Stråleterapi til behandling af patienter med trin II eller trin III prostatakræft
8. januar 2020 opdateret af: Radiation Therapy Oncology Group
ET FASE I/II DOSESEKALATIONSUNDERSØGELSE, DER BRUGER TREDIMENSIONEL KONFORMAL STRÅLETERAPI TIL ADENOCARCINOMA I PROSTAA
RATIONALE: Strålebehandling bruger højenergi-røntgenstråler til at beskadige tumorceller og kan være en effektiv behandling af prostatakræft.
FORMÅL: Fase I/II forsøg til undersøgelse af effektiviteten af strålebehandling til behandling af patienter, der tidligere har ubehandlet stadium II eller stadium III prostatacancer.
Studieoversigt
Detaljeret beskrivelse
MÅL: I. Bestem den maksimalt tolererede dosis af 3-dimensionel konform strålebehandling til prostatakirtlen og umiddelbart omkringliggende væv hos patienter med stadium II eller III adenocarcinom i prostata. II. Bestem den normale vævstoksicitetsrate for denne kur i endetarmen og blæren hos disse patienter. III. Bestem lokal kontrol ved klinisk og patologisk undersøgelse og ved PSA-bestemmelser hos patienter behandlet med dette regime. IV. Bestem fjernsvigt og overordnet overlevelse for patienter behandlet med dette regime.
OVERSIGT: Dette er en dosiseskaleringsundersøgelse. Patienterne er stratificeret efter 1 af følgende 3 prognostiske grupper: Gruppe 1: T1b-c eller T2a-b med kombineret PSA/Gleason (CPG) score 15 og under gruppe 2: T1b-c eller T2a-b med CPG score mere end 15 eller enhver T2c med PSA mindre end 70 ng/ml Gruppe 3: T3 med prostataspecifikt antigen (PSA) mindre end 70 ng/ml Patienter modtager 3-dimensionel (3-D) konform strålebehandling 5 dage om ugen i 7,6, 8,2 eller 8,8 uger. Kohorter på 120-270 patienter modtager eskalerende doser af 3-D konform strålebehandling, indtil den maksimalt tolererede dosis (MTD) er bestemt. MTD er defineret som den dosis, der går forud for den, hvor 20 % af patienterne oplever dosisbegrænsende toksicitet. Patienterne følges hver 3. måned i 1 år, hver 4. måned i 1 år, hver 6. måned i 3 år og derefter årligt.
PROJEKTERET OPSÆTNING: I alt 549-801 patienter (120-204 patienter for det første dosisniveau, 237-321 patienter for det andet dosisniveau og 192-276 patienter for det tredje dosisniveau) vil blive akkumuleret til denne undersøgelse inden for 4,75 til 5,25 år.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1084
Fase
- Fase 2
- Fase 1
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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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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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, K1Y 4K7
- Ottawa Regional Cancer Centre - Civic 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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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
- Comprehensive Cancer Institute of Huntsville
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Mobile, Alabama, Forenede Stater, 36688
- MBCCOP - University of South Alabama
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Mobile, Alabama, Forenede Stater, 36640-0460
- Mobile Infirmary Medical Center
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Montgomery, Alabama, Forenede Stater, 36106-2801
- Alabama Oncology, LLC
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Tuscaloosa, Alabama, Forenede Stater, 35401
- Radiation Oncology Associates of West Alabama
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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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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 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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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 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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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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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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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, 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, 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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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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Marquette, Michigan, Forenede Stater, 49855
- Marquette General Hospital
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Midland, Michigan, Forenede Stater, 48670
- MidMichigan Regional Medical Center
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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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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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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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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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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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Newark, New Jersey, Forenede Stater, 07112
- Newark Beth Israel 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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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
- Kaplan 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, 44195
- Cleveland Clinic Cancer Center
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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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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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Danville, Pennsylvania, Forenede Stater, 17822-2001
- Penn State 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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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, 38117
- CCOP - Baptist Cancer Institute
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Memphis, Tennessee, Forenede Stater, 38163
- University of Tennessee, Memphis Cancer Center
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Nashville, Tennessee, Forenede Stater, 37232-6838
