Hjernebestråling ved behandling af patienter med småcellet lungekræft i begrænset stadie
18. april 2016 opdateret af: Radiation Therapy Oncology Group
Et fase II randomiseret forsøg med to dosisskemaer til levering af profylaktisk kraniebestråling til patienter med begrænset sygdom småcellet lungekræft
RATIONALE: Strålebehandling bruger højenergi-røntgenstråler til at beskadige tumorceller. Det vides endnu ikke, hvilket strålebehandlingsregime der er mere effektivt til at forebygge hjernemetastaser hos patienter med småcellet lungekræft i begrænset stadie, samtidig med at der tages hensyn til kronisk neurotoksicitet fra strålebehandling.
FORMÅL: Dette randomiserede fase II-forsøg sammenligner forekomsten af kronisk neurotoksicitet mellem tre forskellige hjernebestrålingsregimer. Den tilsvarende fase III-komponent, der adresserer forebyggelse af hjernemetastaser, blev kørt af EORTC og rapporteret separat (NCT00005062).
Studieoversigt
Status
Status
Afsluttet
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
MÅL:
- Sammenlign forekomsten af kronisk neurotoksicitet hos patienter behandlet med disse regimer.
- Sammenlign livskvaliteten for patienter behandlet med disse regimer. (fase III lukket for periodisering pr. 31/12/05)
OVERSIGT: Dette er en randomiseret, multicenter undersøgelse. Patienterne er stratificeret efter alder (60 og under versus over 60) og tid siden induktionsbehandling (90 dage eller mindre vs 91-180 dage vs 181-240 dage). Patienterne randomiseres til 1 ud af 3 behandlingsarme.
- Arm I: Patienter gennemgår profylaktisk kraniel bestråling (PCI) en gang dagligt 5 dage om ugen. Behandlingen fortsætter i 2 uger i fravær af uacceptabel toksicitet.
- Arm II: Patienter gennemgår PCI én gang dagligt 5 dage om ugen. Behandlingen fortsætter i 2,6 uger i fravær af uacceptabel toksicitet.
- Arm III: Patienter gennemgår PCI to gange dagligt 5 dage om ugen. Behandlingen fortsætter i 3,4 uger i fravær af uacceptabel toksicitet.
Livskvalitet vurderes ved baseline, hver 6. måned i 1 år og derefter årligt i 3 år.
Patienterne følges hver 6. måned i 1 år og derefter årligt i 3 år.
PROJEKTERET TILSLUTNING: I alt 264 patienter vil blive akkumuleret til denne undersøgelse inden for 3,5 år.
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
265
Fase
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Montreal, Canada, H2W 1S6
- McGill Cancer Centre at McGill University
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal, Quebec, Canada, H2L 4M1
- Hopital Notre-Dame du CHUM
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Quebec City, Quebec, Canada, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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Arizona
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Phoenix, Arizona, Forenede Stater, 85013
- Arizona Oncology Services Foundation
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Scottsdale, Arizona, Forenede Stater, 85260
- Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
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Scottsdale, Arizona, Forenede Stater, 85251
- Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn
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Arkansas
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Springdale, Arkansas, Forenede Stater, 72764
- Highlands Oncology Group - Springdale
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California
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Auburn, California, Forenede Stater, 95603
- Auburn Radiation Oncology
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Cameron Park, California, Forenede Stater, 95682
- Radiation Oncology Centers - Cameron Park
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La Jolla, California, Forenede Stater, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Oakland, California, Forenede Stater, 94609
- CCOP - Bay Area Tumor Institute
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Pomona, California, Forenede Stater, 91767
- Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
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Roseville, California, Forenede Stater, 95661
- Radiation Oncology Center - Roseville
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Sacramento, California, Forenede Stater, 95815
- Radiological Associates of Sacramento Medical Group, Incorporated
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Sacramento, California, Forenede Stater, 95819
- Mercy General Hospital
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Vacaville, California, Forenede Stater, 95687
- Solano Radiation Oncology Center
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80909
- Memorial Hospital Cancer Center - Colorado Springs
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Grand Junction, Colorado, Forenede Stater, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Delaware
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Lewes, Delaware, Forenede Stater, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, Forenede Stater, 19713
- CCOP - Christiana Care Health Services
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Florida
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Gainesville, Florida, Forenede Stater, 32610-0232
- University of Florida Shands Cancer Center
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Miami, Florida, Forenede Stater, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, Forenede Stater, 33176
