritcare Roger Maris Cancer Center
-
Minot, North Dakota, Forente stater, 58701
- Trinity Cancer Care Center
-
-
Ohio
-
Akron, Ohio, Forente stater, 44302
- Akron General Medical Center
-
Akron, Ohio, Forente stater, 44309
- Akron City Hospital
-
Cincinnati, Ohio, Forente stater, 45219
- Barrett Cancer Center, The University Hospital
-
Cincinnati, Ohio, Forente stater, 45219
- Christ Hospital
-
Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland, Ohio, Forente stater, 44106
- University Hospitals of Cleveland
-
Cleveland, Ohio, Forente stater, 44106-5065
- Ireland Cancer Center
-
Columbus, Ohio, Forente stater, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
-
Columbus, Ohio, Forente stater, 43206
- CCOP - Columbus
-
Kettering, Ohio, Forente stater, 45429
- CCOP - Dayton
-
Toledo, Ohio, Forente stater, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forente stater, 73104
- Oklahoma University Medical Center
-
Oklahoma City, Oklahoma, Forente stater, 73101
- St. Anthony Hospital
-
Tulsa, Oklahoma, Forente stater, 74104
- St. John Health System
-
-
Oregon
-
Portland, Oregon, Forente stater, 97213
- CCOP - Columbia River Program
-
-
Pennsylvania
-
Allentown, Pennsylvania, Forente stater, 18103
- LeHigh Valley Hospital
-
Bethlehem, Pennsylvania, Forente stater, 18015
- St. Luke's Hospital Regional Cancer Center
-
Danville, Pennsylvania, Forente stater, 17822-2001
- Geisinger Medical Center
-
Darby, Pennsylvania, Forente stater, 19023
- Fitzgerald Mercy Hospital
-
Drexel Hill, Pennsylvania, Forente stater, 19026
- Delaware County Memorial Hospital
-
East Stroudsburg, Pennsylvania, Forente stater, 18301
- Pocono Cancer Center
-
Hershey, Pennsylvania, Forente stater, 17033
- Penn State Geisinger Cancer Center
-
Philadelphia, Pennsylvania, Forente stater, 19111
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Forente stater, 19104
- Veterans Affairs Medical Center - Philadelphia
-
Philadelphia, Pennsylvania, Forente stater, 19141
- Albert Einstein Cancer Center
-
Philadelphia, Pennsylvania, Forente stater, 19102-1192
- Hahnemann University Hospital
-
Philadelphia, Pennsylvania, Forente stater, 19104-4283
- University of Pennsylvania Cancer Center
-
Philadelphia, Pennsylvania, Forente stater, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
-
Pittsburgh, Pennsylvania, Forente stater, 15224
- Western Pennsylvania Hospital
-
Pittsburgh, Pennsylvania, Forente stater, 15213-3489
- University of Pittsburgh Cancer Institute
-
Pittsburgh, Pennsylvania, Forente stater, 15219
- Mercy Hospital of Pittsburgh
-
Reading, Pennsylvania, Forente stater, 19612-6052
- Reading Hospital and Medical Center
-
Scranton, Pennsylvania, Forente stater, 18501
- Mercy Hospital Cancer Center - Scranton
-
Sellersville, Pennsylvania, Forente stater, 18960
- Grand View Hospital
-
Wilkes-Barre, Pennsylvania, Forente stater, 18764
- Wilkes Barre General Hospital
-
Wynnewood, Pennsylvania, Forente stater, 19096
- CCOP - MainLine Health
-
York, Pennsylvania, Forente stater, 17315
- York Hospital
-
-
Rhode Island
-
Providence, Rhode Island, Forente stater, 02908-4735
- Roger Williams Medical Center/BUSM
-
-
South Carolina
-
Charleston, South Carolina, Forente stater, 29425-0721
- Medical University of South Carolina
-
Greenville, South Carolina, Forente stater, 29615
- CCOP - Greenville
-
Spartanburg, South Carolina, Forente stater, 29303
- CCOP - Upstate Carolina
-
-
South Dakota
-
Rapid City, South Dakota, Forente stater, 57709
- Rapid City Regional Hospital
-
-
Tennessee
-
Jackson, Tennessee, Forente stater, 38301
- Jackson-Madison County General Hospital
-
