Stråleterapi med eller uden strålekirurgi til behandling af patienter med hjernemetastaser
18. november 2013 opdateret af: Radiation Therapy Oncology Group
ET FASE III FORSØG, DER SAMMENLIGNER HELHJERNEBEstråling MED VERSUS UDEN STEREOTAKTISK RADIOSIRURGI BOOST FOR PATIENTER MED EN TIL TRE URESEKTERET HJERNEMETASTASER
RATIONALE: Strålebehandling bruger højenergi-røntgenstråler til at beskadige tumorceller. Det vides endnu ikke, om det at give strålebehandling under operation er mere effektivt end standard strålebehandling til behandling af hjernemetastaser.
FORMÅL: Randomiseret fase III-forsøg til at sammenligne effektiviteten af strålebehandling med eller uden strålekirurgi til behandling af patienter med hjernemetastaser, som ikke kan fjernes under operationen.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
MÅL: I. Sammenlign den samlede overlevelse af patienter med én uopskæret hjernemetastase behandlet med konventionel strålebehandling af hele hjernen (WBRT) med versus uden et stereotaktisk strålekirurgi (SRS) boost. II. Sammenlign steder for tilbagefald og dødsårsag hos disse patienter behandlet med WBRT efterfulgt af SRS vs. WBRT alene.
OVERSIGT: Dette er en randomiseret, multicenter undersøgelse. Patienterne stratificeres efter center og ekstrakraniel sygdom (ja eller nej). Patienterne randomiseres til en af to behandlingsarme. Arm I: Patienter modtager fraktioneret ekstern stråle helhjernebestråling (WBRT) 5 dage hver uge i 3 uger. Begge portaler behandles under hver strålebehandlingssession. Patienter, der stadig har en solitær læsion med en diameter på højst 4,0 cm, modtager også stereotaktisk radiokirurgi inden for 7 dage efter at have afsluttet WBRT. Arm II: Patienter modtager kun WBRT. Patienterne følges hver 3. måned i 1 år, derefter hver 4. måned i 2 år og derefter årligt.
PROJEKTERET TILSLUTNING: I alt 262 patienter vil blive akkumuleret over 2,5-3,75 år til denne undersøgelse. Undersøgelsen kan lukke tidligt, hvis interimanalyse efter 33 % og 67 % af patienterne er blevet fulgt i 6 måneder giver signifikante resultater. Efter 14.06.99 vil der kun blive påløbet yderligere 46 patienter med en enkelt hjernemetastase.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
333
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
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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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- BC Cancer Agency
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New Brunswick
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Moncton, New Brunswick, Canada, E1C 8X3
- Doctor Leon Richard Oncology Centre
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Saint John, New Brunswick, Canada, E2L 4L2
- Saint John Regional Hospital
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Newfoundland and Labrador
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St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
- Newfoundland Cancer Treatment and Research Foundation
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Cancer Centre
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Ontario
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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 - General Campus
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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
- Centre Universitaire de Sante de l'Estrie - Site Fleurimont
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Montreal, Quebec, Canada, H2W 1S6
- McGill University Department of Oncology
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- University of Alabama Comprehensive Cancer Center
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Huntsville, Alabama, Forenede Stater, 35801
- Huntsville Hospital System
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Huntsville, Alabama, Forenede Stater, 35801
- Comprehensive Cancer Institute of Huntsville
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Mobile, Alabama, Forenede Stater, 36640
- Urology Associates - Mobile AL
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Mobile, Alabama, Forenede Stater, 36640-0460
- Mobile Infirmary Medical Center
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Mobile, Alabama, Forenede Stater, 36652
- MBCCOP - Gulf Coast
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Montgomery, Alabama, Forenede Stater, 36106-2801
- Alabama Oncology, LLC
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Tuscallosa, Alabama, Forenede Stater, 35401
- Radiation Oncology Associates of West Alabama
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Alaska
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Anchorage, Alaska, Forenede Stater, 99508
- Providence Cancer Therapy Center
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Arizona
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Tucson, Arizona, Forenede Stater, 85724
- Arizona Cancer Center
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California
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Concord, California, Forenede Stater, 94524-4110
- Mount Diablo Medical Center
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Fresno, California, Forenede Stater, 93720
- California Cancer Center
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Fresno, California, Forenede Stater, 93720
- Saint Agnes Cancer Center
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Glendale, California, Forenede Stater, 91204
- Glendale Memorial Hospital and Health Center
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Greenbrae, California, Forenede Stater, 94904
- Sutter Health Western Division Cancer Research Group
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La Jolla, California, Forenede Stater, 92093-0658
- University of California San Diego Cancer Center
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Loma Linda, California, Forenede Stater, 92354
- Loma Linda University Medical Center
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Long Beach, California, Forenede Stater, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, Forenede Stater, 90033-0800
- USC/Norris Comprehensive Cancer Center
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Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Forenede Stater, 91010
- Beckman Research Institute, City of Hope
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Los Angeles, California, Forenede Stater, 90027
- Kaiser Permanente Medical Center - Los Angeles
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Oakland, California, Forenede Stater, 94609-3305
- CCOP - Bay Area Tumor Institute
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Pomona, California, Forenede Stater, 91767
- Cancer Care Center
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Sacramento, California, Forenede Stater, 95816
- Radiation Oncology Center - Sacramento
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San Diego, California, Forenede Stater, 92101-1492
- Radiation Medical Group, Inc.