- Baptist-South Miami Regional Cancer Program
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Panama City, Florida, Forenede Stater, 32401
- Bay Medical
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Georgia
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Gainesville, Georgia, Forenede Stater, 30501
- Northeast Georgia Medical Center
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Illinois
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Arlington Heights, Illinois, Forenede Stater, 60005
- Northwest Community Hospital
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Aurora, Illinois, Forenede Stater, 60507
- Rush-Copley Cancer Care Center
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Bloomington, Illinois, Forenede Stater, 61701
- St. Joseph Medical Center
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Canton, Illinois, Forenede Stater, 61520
- Graham Hospital
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Carthage, Illinois, Forenede Stater, 62321
- Memorial Hospital
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Effingham, Illinois, Forenede Stater, 62401
- St. Anthony's Memorial Hospital
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Eureka, Illinois, Forenede Stater, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Forenede Stater, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, Forenede Stater, 61401
- Galesburg Clinic, PC
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Galesburg, Illinois, Forenede Stater, 61401
- InterCommunity Cancer Center of Western Illinois
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Havana, Illinois, Forenede Stater, 62644
- Mason District Hospital
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Hopedale, Illinois, Forenede Stater, 61747
- Hopedale Medical Complex
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Joliet, Illinois, Forenede Stater, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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Kewanee, Illinois, Forenede Stater, 61443
- Kewanee Hospital
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La Grange, Illinois, Forenede Stater, 60525
- La Grange Memorial Hospital
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Macomb, Illinois, Forenede Stater, 61455
- Mcdonough District Hospital
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Maywood, Illinois, Forenede Stater, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Normal, Illinois, Forenede Stater, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Forenede Stater, 61761
- Community Cancer Center
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Ottawa, Illinois, Forenede Stater, 61350
- Community Hospital of Ottawa
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Pekin, Illinois, Forenede Stater, 61554
- Cancer Treatment Center at Pekin Hospital
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Peoria, Illinois, Forenede Stater, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Forenede Stater, 61614
- Proctor Hospital
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Peoria, Illinois, Forenede Stater, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Forenede Stater, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Forenede Stater, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Forenede Stater, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Forenede Stater, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, Forenede Stater, 61362
- St. Margaret's Hospital
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Spring Valley, Illinois, Forenede Stater, 61362
- Valley Cancer Center
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Urbana, Illinois, Forenede Stater, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, Forenede Stater, 61801
- CCOP - Carle Cancer Center
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Indiana
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Anderson, Indiana, Forenede Stater, 46016
- Saint John's Cancer Center at Saint John's Medical Center
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Fort Wayne, Indiana, Forenede Stater, 46805
- Parkview Regional Cancer Center at Parkview Health
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Indianapolis, Indiana, Forenede Stater, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Forenede Stater, 46202
- Veterans Affairs Medical Center - Indianapolis
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La Porte, Indiana, Forenede Stater, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Michigan City, Indiana, Forenede Stater, 46360
- Saint Anthony Memorial Health Centers
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Muncie, Indiana, Forenede Stater, 47303-3499
- Cancer Center at Ball Memorial Hospital
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South Bend, Indiana, Forenede Stater, 46601
- Memorial Hospital of South Bend
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Iowa
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Ames, Iowa, Forenede Stater, 50010
- McFarland Clinic, PC
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Iowa City, Iowa, Forenede Stater, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kansas
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Chanute, Kansas, Forenede Stater, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Forenede Stater, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Forenede Stater, 67042