Memphis, Tennessee, Forente stater, 38103
- University of Tennessee, Memphis Cancer Center
-
Nashville, Tennessee, Forente stater, 37232-6838
- Vanderbilt-Ingram Cancer Center
-
-
Texas
-
Amarillo, Texas, Forente stater, 79106
- Harrington Cancer Center
-
Beaumont, Texas, Forente stater, 77701
- Julie and Ben Rogers Cancer Institute
-
Galveston, Texas, Forente stater, 77555-0209
- University of Texas Medical Branch
-
Houston, Texas, Forente stater, 77030-4009
- University of Texas - MD Anderson Cancer Center
-
Lackland Air Force Base, Texas, Forente stater, 78236-5300
- Wilford Hall - 59th Medical Wing
-
Lubbock, Texas, Forente stater, 79410-1894
- Joe Arrington Cancer Research and Treatment Center
-
Pasadena, Texas, Forente stater, 77504
- Bayshore Medical Center
-
Tyler, Texas, Forente stater, 75701
- East Texas Medical Center - Cancer Institute
-
-
Utah
-
Saint George, Utah, Forente stater, 84770
- Dixie Regional Medical Center
-
Salt Lake City, Utah, Forente stater, 84132
- University of Utah Health Sciences Center
-
Salt Lake City, Utah, Forente stater, 84143
- LDS Hospital
-
-
Vermont
-
Bennington, Vermont, Forente stater, 05201
- CCOP - Southwestern Vermont Regional Cancer Center
-
Burlington, Vermont, Forente stater, 05401-3498
- Vermont Cancer Center
-
-
Virginia
-
Charlottesville, Virginia, Forente stater, 22901
- Martha Jefferson Hospital
-
Charlottesville, Virginia, Forente stater, 22908
- Cancer Center at the University of Virginia
-
Harrisonburg, Virginia, Forente stater, 22801
- RMH Regional Canter Center
-
Portsmouth, Virginia, Forente stater, 23708-2197
- Naval Medical Center, Portsmouth
-
Richmond, Virginia, Forente stater, 23298-0037
- Massey Cancer Center
-
Richmond, Virginia, Forente stater, 23226
- Bon-Secours - St. Mary's Hospital
-
-
Washington
-
Seattle, Washington, Forente stater, 98111
- Virginia Mason Medical Center
-
Spokane, Washington, Forente stater, 99210-0248
- Deaconess Medical Center
-
Yakima, Washington, Forente stater, 98902
- Yakima Valley Memorial Hospital
-
-
West Virginia
-
Wheeling, West Virginia, Forente stater, 26003
- Schiffler Cancer Center
-
-
Wisconsin
-
Green Bay, Wisconsin, Forente stater, 54307-3508
- St. Vincent Hospital
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La Crosse, Wisconsin, Forente stater, 54601
- Gundersen Lutheran Medical Foundation
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Madison, Wisconsin, Forente stater, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Madison, Wisconsin, Forente stater, 53713
- Southern Wisconsin Radiotherapy Center
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Marshfield, Wisconsin, Forente stater, 54449
- Marshfield Clinic
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Menomonee Falls, Wisconsin, Forente stater, 53051
- Community Memorial Hospital
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Milwaukee, Wisconsin, Forente stater, 53226
- Medical College of Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53210
- St. Joseph's Hospital
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Milwaukee, Wisconsin, Forente stater, 53211
- Columbia Hospital
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Milwaukee, Wisconsin, Forente stater, 53215
- St. Luke's Medical Center
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Milwaukee, Wisconsin, Forente stater, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
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Racine, Wisconsin, Forente stater, 53405
- Southeastern Wisconsin Regional Cancer Center
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Waukesha, Wisconsin, Forente stater, 53188