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San Francisco, California, Forenede Stater, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
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San Jose, California, Forenede Stater, 95128
- O'Connor Hospital
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Santa Rosa, California, Forenede Stater, 95403
- CCOP - Santa Rosa Memorial Hospital
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Stanford, California, Forenede Stater, 94305
- Stanford University
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80909
- Memorial Hospital Cancer Center
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Denver, Colorado, Forenede Stater, 80262
- University Of Colorado Cancer Center
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Connecticut
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Bridgeport, Connecticut, Forenede Stater, 06610
- Bridgeport Hospital
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Norwalk, Connecticut, Forenede Stater, 06856
- Whittingham Cancer Center
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Delaware
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Wilmington, Delaware, Forenede Stater, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20307-5000
- Walter Reed Army Medical Center
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Florida
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Clearwater, Florida, Forenede Stater, 33757-0210
- Lykes Center for Radiation Therapy
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Daytona Beach, Florida, Forenede Stater, 32114
- Halifax Medical Center
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Fort Myers, Florida, Forenede Stater, 33901
- Radiation Therapy Associates - Fort Myers
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Gainesville, Florida, Forenede Stater, 32610-0296
- University of Florida Health Science Center
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Melbourne, Florida, Forenede Stater, 32901
- Health First Holmes Regional Medical Center
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Miami, Florida, Forenede Stater, 33136
- Sylvester Cancer Center, University of Miami
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Miami, Florida, Forenede Stater, 33176-2197
- Baptist Hospital of Miami
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Miami, Florida, Forenede Stater, 33125
- Veterans Affairs Medical Center - Miami
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Miami Beach, Florida, Forenede Stater, 33140
- CCOP - Mount Sinai Medical Center
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Orange Park, Florida, Forenede Stater, 32073
- Florida Radiation Oncology Group
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Orlando, Florida, Forenede Stater, 32806
- MD Anderson Cancer Center Orlando
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Panama City, Florida, Forenede Stater, 32405-4587
- Gulf Coast Cancer Treatment Center
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Panama City, Florida, Forenede Stater, 32401
- Bay Medical Center
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Pensacola, Florida, Forenede Stater, 32514
- West Florida Cancer Institute - Pensacola
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Saint Petersburg, Florida, Forenede Stater, 33701
- Bayfront Medical Center
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Sarasota, Florida, Forenede Stater, 34233
- Sarasota Radiation and Medical Oncology Center
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Tallahassee, Florida, Forenede Stater, 32308
- Tallahassee Memorial HealthCare
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Tampa, Florida, Forenede Stater, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Emory University Hospital - Atlanta
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Atlanta, Georgia, Forenede Stater, 30342-1701
- CCOP - Atlanta Regional
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Columbus, Georgia, Forenede Stater, 31902
- Medical Center/John B. Amos Community Cancer Center
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Rome, Georgia, Forenede Stater, 30161
- InterCommunity Cancer Center at Rome
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Illinois
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Arlington Heights, Illinois, Forenede Stater, 60005
- Northwest Community Hospital
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern Memorial Hospital
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago Cancer Research Center
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Decatur, Illinois, Forenede Stater, 62526
- CCOP - Central Illinois
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Elgin, Illinois, Forenede Stater, 60123
- Provena St. Joseph Hospital- Regional Cancer Care Center
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Harvey, Illinois, Forenede Stater, 60426
- Ingalls Memorial Hospital
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Maywood, Illinois, Forenede Stater, 60153
- Loyola University Medical Center
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Park Ridge, Illinois, Forenede Stater, 60068
- Lutheran General Cancer Care Center
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Peoria, Illinois, Forenede Stater, 61636
- Methodist Medical Center of Illinois
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Indiana
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Anderson, Indiana, Forenede Stater, 46016
- St. John's Medical Center
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Indianapolis, Indiana, Forenede Stater, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
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Indianapolis, Indiana, Forenede Stater, 46206-1367
- Clarion Health Partners Inc.