- Cancer Center of Kansas, PA - El Dorado
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Kingman, Kansas, Forenede Stater, 67068
- Cancer Center of Kansas, PA - Kingman
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Liberal, Kansas, Forenede Stater, 67901
- Southwest Medical Center
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Newton, Kansas, Forenede Stater, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Forenede Stater, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Forenede Stater, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Forenede Stater, 67042
- Cancer Center of Kansas, PA - Salina
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Topeka, Kansas, Forenede Stater, 66606
- Cotton-O'Neil Cancer Center
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Topeka, Kansas, Forenede Stater, 66606
- St. Francis Comprehensive Cancer Center
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Wellington, Kansas, Forenede Stater, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Forenede Stater, 67214
- Wesley Medical Center
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Wichita, Kansas, Forenede Stater, 67203
- Associates in Womens Health, PA - North Review
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Wichita, Kansas, Forenede Stater, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Forenede Stater, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Forenede Stater, 67214
- CCOP - Wichita
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Wichita, Kansas, Forenede Stater, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Winfield, Kansas, Forenede Stater, 67156
- Cancer Center of Kansas, PA - Winfield
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Elkton MD, Maryland, Forenede Stater, 21921
- Union Hospital Cancer Program at Union Hospital
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- Boston University Cancer Research Center
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Fall River, Massachusetts, Forenede Stater, 02721
- Hudner Oncology Center at Saint Anne's Hospital - Fall River
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Quincy, Massachusetts, Forenede Stater, 02169
- South Suburban Oncology Center
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Michigan
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Adrian, Michigan, Forenede Stater, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Forenede Stater, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor, Michigan, Forenede Stater, 48109-0942
- University Of Michigan Comprehensive Cancer Center
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Battle Creek, Michigan, Forenede Stater, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, Forenede Stater, 49307
- Mecosta County Medical Center
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Detroit, Michigan, Forenede Stater, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Detroit, Michigan, Forenede Stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Grand Rapids, Michigan, Forenede Stater, 49503
- Butterworth Hospital at Spectrum Health
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Grand Rapids, Michigan, Forenede Stater, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Forenede Stater, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grand Rapids, Michigan, Forenede Stater, 49506
- Metro Health Hospital
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Holland, Michigan, Forenede Stater, 49423
- Holland Community Hospital
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Kalamazoo, Michigan, Forenede Stater, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Forenede Stater, 49001
- Borgess Medical Center
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Kalamazoo, Michigan, Forenede Stater, 49007-3731
- West Michigan Cancer Center
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Muskegon, Michigan, Forenede Stater, 49442
- Hackley Hospital
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St. Joseph, Michigan, Forenede Stater, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Traverse City, Michigan, Forenede Stater, 49684
- Munson Medical Center
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Minnesota
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Mankato, Minnesota, Forenede Stater, 56002
- Immanuel St. Joseph's
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St. Cloud, Minnesota, Forenede Stater, 56303
- CentraCare Clinic - River Campus
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Mississippi
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Pascagoula, Mississippi, Forenede Stater, 39581
- Regional Cancer Center at Singing River Hospital
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Missouri
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Cape Girardeau, Missouri, Forenede Stater, 63703
- Cancer Institute of Cape Girardeau, LLC
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St. Louis, Missouri, Forenede Stater, 63141
- CCOP - St. Louis-Cape Girardeau
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89102
- University Medical Center of Southern Nevada
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Las Vegas, Nevada, Forenede Stater, 89106
- CCOP - Nevada Cancer Research Foundation
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Reno, Nevada, Forenede Stater, 89509
- Radiation Oncology Associates - Reno
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New Jersey
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Brick, New Jersey, Forenede Stater, 08724
- Ocean Medical Center at Meridian Health
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Edison, New Jersey, Forenede Stater, 08818
- John F. Kennedy Medical Center
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Long Branch, New Jersey, Forenede Stater, 07740-6395
- Monmouth Medical Center
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Marlton, New Jersey, Forenede Stater, 08053
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
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Red Bank, New Jersey, Forenede Stater, 07701
- Booker Cancer Center at Riverview Medical Center
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Sparta, New Jersey, Forenede Stater, 07871
- Frederick R. and Betty M. Smith Cancer Treatment Center
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Toms River, New Jersey, Forenede Stater, 08755
- J. Phillip Citta Regional Cancer Center at Community Medical Center
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Vineland, New Jersey, Forenede Stater, 08360
- Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
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Voorhees, New Jersey, Forenede Stater, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New York
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Buffalo, New York, Forenede Stater, 14263-0001
- Roswell Park Cancer Institute
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Middletown, New York, Forenede Stater, 10940-4199
- Tucker Center for Cancer Care at Orange Regional Medical Center
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Poughkeepsie, New York, Forenede Stater, 12601
- Hudson Valley Oncology Associates
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Rochester, New York, Forenede Stater, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Rochester, New York, Forenede Stater, 14620
- Highland Hospital of Rochester
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Syracuse, New York, Forenede Stater, 13210
- SUNY Upstate Medical University Hospital
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
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Goldsboro, North Carolina, Forenede Stater, 27534
- Wayne Radiation Oncology
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Goldsboro, North Carolina, Forenede Stater, 27534
- Wayne Memorial Hospital, Incorporated
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Greenville, North Carolina, Forenede Stater, 27835-6028
- Leo W. Jenkins Cancer Center at ECU Medical School
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Kinston, North Carolina, Forenede Stater, 28501
- Kinston Medical Specialists
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Statesville, North Carolina, Forenede Stater, 28677
- Iredell Memorial Hospital
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Ohio
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Akron, Ohio, Forenede Stater, 44309-2090
- Summa Center for Cancer Care at Akron City Hospital
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Canton, Ohio, Forenede Stater, 44710-1799
- Aultman Cancer Center at Aultman Hospital
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Cincinnati, Ohio, Forenede Stater, 45267
- Charles M. Barrett Cancer Center at University Hospital
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Forenede Stater, 44112
- Huron Hospital Cancer Care Center
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Cleveland, Ohio, Forenede Stater, 44119
- Euclid Hospital
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Lima, Ohio, Forenede Stater, 45804
- Lima Memorial Hospital
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Lima, Ohio, Forenede Stater, 45801
- St. Rita's Medical Center
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Mansfield, Ohio, Forenede Stater, 44903
- MedCentral - Mansfield Hospital
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Maumee, Ohio, Forenede Stater, 43537
- St. Luke's Hospital
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Mayfield Heights, Ohio, Forenede Stater, 44124
- Hillcrest Cancer Center at Hillcrest Hospital
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Oregon, Ohio, Forenede Stater, 43616
- St. Charles Mercy Hospital
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Salem, Ohio, Forenede Stater, 44460
- Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
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Sandusky, Ohio, Forenede Stater, 44870
- Firelands Regional Medical Center
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Sylvania, Ohio, Forenede Stater, 43560
- Flower Hospital Cancer Center
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Tiffin, Ohio, Forenede Stater, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Forenede Stater, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, Forenede Stater, 43606
- Toledo Hospital
-
Toledo, Ohio, Forenede Stater, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, Forenede Stater, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, Forenede Stater, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Warrensville Heights, Ohio, Forenede Stater, 44122
- South Pointe Hospital Cancer Care Center