- Waukesha Memorial Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
SYKDOMS KARAKTERISTIKA: Histologisk påvist nydiagnostisert, supratentorial glioblastoma multiforme (med områder med nekrose) Diagnosen må stilles ved kirurgisk biopsi eller eksisjon innen de siste 5 ukene Ingen tilbakevendende maligne gliomer Ingen metastaser under tentorium eller utover kraniehvelvet
PASIENT KARAKTERISTIKA: Alder: Voksen Ytelsesstatus: Karnofsky 70-100 % ELLER Zubrod 0-1 Forventet levealder: Minst 8 uker Hematopoetisk: Hemoglobin minst 10 g/dL (transfusjon tillatt) Hematokrit minst 30 % (transfusjon tillatt) Absolutt nøytrofil telle minst 1 500/mm3 Blodplateantall minst 100 000/mm3 Lever: Bilirubin ikke mer enn 2,0 mg/dL serumglutamat pyruvat transaminase (SGPT) eller serum glutamat oksaloacetat transaminase (SGOT) ikke mer enn 2 ganger blod ikke normalt ureal. større enn 25 mg/dL Kreatinin ikke mer enn 1,5 mg/dL Kardiovaskulær: Ingen aktiv tromboflebitt Annet: Gjenopprettet etter postoperativ infeksjon eller andre komplikasjoner Ingen alvorlige medisinske sykdommer eller psykiatriske funksjonsnedsettelser som vil utelukke studiedeltakelse Ingen aktiv bindevevsforstyrrelse, som lupus eller sklerodermi Ingen annen malignitet i løpet av de siste 5 årene bortsett fra ikke-melanomatøs hudkreft eller karsinom in situ av livmorhalsen eller blæren Ingen tidligere endometriekreft eller atypisk endometriehyperplasi Ingen AIDS Ikke gravid eller ammende Fertile pasienter må bruke effektiv prevensjon
FØR SAMTIDIG BEHANDLING: Biologisk terapi: Ikke spesifisert Kjemoterapi: Ikke spesifisert Endokrin terapi: Minst 12 måneder siden tidligere tamoxifen Strålebehandling: Se Sykdomskarakteristikker Ingen tidligere strålebehandling mot hode eller nakke Kirurgi: Se Sykdomskarakteristika Gjenopprettet etter tidligere operasjon
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Stråling pluss Tamoxifen
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Total overlevelse
Tidsramme: Fra registrering til dødsdato eller siste oppfølging. Analyse skjer etter at alle pasienter potensielt har blitt fulgt i 18 måneder.
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Fra registrering til dødsdato eller siste oppfølging. Analyse skjer etter at alle pasienter potensielt har blitt fulgt i 18 måneder.
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Robins HI, Won M, Seiferheld WF, Schultz CJ, Choucair AK, Brachman DG, Demas WF, Mehta MP. Phase 2 trial of radiation plus high-dose tamoxifen for glioblastoma multiforme: RTOG protocol BR-0021. Neuro Oncol. 2006 Jan;8(1):47-52. doi: 10.1215/S1522851705000311.
- Robins HI, Won M, Schultz C, et al.: A phase II trial of conventional radiation therapy (XRT) plus high dose tamoxifen (TAM) for the treatment of supratentorial glioblastoma multiforme (GBM): RTOG protocol BR-0021. [Abstract] J Clin Oncol 22 (Suppl 14): A-1529, 114s, 2004.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i nervesystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer, kjertel og epitel
- Astrocytom
- Glioma
- Neoplasmer, Neuroepithelial
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Glioblastom
- Neoplasmer i nervesystemet
- Neoplasmer i sentralnervesystemet
- Fysiologiske effekter av legemidler
- Antineoplastiske midler
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Hormonantagonister
- Bone Density Conservation Agents
- Østrogenantagonister
- Selektive østrogenreseptormodulatorer
- Østrogenreseptormodulatorer
- Tamoxifen
Andre studie-ID-numre
- RTOG-BR-0021
- CDR0000068266
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .