Stråleterapi og kombinationskemoterapi til behandling af patienter med stadium II eller stadium III blærekræft
19. oktober 2020 opdateret af: Radiation Therapy Oncology Group
Et fase I/II-forsøg i patienter med muskelinvaderende blærekræft af transurethral kirurgi plus taxol, cisplatin og budbestråling efterfulgt af enten selektiv blærekonservering eller radikal cystektomi og adjuverende kemoterapi
RATIONALE: Strålebehandling bruger røntgenstråler til at beskadige tumorceller. Lægemidler, der bruges i kemoterapi, bruger forskellige måder til at stoppe tumorceller i at dele sig, så de holder op med at vokse eller dør. Kombination af strålebehandling med kemoterapi og kirurgi kan dræbe flere tumorceller.
FORMÅL: Fase I/II-forsøg til undersøgelse af effektiviteten af strålebehandling plus kombinationskemoterapi til behandling af patienter, der har stadium II eller stadium III blærekræft, som kan fjernes ved kirurgi.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
MÅL:
- Evaluer sikkerheden og tolerabiliteten af induktionskemoradioterapi med paclitaxel og cisplatin efterfulgt af selektiv blærekonservering eller radikal cystektomi og adjuverende kemoterapi hos patienter med stadium II eller III muskelinvasivt blærekarcinom, som tidligere er behandlet med transurethral tumorresektion.
- Evaluer effektiviteten af transurethral tumorresektion og induktionskemoradioterapi til at opnå et fuldstændigt respons i denne patientpopulation.
- Vurder værdien af tumorparametre som prognostiske faktorer for initial tumorrespons og recidivfri overlevelse i denne patientpopulation.
OVERSIGT: Fire til seks uger efter forudgående transurethral resektion modtager patienter induktionsterapi omfattende paclitaxel IV over 1 time på dag 1, 8 og 15, cisplatin IV over 1 time på dag 1, 2, 8, 9, 15 og 16, og strålebehandling to gange dagligt på dag 1-5, 8-12 og 17.
Fire uger efter induktionsterapi gennemgår patienterne urologisk evaluering. 1-2 uger efter evaluering modtager patienter med komplet respons konsolideringsterapi omfattende paclitaxel IV over 1 time på dag 1 og 8, cisplatin IV over 1 time på dag 1, 2, 8 og 9 og strålebehandling to gange dagligt på dag 1 -5 og 8-10. Patienter med dårlig tumorrespons gennemgår en cystektomi.
12 uger efter konsolideringsbehandling eller 8 uger efter radikal cystektomi får patienterne adjuverende kemoterapi omfattende gemcitabin IV over 30-60 minutter efterfulgt af cisplatin IV over 1 time hver 3. uge. Behandlingen gentages hver 4. uge i 4 forløb i fravær af sygdomsprogression eller uacceptabel toksicitet.
Patienterne følges hver 4. måned i 1 år, hver 6. måned i 3 år og derefter årligt.
PROJEKTERET TILSLUTNING: I alt 84 patienter vil blive akkumuleret til denne undersøgelse inden for 3 år.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
84
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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Saint John, New Brunswick, Canada, E2L 4L2
- Saint John Regional Hospital
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Newfoundland and Labrador
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St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
- Newfoundland Cancer Treatment and Research Foundation
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Cancer Centre
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Cancer Care Ontario-Hamilton Regional Cancer Centre
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Kingston, Ontario, Canada, K7L 5P9
- Kingston Regional Cancer Centre
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London, Ontario, Canada, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Ottawa, Ontario, Canada, K1H 1C4
- Ottawa Regional Cancer Centre
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Sudbury, Ontario, Canada, P3E 5J1
- Northeastern Ontario Regional Cancer Centre, Sudbury
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Thunder Bay, Ontario, Canada, P7A 7T1
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
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Toronto, Ontario, Canada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Fleurimont, Quebec, Canada, J1H 5N4
- CHUS-Hopital Fleurimont
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Montreal, Quebec, Canada, H2W 1S6
- McGill University
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Montreal, Quebec, Canada, H2L-4M1
- Centre Hospitalier de l'Université de Montréal
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Quebec City, Quebec, Canada, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
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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, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Huntsville, Alabama, Forenede Stater, 35801
- Comprehensive Cancer Institute of Huntsville
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Huntsville, Alabama, Forenede Stater, 35801-4470
- Huntsville Hospital System
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Mobile, Alabama, Forenede Stater, 36688
- MBCCOP - Gulf Coast
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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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Arizona
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Phoenix, Arizona, Forenede Stater, 85013
- Foundation for Cancer Research and Education
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California
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Concord, California, Forenede Stater, 94524-4110
- Mount Diablo Medical Center
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Duarte, California, Forenede Stater, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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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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Greenbrae, California, Forenede Stater, 94904
- Sutter Health West 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, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Forenede Stater, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Oakland, California, Forenede Stater, 94609-3305
- CCOP - Bay Area Tumor Institute
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Pasadena, California, Forenede Stater, 91105
- Huntington Cancer Center
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Pomona, California, Forenede Stater, 91767
- Cancer Care Center
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Sacramento, California, Forenede Stater, 95816
- Radiation Oncology Center - Sacramento
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San Diego, California, Forenede Stater, 92101-1492
- Radiation Medical Group, Inc.
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San Francisco, California, Forenede Stater, 94143-0128
- 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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Travis Air Force Base, California, Forenede Stater, 94535
- David Grant Medical Center
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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, 80010
- University of Colorado Cancer Center
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Grand Junction, Colorado, Forenede Stater, 81502
- Saint Mary's Hospital and Medical Center
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Delaware
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Wilmington, Delaware, Forenede Stater, 19899
- CCOP - Christiana Care Health Services
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Florida
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Gainesville, Florida, Forenede Stater, 32610-0296
- University of Florida Health Science Center
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Melbourne, Florida, Forenede Stater, 32901
- Health First Holmes Regional Medical Center
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Miami, Florida, Forenede Stater, 33136
- Sylvester Cancer Center, University of Miami
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Miami, Florida, Forenede Stater, 33176-2197
- Baptist Hospital of Miami
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Miami, Florida, Forenede Stater, 33125
- Veterans Affairs Medical Center - Miami
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Miami Beach, Florida, Forenede Stater, 33140
- CCOP - Mount Sinai Medical Center
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Orange Park, Florida, Forenede Stater, 32073
- Florida Radiation Oncology Group
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Orlando, Florida, Forenede Stater, 32806
- MD Anderson Cancer Center Orlando
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Panama City, Florida, Forenede Stater, 32405-4587
- Gulf Coast Cancer Treatment Center
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Panama City, Florida, Forenede Stater, 32401
- Bay Medical Center
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Sarasota, Florida, Forenede Stater, 34233
- Sarasota Radiation and Medical Oncology Center
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Tallahassee, Florida, Forenede Stater, 32308
- Tallahassee Memorial HealthCare
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Tampa, Florida, Forenede Stater, 33612-9497
- 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, 30165
- Regional Radiation Oncology Center at Rome
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- MBCCOP - Hawaii
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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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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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Bloomington, Indiana, Forenede Stater, 47402
- Bloomington Hospital
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Indianapolis, Indiana, Forenede Stater, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
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Indianapolis, Indiana, Forenede Stater, 46219
- Community Hospitals of Indianapolis - Regional Cancer Center
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Indianapolis, Indiana, Forenede Stater, 46206-1367
- Clarian Health Partners Inc.
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Muncie, Indiana, Forenede Stater, 47303-3499
- Ball Memorial Hospital
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South Bend, Indiana, Forenede Stater, 46601
- CCOP - Northern Indiana CR Consortium
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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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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington, Kentucky, Forenede Stater, 40503
- Central Baptist Hospital
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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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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809
- Mary Bird Perkins Cancer 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, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, Forenede Stater, 70112
- MBCCOP - LSU Health Sciences Center
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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, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Forenede Stater, 21225
- Sinai Hospital of Baltimore
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Baltimore, Maryland, Forenede Stater, 21204
- Greater Baltimore Medical Center and Cancer Center
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Baltimore, Maryland, Forenede Stater, 21225
- Harbor Hospital Center
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Salisbury, Maryland, Forenede Stater, 21801
- Peninsula Regional Medical Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital Cancer Center
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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, 48202
- Henry Ford Hospital
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Detroit, Michigan, Forenede Stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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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 Medical Center - Midland
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Royal Oak, Michigan, Forenede Stater, 48073
- William Beaumont Hospital
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Troy, Michigan, Forenede Stater, 48098
- William Beaumont Hospital - Troy
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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, 63108
- Mallinckrodt Institute of Radiology
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Springfield, Missouri, Forenede Stater, 65807
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Forenede Stater, 65807
- Cancer Research for the Ozarks
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Montana
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Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68114
- Methodist Cancer Center - Omaha
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Omaha, Nebraska, Forenede Stater, 68198-7460
- Nebraska Health System
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756-0002
- Norris Cotton Cancer Center
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Manchester, New Hampshire, Forenede Stater, 03103
- Elliot Regional Cancer Center
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New Jersey
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Camden, New Jersey, Forenede Stater, 08103
- Cooper Cancer Institute
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East Orange, New Jersey, Forenede Stater, 07018-1095
- Veterans Affairs Medical Center - East Orange
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Edison, New Jersey, Forenede Stater, 08818
- John F. Kennedy Medical Center
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Elizabeth, New Jersey, Forenede Stater, 07201
- Trinitas Hospital - Jersey Street Campus
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Long Branch, New Jersey, Forenede Stater, 07740-6395
- Monmouth Medical Center
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Millville, New Jersey, Forenede Stater, 08332
- South Jersey Regional Cancer Center
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Mount Holly, New Jersey, Forenede Stater, 08060
- Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
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New Brunswick, New Jersey, Forenede Stater, 08903
- Cancer Institute Of New Jersey
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Newark, New Jersey, Forenede Stater, 07112
- Newark Beth Israel Medical Center
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Pomona, New Jersey, Forenede Stater, 08240
- Atlantic City Medical Center
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Ridgewood, New Jersey, Forenede Stater, 07450
- Valley Hospital
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Toms River, New Jersey, Forenede Stater, 08755
- Community Medical Center
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Trenton, New Jersey, Forenede Stater, 08629
- St. Francis Medical Center
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Warren, New Jersey, Forenede Stater, 07059
- Associated Radiologists, P.A.
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87109
- Radiation Oncology Associates of Albuquerque
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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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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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Clifton Springs, New York, Forenede Stater, 14432
- Finger Lakes Radiation Oncology Center
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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, 10032
- Herbert Irving Comprehensive Cancer Center
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Plattsburgh, New York, Forenede Stater, 12901
- Champlain Valley Physicians Hospital Medical Center
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Poughkeepsie, New York, Forenede Stater, 12601
- Vassar Brothers Hospital
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Rochester, New York, Forenede Stater, 14642
- University of Rochester Cancer Center
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Syracuse, New York, Forenede Stater, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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Yonkers, New York, Forenede Stater, 10701
- Riverhill Radiation Oncology
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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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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 at Wake Forest University
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North Dakota
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Minot, North Dakota, Forenede Stater, 58701
- Trinity Cancer Care 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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Cincinnati, Ohio, Forenede Stater, 45267-0502
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Taussig 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, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Columbus, Ohio, Forenede Stater, 43206
- CCOP - Columbus
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Kettering, Ohio, Forenede Stater, 45429
- CCOP - Dayton
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Toledo, Ohio, Forenede Stater, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73190
- University of Oklahoma Health Sciences Center
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Oklahoma City, Oklahoma, Forenede Stater, 73101
- St. Anthony Hospital
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Tulsa, Oklahoma, Forenede Stater, 74104
- St. John Health System
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Oregon
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Portland, Oregon, Forenede Stater, 97213
- CCOP - Columbia River Program
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater, 18103
- LeHigh Valley Hospital
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Bethlehem, Pennsylvania, Forenede Stater, 18015
- St. Luke's Hospital Regional Cancer Center
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Danville, Pennsylvania, Forenede Stater, 17822-2001
- Geisinger Medical Center
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Darby, Pennsylvania, Forenede Stater, 19023
- Fitzgerald Mercy Hospital
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Drexel Hill, Pennsylvania, Forenede Stater, 19026
- Delaware County Memorial Hospital
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East Stroudsburg, Pennsylvania, Forenede Stater, 18301
- Pocono Cancer Center
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Hershey, Pennsylvania, Forenede Stater, 17033-0850
- Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Forenede Stater, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Veterans Affairs Medical Center - Philadelphia
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Philadelphia, Pennsylvania, Forenede Stater, 19141
- Albert Einstein Cancer Center
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Philadelphia, Pennsylvania, Forenede Stater, 19104-4283
- University of Pennsylvania Cancer Center
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Philadelphia, Pennsylvania, Forenede Stater, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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Pittsburgh, Pennsylvania, Forenede Stater, 15224
- Western Pennsylvania Hospital
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Pittsburgh, Pennsylvania, Forenede Stater, 15213-3489
- 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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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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Greenville, South Carolina, Forenede Stater, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Forenede Stater, 29303
- CCOP - Upstate Carolina
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South Dakota
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Rapid City, South Dakota, Forenede Stater, 57709
- Rapid City Regional Hospital
-
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Tennessee
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Jackson, Tennessee, Forenede Stater, 38301
- Jackson-Madison County General Hospital
-
Memphis, Tennessee, Forenede Stater, 38103
- University of Tennessee, Memphis Cancer Center
-
Nashville, Tennessee, Forenede Stater, 37232-6838
- Vanderbilt-Ingram Cancer Center
-
-
Texas
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Amarillo, Texas, Forenede Stater, 79106
- Harrington Cancer Center
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Galveston, Texas, Forenede Stater, 77555-0209
- University of Texas Medical Branch
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Houston, Texas, Forenede Stater, 77030-4009
- University of Texas - MD Anderson Cancer Center
-
Lackland Air Force Base, Texas, Forenede Stater, 78236-5300
- Wilford Hall - 59th Medical Wing
-
Lubbock, Texas, Forenede Stater, 79410-1894
- Joe Arrington Cancer Research and Treatment Center
-
Pasadena, Texas, Forenede Stater, 77504
- Bayshore Medical Center
-
-
Utah
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Saint George, Utah, Forenede Stater, 84770
- Dixie Regional Medical Center
-
Salt Lake City, Utah, Forenede Stater, 84132
- University of Utah Health Sciences Center
-