- Vanderbilt 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, 77555-1329
- University of Texas Medical Branch
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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, 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
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Lynchburg, Virginia, Forenede Stater, 24503
- Virginia Baptist Hospital
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Portsmouth, Virginia, Forenede Stater, 23708-2197
- Naval Medical Center, Portsmouth
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Washington
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Seattle, Washington, Forenede Stater, 98104
- Swedish Cancer Institute
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Seattle, Washington, Forenede Stater, 98111
- Virginia Mason Medical Center
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Spokane, Washington, Forenede Stater, 99210-0248
- Deaconess Medical Center
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Yakima, Washington, Forenede Stater, 98902
- Yakima Valley Memorial Hospital
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West Virginia
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Wheeling, West Virginia, Forenede Stater, 26003
- Schiffler Cancer Center
-
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Wisconsin
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Green Bay, Wisconsin, Forenede Stater, 54307-3508
- St. Vincent Hospital
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La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Medical Foundation
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Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin Comprehensive Cancer Center
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Madison, Wisconsin, Forenede Stater, 53713
- Southern Wisconsin Radiotherapy Center
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Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Clinic
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Menomonee Falls, Wisconsin, Forenede Stater, 53051
- Community Memorial Hospital
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53210
- St. Joseph's Hospital
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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)
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Racine, Wisconsin, Forenede Stater, 53405
- Southeastern Wisconsin Regional Cancer Center
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Waukesha, Wisconsin, Forenede Stater, 53188
- Waukesha Memorial Hospital
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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
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
SYGDOMSKARAKTERISTIKA: Tidligere ubehandlet adenocarcinom i prostata T1b-c eller T2a-b med en Gleason-score på mere end 5 og PSA større end 4 ng/ml ELLER Enhver T3 PSA under 70 ng/ml inden for 3 uger før indtræden og mindst 10 dage efter prostatabiopsi Ingen biopsi påvist regional knudepåvirkning Ingen fjernmetastaser
PATIENT KARAKTERISTIKA: Alder: 18 og derover Ydelsesstatus: Karnofsky 80-100 % hæmatopoietisk: Antal hvide blodlegemer (WBC) på mindst 4.000/mm3 Trombocyttal mindst 100.000/mm3 Hæmoglobin mindst 11 g/dL Nyre: Ikke specificeret. : Ikke specificeret Andet: Ingen større medicinsk eller psykiatrisk sygdom, der ville udelukke undersøgelse. Ingen anden malignitet inden for de seneste 5 år
TIDLIGERE SAMTYDENDE BEHANDLING: Biologisk terapi: Ikke specificeret Kemoterapi: Ingen forudgående eller samtidig kemoterapi Endokrin terapi: Tidligere hormonbehandling tilladt Strålebehandling: Ingen tidligere bækkenbestråling Kirurgi: Ingen forudgående prostatektomi eller kryokirurgi for prostatacancer
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: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Gruppe 1
Kliniske stadier T1b-c eller T2a-b med PSA + ([Gleason -6] x 10) er ≤ 15.
Eskalerende doser af tredimensionel konform strålebehandling (3D-CRT), indtil den maksimalt tolererede dosis (MTD) er etableret.
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3 dimensionel konform strålebehandling
Andre navne:
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Eksperimentel: Gruppe 2
Kliniske stadier T1b-c eller T2a-b med PSA + ([Gleason -6]x10)>15.
Enhver klinisk T2c med PSA < 70.
Skal være lymfeknude negativ.
Eskalerende doser af tredimensionel konform strålebehandling (3D-CRT), indtil den maksimalt tolererede dosis (MTD) er etableret.
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3 dimensionel konform strålebehandling
Andre navne:
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Eksperimentel: Gruppe 3
Klinisk stadium T3 med PSA < 70.
Skal være lymfeknude negativ.
Eskalerende doser af tredimensionel konform strålebehandling (3D-CRT), indtil den maksimalt tolererede dosis (MTD) er etableret.
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3 dimensionel konform strålebehandling
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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At fastlægge den maksimalt tolererede dosis (MTD) af stråling, der kan leveres til prostatakirtlen og det umiddelbare omgivende væv hos patienter med carcinom i prostata ved brug af tredimensionel konform strålebehandling (3D-CRT).
Tidsramme: Fra registrering til cirka 18 måneder fra behandlingsstart
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Fra registrering til cirka 18 måneder fra behandlingsstart
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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At kvantificere den normale vævstoksicitet (normal vævskomplikationssandsynlighed (NTCP)) for rektum og blære ved hjælp af 3D-CRT
Tidsramme: Fra registrering til cirka 18 måneder fra behandlingsstart
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Fra registrering til cirka 18 måneder fra behandlingsstart
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At evaluere lokal kontrol ved kliniske, patologiske og PSA (stabile i normalområdet) bestemmelser
Tidsramme: Fra registrering til dato for progression eller sidste opfølgning. Analyse vil finde sted efter den primære endepunktsanalyse.