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Indianapolis, Indiana, Forenede Stater, 46219
- Community Hospitals of Indianapolis - Regional Cancer Center
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Muncie, Indiana, Forenede Stater, 47303-3499
- Ball Memorial Hospital
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South Bend, Indiana, Forenede Stater, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Forenede Stater, 46617
- St. Joseph's Radiation Oncology Center
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Iowa
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Dubuque, Iowa, Forenede Stater, 52001
- Wendt Regional Cancer Center of Finley Hospital
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Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Hospitals and Clinics
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40511-1093
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, Forenede Stater, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
- James Graham Brown Cancer Center
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Louisville, Kentucky, Forenede Stater, 40215
- Louisville Radiation Oncology
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Madisonville, Kentucky, Forenede Stater, 42431
- Merle M. Mahr Cancer Center
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Paducah, Kentucky, Forenede Stater, 42001
- Western Baptist Hospital
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809
- Mary Bird Perkins Cancer Center
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Lafayette, Louisiana, Forenede Stater, 70501
- Romagosa Radiation Oncology Center
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New Orleans, Louisiana, Forenede Stater, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Forenede Stater, 70112
- MBCCOP - LSU Medical Center
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New Orleans, Louisiana, Forenede Stater, 70121
- CCOP - Ochsner
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Maine
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Portland, Maine, Forenede Stater, 04102
- Maine Medical Center
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Maryland
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Annapolis, Maryland, Forenede Stater, 21401
- Anne Arundel Oncology Center
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Baltimore, Maryland, Forenede Stater, 21225
- Sinai Hospital of Baltimore
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Baltimore, Maryland, Forenede Stater, 21204
- Greater Baltimore Medical Center and Cancer Center
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Baltimore, Maryland, Forenede Stater, 21225
- Harbor Hospital Center
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Baltimore, Maryland, Forenede Stater, 21237
- Radiation Oncology Affiliates of Maryland, P.A.
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Baltimore, Maryland, Forenede Stater, 21231
- Johns Hopkins Oncology Center
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Salisbury, Maryland, Forenede Stater, 21801
- Peninsula Regional Medical Center
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Massachusetts
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Hyannis, Massachusetts, Forenede Stater, 02601
- Cape Cod Hospital
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Jamaica Plain, Massachusetts, Forenede Stater, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Forenede Stater, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, Forenede Stater, 48201
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
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Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
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Flint, Michigan, Forenede Stater, 48432
- McLaren Regional Cancer Center
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Kalamazoo, Michigan, Forenede Stater, 49007-3731
- CCOP - Kalamazoo
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Lansing, Michigan, Forenede Stater, 48909
- Sparrow Regional Cancer Center
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Marquette, Michigan, Forenede Stater, 49855
- Marquette General Hospital
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Midland, Michigan, Forenede Stater, 48670
- MidMichigan Medical Center - Midland
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Royal Oak, Michigan, Forenede Stater, 48073
- William Beaumont Hospital
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Saginaw, Michigan, Forenede Stater, 48601
- St. Mary's Medical Center
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- CCOP - Metro-Minnesota
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Mississippi
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Tupelo, Mississippi, Forenede Stater, 38801
- North Mississippi Medical Center/Cancer Center
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Missouri
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Columbia, Missouri, Forenede Stater, 65203
- Ellis Fischel Cancer Center - Columbia
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Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Forenede Stater, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, Forenede Stater, 63110
- Mallinckrodt Institute of Radiology
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Springfield, Missouri, Forenede Stater, 65807
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Forenede Stater, 65807
- Cancer Research for the Ozarks
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Montana
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Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68114
- Methodist Cancer Center - Omaha
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Omaha, Nebraska, Forenede Stater, 68198-7400
- Nebraska Health System
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Norris Cotton Cancer Center
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Manchester, New Hampshire, Forenede Stater, 03103
- Elliot Regional Cancer Center
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New Jersey
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Camden, New Jersey, Forenede Stater, 08103
- Cooper Cancer Institute
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East Orange, New Jersey, Forenede Stater, 07018-1095
- Veterans Affairs Medical Center - East Orange
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Edison, New Jersey, Forenede Stater, 08818
- John F. Kennedy Medical Center
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Elizabeth, New Jersey, Forenede Stater, 07201
- Trinitas Hospital - Jersey Street Campus
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Long Branch, New Jersey, Forenede Stater, 07740
- Monmouth Medical Center
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Millville, New Jersey, Forenede Stater, 08332
- South Jersey Hospital - Millville
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Mount Holly, New Jersey, Forenede Stater, 08060
- Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
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New Brunswick, New Jersey, Forenede Stater, 08901
- Cancer Institute Of New Jersey
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Newark, New Jersey, Forenede Stater, 07112
- Newark Beth Israel Medical Center
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Pomona, New Jersey, Forenede Stater, 08240
- Atlantic City Medical Center
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Toms River, New Jersey, Forenede Stater, 08755
- Community Medical Center
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Trenton, New Jersey, Forenede Stater, 08629
- St. Francis Medical Center
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Warren, New Jersey, Forenede Stater, 07059
- Associated Radiologists, P.A.
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87102
- Saint Joseph Medical Center
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New York
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Albany, New York, Forenede Stater, 12208
- Cancer Center of Albany Medical Center
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Bronx, New York, Forenede Stater, 10461
- Albert Einstein Comprehensive Cancer Center
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Brooklyn, New York, Forenede Stater, 11203
- State University of New York Health Science Center at Brooklyn
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Brooklyn, New York, Forenede Stater, 11215-3609
- New York Methodist Hospital
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Buffalo, New York, Forenede Stater, 14263-0001
- Roswell Park Cancer Institute
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Clifton Springs, New York, Forenede Stater, 14432
- Finger Lakes Radiation Oncology, P.C.
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Manhasset, New York, Forenede Stater, 11030
- CCOP - North Shore University Hospital
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New York, New York, Forenede Stater, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Forenede Stater, 10003
- Beth Israel Medical Center
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New York, New York, Forenede Stater, 10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
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New York, New York, Forenede Stater, 10032
- Herbert Irving Comprehensive Cancer Center
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Plattsburgh, New York, Forenede Stater, 12901
- Champlain Valley Physicians Hospital Medical Center
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Poughkeepsie, New York, Forenede Stater, 12601
- Vassar Brothers Hospital
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Rochester, New York, Forenede Stater, 14642
- University of Rochester Cancer Center
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Valhalla, New York, Forenede Stater, 10595
- New York Medical College
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Concord, North Carolina, Forenede Stater, 28025
- Northeast Medical Center
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Greenville, North Carolina, Forenede Stater, 27858-4354
- East Carolina University School of Medicine
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Hickory, North Carolina, Forenede Stater, 28601
- Catawba Memorial Hospital
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Winston-Salem, North Carolina, Forenede Stater, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, Forenede Stater, 27157-1082
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
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North Dakota
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Fargo, North Dakota, Forenede Stater, 58122
- Meritcare Roger Maris Cancer Center
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Minot, North Dakota, Forenede Stater, 58701
- UNIMED Medical Center
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Ohio
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Akron, Ohio, Forenede Stater, 44302
- Akron General Medical Center
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Akron, Ohio, Forenede Stater, 44309
- Akron City Hospital
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Cincinnati, Ohio, Forenede Stater, 45219
- Christ Hospital
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Cleveland, Ohio, Forenede Stater, 44106
- University Hospitals of Cleveland
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Cleveland, Ohio, Forenede Stater, 44106-5065
- Ireland Cancer Center
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Columbus, Ohio, Forenede Stater, 43206
- CCOP - Columbus
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Columbus, Ohio, Forenede Stater, 43210
- Arthur G. James Cancer Hospital - Ohio State University
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Kettering, Ohio, Forenede Stater, 45429
- CCOP - Dayton
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Toledo, Ohio, Forenede Stater, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73101
- St. Anthony Hospital
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Tulsa, Oklahoma, Forenede Stater, 74104
- St. John Medical Center
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Oregon
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Portland, Oregon, Forenede Stater, 97213
- CCOP - Columbia River Program
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater, 18103
- Lehigh Valley Hospital
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Bethlehem, Pennsylvania, Forenede Stater, 18015
- St. Luke's Hospital Regional Cancer Center
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Danville, Pennsylvania, Forenede Stater, 17822-2001
- Geisinger Medical Center
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Darby, Pennsylvania, Forenede Stater, 19023
- Mercy Catholic Medical Center, Mercy Fitzgerald Divison
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Drexel Hill, Pennsylvania, Forenede Stater, 19026
- Delaware County Memorial Hospital
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Hershey, Pennsylvania, Forenede Stater, 17033
- Penn State Geisinger Cancer Center
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Philadelphia, Pennsylvania, Forenede Stater, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania Cancer Center
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Veterans Affairs Medical Center - Philadelphia
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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Philadelphia, Pennsylvania, Forenede Stater, 19141
- Albert Einstein Cancer Center
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Philadelphia, Pennsylvania, Forenede Stater, 19102-1192
- Hahnemann University Hospital
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Pittsburgh, Pennsylvania, Forenede Stater, 15224
- Western Pennsylvania Hospital
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University of Pittsburgh Cancer Institute
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Pittsburgh, Pennsylvania, Forenede Stater, 15219
- Mercy Hospital of Pittsburgh
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Reading, Pennsylvania, Forenede Stater, 19612-6052
- Reading Hospital and Medical Center
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Scranton, Pennsylvania, Forenede Stater, 18501
- Mercy Hospital Cancer Center - Scranton
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Wilkes-Barre, Pennsylvania, Forenede Stater, 18764
- Wilkes Barre General Hospital
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Wynnewood, Pennsylvania, Forenede Stater, 19096
- CCOP - MainLine Health
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York, Pennsylvania, Forenede Stater, 17315
- York Hospital
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02908-4735
- Roger Williams Medical Center/BUSM
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425-0721
- Medical University of South Carolina
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Greenville, South Carolina, Forenede Stater, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Forenede Stater, 29303
- CCOP - Upstate Carolina
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South Dakota
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Rapid City, South Dakota, Forenede Stater, 57709
- Rapid City Regional Hospital
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Tennessee
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Jackson, Tennessee, Forenede Stater, 38301
- Jackson-Madison County General Hospital
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Knoxville, Tennessee, Forenede Stater, 37901
- Baptist Regional Cancer Center - Knoxville
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Memphis, Tennessee, Forenede Stater, 38103
- University of Tennessee, Memphis Cancer Center
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Memphis, Tennessee, Forenede Stater, 38117
- CCOP - Baptist Cancer Institute
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Nashville, Tennessee, Forenede Stater, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Amarillo, Texas, Forenede Stater, 79106
- Harrington Cancer Center
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Beaumont, Texas, Forenede Stater, 77701
- Julie and Ben Rogers Cancer Institute
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Galveston, Texas, Forenede Stater, 77555-0209
- University of Texas Medical Branch
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Houston, Texas, Forenede Stater, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Lackland Air Force Base, Texas, Forenede Stater, 78236-5300
- Wilford Hall - 59th Medical Wing
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Lubbock, Texas, Forenede Stater, 79410-1894
- Joe Arrington Cancer Research and Treatment Center
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Pasadena, Texas, Forenede Stater, 77504
- Bayshore Medical Center
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Tyler, Texas, Forenede Stater, 75701
- East Texas Medical Center - Cancer Institute
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Utah
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Saint George, Utah, Forenede Stater, 84770
- Dixie Regional Medical Center
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Salt Lake City, Utah, Forenede Stater, 84132
- University of Utah Health Sciences Center
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Salt Lake City, Utah, Forenede Stater, 84143
- LDS Hospital
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Vermont
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Bennington, Vermont, Forenede Stater, 05201
- CCOP - Southwestern Vermont Regional Cancer Center
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Burlington, Vermont, Forenede Stater, 05401-3498