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Wooster, Ohio, Forenede Stater, 44691
- Cancer Treatment Center
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Oregon
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Grants Pass, Oregon, Forenede Stater, 97527
- Three Rivers Community Hospital
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Gresham, Oregon, Forenede Stater, 97030
- Legacy Mount Hood Medical Center
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Medford, Oregon, Forenede Stater, 97504
- Dubs Cancer Center at Rogue Valley Medical Center
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Medford, Oregon, Forenede Stater, 97504
- Providence Cancer Center at PMCC
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Milwaukie, Oregon, Forenede Stater, 97222
- Providence Milwaukie Hospital
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Portland, Oregon, Forenede Stater, 97210
- Legacy Good Samaritan Hospital & Comprehensive Cancer Center
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Portland, Oregon, Forenede Stater, 97213-2967
- Providence Cancer Center at Providence Portland Medical Center
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Portland, Oregon, Forenede Stater, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, Forenede Stater, 97225
- Providence St. Vincent Medical Center
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Portland, Oregon, Forenede Stater, 97227
- Legacy Emanuel Hospital and Health Center and Children's Hospital
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Tualatin, Oregon, Forenede Stater, 97062
- Legacy Meridian Park Hospital
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Pennsylvania
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Abington, Pennsylvania, Forenede Stater, 19001
- Rosenfeld Cancer Center at Abington Memorial Hospital
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Bethlehem, Pennsylvania, Forenede Stater, 18015
- St. Luke's Cancer Network at St. Luke's Hospital
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East Stroudsburg, Pennsylvania, Forenede Stater, 18301
- Dale and Frances Hughes Cancer Center at Pocono Medical Center
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Hershey, Pennsylvania, Forenede Stater, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Forenede Stater, 19111-2497
- Fox Chase Cancer Center - Philadelphia
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Philadelphia, Pennsylvania, Forenede Stater, 19141
- Albert Einstein Cancer Center
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Philadelphia, Pennsylvania, Forenede Stater, 19107-5541
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
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Philadelphia, Pennsylvania, Forenede Stater, 19140
- Fox Chase Cancer Center CCOP Research Base
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Reading, Pennsylvania, Forenede Stater, 19612-6052
- McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
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York, Pennsylvania, Forenede Stater, 17405
- York Cancer Center at Apple Hill Medical Center
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Greenville, South Carolina, Forenede Stater, 29615
- CCOP - Greenville
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South Dakota
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Rapid City, South Dakota, Forenede Stater, 57701
- Rapid City Regional Hospital
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Texas
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Arlington, Texas, Forenede Stater, 76012-2510
- Arlington Cancer Center - Arlington
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Dallas, Texas, Forenede Stater, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Houston, Texas, Forenede Stater, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
-
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Utah
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Murray, Utah, Forenede Stater, 84107
- Cottonwood Hospital Medical Center
-
Murray, Utah, Forenede Stater, 84157
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
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Ogden, Utah, Forenede Stater, 84403
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
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Provo, Utah, Forenede Stater, 84604
- Utah Valley Regional Medical Center - Provo
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Saint George, Utah, Forenede Stater, 84770
- Dixie Regional Medical Center - East Campus
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Salt Lake City, Utah, Forenede Stater, 84143
- LDS Hospital
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Salt Lake City, Utah, Forenede Stater, 84106
- Utah Cancer Specialists at UCS Cancer Center
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Washington
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Bellingham, Washington, Forenede Stater, 98225
- St. Joseph Cancer Center
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Bremerton, Washington, Forenede Stater, 98310
- Harrison Medical Center
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Seattle, Washington, Forenede Stater, 98104
- Harborview Medical Center
-
Seattle, Washington, Forenede Stater, 98104
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, Forenede Stater, 98112
- Group Health Central Hospital