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Fra registrering til dato for progression eller sidste opfølgning. Analyse vil finde sted efter den primære endepunktsanalyse.
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Fjernmetastaser og overlevelse
Tidsramme: Fra registrering til dødsdato eller sidste opfølgning. Analyse vil finde sted efter den primære endepunktsanalyse.
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Fra registrering til dødsdato eller sidste opfølgning. Analyse vil finde sted efter den primære endepunktsanalyse.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: James D. Cox, MD, M.D. Anderson 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
- Du KL, Bae K, Movsas B, Yan Y, Bryan C, Bruner DW. Impact of marital status and race on outcomes of patients enrolled in Radiation Therapy Oncology Group prostate cancer trials. Support Care Cancer. 2012 Jun;20(6):1317-25. doi: 10.1007/s00520-011-1219-4. Epub 2011 Jul 1.
- Roach M, Moughan J, Movsas B, et al.: Socio-demographic predictors of biochemical failure and survival among high risk patients treated on Radiation Therapy Oncology Group (RTOG) prostate cancer trials: a meta-analysis. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1127, S204, 2006.
- Michalski J, Winter K, Roach M, Markoe A, Sandler HM, Ryu J, Parliament M, Purdy JA, Valicenti RK, Cox JD. Clinical outcome of patients treated with 3D conformal radiation therapy (3D-CRT) for prostate cancer on RTOG 9406. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):e363-70. doi: 10.1016/j.ijrobp.2011.12.070.
- Tucker SL, Dong L, Michalski JM, Bosch WR, Winter K, Cox JD, Purdy JA, Mohan R. Do intermediate radiation doses contribute to late rectal toxicity? An analysis of data from radiation therapy oncology group protocol 94-06. Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):390-5. doi: 10.1016/j.ijrobp.2011.11.073. Epub 2012 Feb 17.
- Tucker SL, Michalski JM, Bosch WR, Mohan R, Dong L, Winter K, Purdy JA, Cox JD. Use of fractional dose-volume histograms to model risk of acute rectal toxicity among patients treated on RTOG 94-06. Radiother Oncol. 2012 Jul;104(1):109-13. doi: 10.1016/j.radonc.2012.04.023. Epub 2012 Jun 5.
- Tucker SL, Thames HD, Michalski JM, Bosch WR, Mohan R, Winter K, Cox JD, Purdy JA, Dong L. Estimation of alpha/beta for late rectal toxicity based on RTOG 94-06. Int J Radiat Oncol Biol Phys. 2011 Oct 1;81(2):600-5. doi: 10.1016/j.ijrobp.2010.11.080. Epub 2011 Mar 4.
- Valicenti RK, Bae K, Michalski J, Sandler H, Shipley W, Lin A, Cox J. Does hormone therapy reduce disease recurrence in prostate cancer patients receiving dose-escalated radiation therapy? An analysis of Radiation Therapy Oncology Group 94-06. Int J Radiat Oncol Biol Phys. 2011 Apr 1;79(5):1323-9. doi: 10.1016/j.ijrobp.2010.01.009.
- Michalski JM, Bae K, Roach M, Markoe AM, Sandler HM, Ryu J, Parliament MB, Straube W, Valicenti RK, Cox JD. Long-term toxicity following 3D conformal radiation therapy for prostate cancer from the RTOG 9406 phase I/II dose escalation study. Int J Radiat Oncol Biol Phys. 2010 Jan 1;76(1):14-22. doi: 10.1016/j.ijrobp.2009.01.062.
- Tucker SL, Dong L, Bosch WR, Michalski J, Winter K, Mohan R, Purdy JA, Kuban D, Lee AK, Cheung MR, Thames HD, Cox JD. Late rectal toxicity on RTOG 94-06: analysis using a mixture Lyman model. Int J Radiat Oncol Biol Phys. 2010 Nov 15;78(4):1253-60. doi: 10.1016/j.ijrobp.2010.01.069. Epub 2010 Jul 2.