- Vermont Cancer Center
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Rutland, Vermont, Forenede Stater, 05701
- Green Mountain Oncology Group
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22901
- Martha Jefferson Hospital
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Charlottesville, Virginia, Forenede Stater, 22908
- Cancer Center, University of Virginia HSC
-
Harrisonburg, Virginia, Forenede Stater, 22801
- RMH Regional Canter Center
-
Lynchburg, Virginia, Forenede Stater, 24503
- Virginia Baptist Hospital
-
Portsmouth, Virginia, Forenede Stater, 23708-2197
- Naval Medical Center, Portsmouth
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98104
- Swedish Cancer Institute
-
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
-
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, 53226
- Medical College of Wisconsin
-
Milwaukee, Wisconsin, Forenede Stater, 53210
- St. Joseph's 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)
-
Racine, Wisconsin, Forenede Stater, 53405
- Southeastern Wisconsin Regional Cancer Center
-
Waukesha, Wisconsin, Forenede Stater, 53188
- Waukesha Memorial Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
SYGDOMSKARAKTERISTIKA: Ikke mere end 1 u-resektioneret eller subtotalt resekeret hjernemetastaselæsion fra histologisk bekræftet systemisk malignitet Kun kvalificeret, hvis kirurgisk resektion nægtes af patienten eller resektion vurderes upassende af patientens læge 1 intraparenkymal metastase MRI er klart defineret ved større diameter end læsion. 4,0 cm Ingen leukæmi eller lymfom Ekstrakranielle steder med primær metastatisk sygdom tilladt, hvis ingen kliniske eller radiografiske tegn på progression inden for 1 måned før indrejsen Ingen metastaser til hjernestammen, mellemhjernen, pons eller medulla Ingen leptomeningeal metastase ved MRI eller CSF-evaluering Ingen metastaser inden for 10 mm af optiske nerver og chiasme (området skal udelukkes fra højdosis stereotaktisk radiokirurgi boost-felt)
PATIENT KARAKTERISTIKA: Alder: 18 og derover Ydelsesstatus: 70-100% Karnofsky Hæmatopoietisk: Absolut neutrofiltal mindst 1.000/mm3 Trombocyttal mindst 50.000/mm3 Hæmoglobin mindst 8 g/dL Lever: Ikke specificeret: Ikke specificeret Nyre: Neurologisk status 0-2 Ingen større medicinsk eller psykiatrisk kontraindikation til protokolangivelse Fertile patienter skal bruge effektiv prævention
TIDLIGERE SAMTYDLIG BEHANDLING: Biologisk behandling: Ikke specificeret Kemoterapi: Ingen samtidig kemoterapi ved systemisk cancer Endokrin behandling: Samtidig hormonbehandling, inklusive tamoxifen, tilladt Strålebehandling: Ingen forudgående kraniel strålebehandling Kirurgi: Forudgående subtotal resektion tilladt Andet: Ingen anden samtidig behandling for hjernemetastaser indtil kl. tilbagevenden
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm 1
Helhjernestrålebehandling (WBRT) til 37,5 Gy/15 fraktioner/2,5
Gy en gang dagligt, 5 dage/uge efterfulgt af strålekirurgi til alle metastaser
|
|
|
Aktiv komparator: Arm 2
WBRT til 37,5 Gy/15 fraktioner/2,5
Gy en gang dagligt, 5 dage om ugen
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: David W. Andrews, MD, FACS, Sidney Kimmel Cancer Center at Thomas Jefferson University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Hazard LJ, Jensen RL, Shrieve DC. Role of stereotactic radiosurgery in the treatment of brain metastases. Am J Clin Oncol. 2005 Aug;28(4):403-10. doi: 10.1097/01.coc.0000158438.79665.bb.
- Andrews DW, Scott CB, Sperduto PW, Flanders AE, Gaspar LE, Schell MC, Werner-Wasik M, Demas W, Ryu J, Bahary JP, Souhami L, Rotman M, Mehta MP, Curran WJ Jr. Whole brain radiation therapy with or without stereotactic radiosurgery boost for patients with one to three brain metastases: phase III results of the RTOG 9508 randomised trial. Lancet. 2004 May 22;363(9422):1665-72. doi: 10.1016/S0140-6736(04)16250-8.
- Sperduto PW, Scott C, Andrews D: Stereotactic radiosurgery with whole brain radiation therapy improves survival in patients with brain metastases: report of Radiation Therapy Oncology Group phase III study 95-08. [Abstract] Int J Radiat Oncol Biol Phys 54(2 suppl 1): 3, 2002.
- Sperduto P, Scott C, Andrews D, et al.: Preliminary report of RTOG 95-08: a phase III trial comparing whole brain irradiation alone versus whole brain irradiation plus stereotactic radiosurgery for patients with two or three unresected brain metastases. [Abstract] Int J Radiat Oncol Biol Phys 48: A-6, 113, 2000.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 1996
Primær færdiggørelse (Faktiske)
1. januar 2002
Studieafslutning (Faktiske)
1. december 2004
Datoer for studieregistrering
Først indsendt
1. november 1999
Først indsendt, der opfyldte QC-kriterier
12. april 2004
Først opslået (Skøn)
13. april 2004
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. november 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. november 2013
Sidst verificeret
1. november 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RTOG-9508
- CDR0000064522
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 .