-
Seattle, Washington, Forenede Stater, 98122-4307
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
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Seattle, Washington, Forenede Stater, 98195-6043
- University Cancer Center at University of Washington Medical Center
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Spokane, Washington, Forenede Stater, 99202
- Cancer Care Northwest - Spokane South
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Tacoma, Washington, Forenede Stater, 98431
- Madigan Army Medical Center - Tacoma
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Vancouver, Washington, Forenede Stater, 98668
- Southwest Washington Medical Center Cancer Center
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Wenatchee, Washington, Forenede Stater, 98801-2028
- Wenatchee Valley Medical Center
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West Virginia
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Wheeling, West Virginia, Forenede Stater, 26003
- Schiffler Cancer Center at Wheeling Hospital
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Wisconsin
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Green Bay, Wisconsin, Forenede Stater, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Forenede Stater, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Forenede Stater, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
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Green Bay, Wisconsin, Forenede Stater, 54303
- St. Mary's Hospital Medical Center - Green Bay
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La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
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Marinette, Wisconsin, Forenede Stater, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin Cancer Center
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Milwaukee, Wisconsin, Forenede Stater, 53295
- Veterans Affairs Medical Center - Milwaukee
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Oconomowoc, Wisconsin, Forenede Stater, 53066
- Regional Cancer Center at Oconomowoc Memorial Hospital
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Racine, Wisconsin, Forenede Stater, 53405
- All Saints Cancer Center at Wheaton Franciscan Healthcare
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Waukesha, Wisconsin, Forenede Stater, 53188
- Waukesha Memorial Hospital Regional Cancer Center
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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
Berettigelseskriterier
Aldre berettiget til at studere
Ikke ældre end 120 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
SYGDOMS KARAKTERISTIKA:
Histologisk eller cytologisk bekræftet småcellet lungekræft ved finnålsaspiration, biopsi eller 2 positive sputa
Begrænset trin (I-IIIB)
- Begrænset til 1 hemithorax
- Ingen T4 baseret på ondartet pleural effusion eller N3 sygdom baseret på kontralateral hilar eller kontralateral supraklavikulær involvering
- Fuldstændig respons efter induktionskemoterapi (med eller uden thoraxstrålebehandling)
- Konsolidativ thoraxstrålebehandling kan påbegyndes før undersøgelsen
Ingen røntgenbevis for nogen af følgende:
Hjernemetastaser
- Normal hjerne CT-scanning eller MR mindre end 1 måned før undersøgelse
- Ipsilaterale lungemetastaser
Ondartet pleural effusion
- Minimal pleuraeffusion ved CT-scanning af thorax er tilladt, men ikke ved røntgen af thorax
PATIENT KARAKTERISTIKA:
Alder
- Ikke specificeret
Præstationsstatus
- Zubrod 0-1
Forventede levealder
- Ikke specificeret
Hæmatopoietisk
- Absolut granulocyttal mindst 1.500/mm^3
- Blodpladetal mindst 75.000/mm^3
- Hæmoglobin mindst 10,0 g/dL^
Hepatisk
- Ikke specificeret
Renal
- Ikke specificeret
Pulmonal
- Se Sygdomskarakteristika
Andet
- Ikke gravid eller ammende
- Fertile patienter skal bruge effektiv prævention
- Neurologisk funktionsklasse 1 eller 2
- Ingen epilepsi, der kræver permanent oral medicin
- Ingen anden malignitet inden for de seneste 5 år undtagen ikke-melanom hudkræft eller carcinom in situ i livmoderhalsen
- Ingen anden alvorlig medicinsk eller psykiatrisk tilstand, der ville udelukke studiedeltagelse
FORUDSÆTNING SAMTYDLIG TERAPI:
Biologisk terapi
- Ikke specificeret
Kemoterapi
- Se Sygdomskarakteristika
- Mindst 1 uge siden forudgående kemoterapi
- Ingen samtidig kemoterapi
Endokrin terapi
- Ikke specificeret
Strålebehandling
- Se Sygdomskarakteristika
- Ingen tidligere ekstern strålebehandling af hoved eller nakke, inklusive stereotaktisk strålebehandling
- Samtidig thoraxstrålebehandling tilladt
Kirurgi
- Ikke specificeret
Andet
- Ingen samtidige antitumormidler
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)
Antal våben
3
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Aktiv komparator: Arm I
Profylaktisk kraniebestråling, 2,5 Gy fx
|
Profylaktisk kraniebestråling, 2,5 Gy én gang dagligt, M-F, i 10 fraktioner (fx) i alt 25 Gy
Andre navne:
|
|
Eksperimentel: Arm II
Profylaktisk kraniebestråling, 2,0 Gy fx
|
Profylaktisk kraniebestråling, 2,0 Gy én gang dagligt, M-F, i 18 fraktioner (fx) i alt 36 Gy
Andre navne:
|
|
Eksperimentel: Arm III
Profylaktisk kraniebestråling, 1,5 Gy fx
|
Profylaktisk kraniebestråling, 1,5 Gy to gange dagligt, M-F, i 24 fraktioner (fx) til en samlet dosis på 36 Gy
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Forekomst af kronisk neurotoksicitet
Tidsramme: Fra studietilmelding til et år.