- Cheung MR, Tucker SL, Dong L, et al.: Dose-volume analyses of grade ≥ 2 late rectal toxicity among patients treated on protocol RTOG 94-06. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-16, S9, 2007.
- Tucker SL, Dong L, Bosch WR, et al.: Fit of a generalized Lyman normal-tissue complication probability (NTCP) model to grade ≥ 2 late rectal toxicity data from patients treated on protocol RTOG 94-06. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-15, S8-9, 2007.
- Valicenti RK, Bae K, Michalski J, et al.: Does adjuvant hormonal therapy improve freedom from biochemical relapse in prostate cancer patients receiving dose- escalated radiation therapy? An analysis of RTOG 94-06. [Abstract] American Society of Clinical Oncology 2007 Prostate Cancer Symposium, 22-24 February 2007, Orlando, FL. A-297, 2007.
- Michalski JM, Winter K, Purdy JA, Parliament M, Wong H, Perez CA, Roach M, Bosch W, Cox JD. Toxicity after three-dimensional radiotherapy for prostate cancer on RTOG 9406 dose Level V. Int J Radiat Oncol Biol Phys. 2005 Jul 1;62(3):706-13. doi: 10.1016/j.ijrobp.2004.11.028.
- Michalski JM, Winter K, Purdy JA, Perez CA, Ryu JK, Parliament MB, Valicenti RK, Roach M 3rd, Sandler HM, Markoe AM, Cox JD. Toxicity after three-dimensional radiotherapy for prostate cancer with RTOG 9406 dose level IV. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):735-42. doi: 10.1016/S0360-3016(03)01578-5.
- Roach M, Winter K, Michalski JM, Cox JD, Purdy JA, Bosch W, Lin X, Shipley WS. Penile bulb dose and impotence after three-dimensional conformal radiotherapy for prostate cancer on RTOG 9406: findings from a prospective, multi-institutional, phase I/II dose-escalation study. Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1351-6. doi: 10.1016/j.ijrobp.2004.05.026.
- Michalski JM, Winter K, Purdy JA, Wilder RB, Perez CA, Roach M, Parliament MB, Pollack A, Markoe AM, Harms W, Sandler HM, Cox JD. Preliminary evaluation of low-grade toxicity with conformal radiation therapy for prostate cancer on RTOG 9406 dose levels I and II. Int J Radiat Oncol Biol Phys. 2003 May 1;56(1):192-8. doi: 10.1016/s0360-3016(03)00072-5.
- Michalski J, Winter K, Purdy JA, et al.: Toxicity following 3D radiation therapy for prostate cancer on RTOG 9406 dose level V. [Abstract] Int J Radiat Oncol Biol Phys 57 (2 Suppl): S151, 2003.
- Valicenti RK, Winter K, Cox JD, Sandler HM, Bosch W, Vijayakumar S, Michalski J, Purdy J. RTOG 94-06: is the addition of neoadjuvant hormonal therapy to dose-escalated 3D conformal radiation therapy for prostate cancer associated with treatment toxicity? Int J Radiat Oncol Biol Phys. 2003 Nov 1;57(3):614-20. doi: 10.1016/s0360-3016(03)00640-0.
- Michalski JM, Purdy JA, Winter K, Roach M 3rd, Vijayakumar S, Sandler HM, Markoe AM, Ritter MA, Russell KJ, Sailer S, Harms WB, Perez CA, Wilder RB, Hanks GE, Cox JD. Preliminary report of toxicity following 3D radiation therapy for prostate cancer on 3DOG/RTOG 9406. Int J Radiat Oncol Biol Phys. 2000 Jan 15;46(2):391-402. doi: 10.1016/s0360-3016(99)00443-5.
- Roach M, Winter K, Michalski J, et al.: Mean dose of radiation to the bulb of penis correlates with risk of impotence at 24 months: preliminary analysis of Radiation Therapy Oncology Group (RTOG) phase I/II dose escalation trial 94-06. Int J Radiat Oncol Biol Phys 48(3 suppl): A-2104, 316, 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. maj 1994
Primær færdiggørelse (Faktiske)
1. marts 2004
Studieafslutning (Faktiske)
1. november 2013
Datoer for studieregistrering
Først indsendt
1. november 1999
Først indsendt, der opfyldte QC-kriterier
25. maj 2004
Først opslået (Skøn)
26. maj 2004
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. januar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. januar 2020
Sidst verificeret
1. marts 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RTOG-9406
- CDR0000063854
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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