|
Kronisk neurotoksicitet er defineret som et fald i en standard målefejl (SEM) i en af de tre test, der omfatter det neuropsykologiske testbatteri (Hopkins Verbal Learning Test, Controlled Word Association Test og Trail-Making Test) uden udvikling af hjernemetastase med et år.
SEM beregnes som standardafvigelsen af baseline-testen ganget med kvadratroden af én minus den offentliggjorte reliabilitetskoefficient for testen.
|
Fra studietilmelding til et år.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Studiestol: Aaron H. Wolfson, MD, University of Miami Sylvester Comprehensive Cancer Center
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
- Le Pechoux C, Dunant A, Senan S, Wolfson A, Quoix E, Faivre-Finn C, Ciuleanu T, Arriagada R, Jones R, Wanders R, Lerouge D, Laplanche A; Prophylactic Cranial Irradiation (PCI) Collaborative Group. Standard-dose versus higher-dose prophylactic cranial irradiation (PCI) in patients with limited-stage small-cell lung cancer in complete remission after chemotherapy and thoracic radiotherapy (PCI 99-01, EORTC 22003-08004, RTOG 0212, and IFCT 99-01): a randomised clinical trial. Lancet Oncol. 2009 May;10(5):467-74. doi: 10.1016/S1470-2045(09)70101-9. Epub 2009 Apr 20.
- Pechoux CL, Hatton M, Kobierska A, et al.: Randomized trial of standard dose to a higher dose prophylactic cranial irradiation (PCI) in limited-stage small cell cancer (SCLC) complete responders (CR): primary endpoint analysis (PCI99-01, IFCT 99-01, EORTC 22003-08004, RTOG 0212). [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA7514, 2008.
- Gondi V, Paulus R, Bruner D, et al.: Prognostic significance of QOL deterioration during early lung cancer survivorship: secondary analysis of RTOG 0212 and 0214. [Abstract] J Clin Oncol 29 (Suppl 15): A-6061, 2011.
- Wolfson AH, Bae K, Komaki R, Meyers C, Movsas B, Le Pechoux C, Werner-Wasik M, Videtic GM, Garces YI, Choy H. Primary analysis of a phase II randomized trial Radiation Therapy Oncology Group (RTOG) 0212: impact of different total doses and schedules of prophylactic cranial irradiation on chronic neurotoxicity and quality of life for patients with limited-disease small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):77-84. doi: 10.1016/j.ijrobp.2010.05.013. Epub 2010 Aug 26.
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
Studiestart
1. februar 2003
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
1. maj 2009
Studieafslutning (Faktiske)
Studieafslutning
1. november 2013
Datoer for studieregistrering
Først indsendt
Først indsendt
7. april 2003
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
8. april 2003
Først opslået (Skøn)
Først opslået
9. april 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
25. maj 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. april 2016
Sidst verificeret
Sidst verificeret
1. april 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- RTOG-0212
- CDR0000258668
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 .