Salt Lake City, Utah, Forenede Stater, 84143
- Latter Day Saints Hospital
-
-
Vermont
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Bennington, Vermont, Forenede Stater, 05201
- Green Mountain Oncology Group
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Burlington, Vermont, Forenede Stater, 05401-3498
- Vermont Cancer Center
-
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- Cancer Center at the University of Virginia
-
Harrisonburg, Virginia, Forenede Stater, 22801
- RMH Regional Cancer Center
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Portsmouth, Virginia, Forenede Stater, 23708-2197
- Naval Medical Center, Portsmouth
-
Richmond, Virginia, Forenede Stater, 23298-0037
- Massey Cancer Center
-
Richmond, Virginia, Forenede Stater, 23226
- Bon-Secours - St. Mary's Hospital
-
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Washington
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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
-
-
West Virginia
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Wheeling, West Virginia, Forenede Stater, 26003
- Schiffler Cancer Center
-
-
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, 53792-6164
- 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, 53211
- Columbia Hospital
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Milwaukee, Wisconsin, Forenede Stater, 53215
- St. Luke's Medical Center
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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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Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
SYGDOMS KARAKTERISTIKA:
Histologisk bekræftet stadium II eller III (T2-4a, Nx eller N0, M0) primært blærekarcinom med muskelinvasion
- Resektabel sygdom
- Prostatisk urethral involvering med overgangscellekarcinom tilladt, hvis fuldstændigt reseceret og ingen tegn på stromal invasion
- Ingen tumorrelateret hydronefrose
Positiv lymfeknude skal evalueres ved lymfadenektomi eller perkutan nålebiopsi
- Ingen nodale metastaser
- Ingen fjernmetastaser
Ikke mere end 6 uger siden forudgående transurethral resektion af blæretumoren
- Fungerende blære
PATIENT KARAKTERISTIKA:
Alder:
- Voksen
Ydeevnestatus:
- Zubrod 0-1
Forventede levealder:
- Ikke specificeret
Hæmatopoietisk:
- Hæmoglobin mindst 10 g/dL
- Antal hvide blodlegemer (WBC) på mindst 4.000/mm^3
- Absolut neutrofiltal mindst 1.800/mm^3
- Blodpladetal mindst 100.000/mm^3
Hepatisk:
- Bilirubin ikke større end 2,0 mg/dL
Nyre:
- Kreatinin ikke større end 1,5 mg/dL
- Kreatininclearance mindst 60 ml/min
Andet:
- Ingen anden tidligere eller samtidig malignitet inden for de sidste 5 år undtagen kurativt behandlet non-melanom hudkræft, stadium I prostatacancer eller carcinom in situ i livmoderhalsen
- Ikke gravid
- Negativ graviditetstest
- Fertile patienter skal bruge effektiv prævention
- Medicinsk operativ
FORUDSÆTNING SAMTYDLIG TERAPI:
Biologisk terapi:
- Ikke specificeret
Kemoterapi:
- Ingen forudgående systemisk kemoterapi
Endokrin terapi:
- Ikke specificeret
Strålebehandling:
- Ingen forudgående strålebehandling af bækkenet
Kirurgi:
- Se Sygdomskarakteristika
Andet:
- Ingen samtidige potentielle nefrotoksiske eller ototoksiske lægemidler (f.eks. aminoglykosider)
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm 1
Transurethral kirurgi med kemoterapi og strålebehandling efterfulgt af enten selektiv blærekonservering eller radikal cystektomi efterfulgt af adjuverende kemoterapi.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Afslutning og sikkerhed af induktionskemo-strålebehandling efterfulgt af definitiv lokal terapi af enten radikal cystektomi eller konsolidering af TCI, efterfulgt af fire cyklusser med ambulant adjuverende gemcitabin-cisplatin-kemoterapi.
Tidsramme: Fra start til slut af al protokolterapi
|
Afslutning og sikkerhed af induktionskemo-strålebehandling (cisplatin, paclitaxel og bestråling [TCI]) efterfulgt af definitiv lokal terapi af enten radikal cystektomi (for patienter, for hvem den initiale tumor ikke er et fuldstændigt respons) eller konsoliderings-TCI (for patienter, for hvem initial tumor er ryddet), efterfulgt af fire cyklusser med ambulant adjuverende gemcitabin-cisplatin kemoterapi.
|
Fra start til slut af al protokolterapi
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Komplet respons efter TCI-induktion
Tidsramme: Fra start til slut af al protokolterapi
|
Fra start til slut af al protokolterapi
|
|
Afslutning og sikkerhed af de fire cyklusser af gemcitabin-cisplatin kemoterapi
Tidsramme: Fra start til slut af al protokolterapi
|
Fra start til slut af al protokolterapi
|
|
Invasiv lokal behandlingssvigt
Tidsramme: Fra start af protokolbehandling til dato for lokal svigt. Analyse sker, efter at alle patienter har afsluttet behandlingen.
|
Fra start af protokolbehandling til dato for lokal svigt. Analyse sker, efter at alle patienter har afsluttet behandlingen.
|
|
Fjernmetastaser
Tidsramme: Fra start af protokolbehandling til dato for fjernmetastasering
|
Fra start af protokolbehandling til dato for fjernmetastasering
|
|
At undersøge værdien af tumorhistopatologi, molekylær genetik og DNA flowcytometriske parametre som mulige signifikante prognostiske faktorer for initial tumorrespons og gentagelsesfri overlevelse.
Tidsramme: Fra start af protokolbehandling til den dato, hvor sidste patient har afsluttet behandlingen. Analyse sker, efter at alle patienter har afsluttet behandlingen.
|
Fra start af protokolbehandling til den dato, hvor sidste patient har afsluttet behandlingen. Analyse sker, efter at alle patienter har afsluttet behandlingen.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Donald S. Kaufman, MD, Massachusetts General Hospital
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
- Efstathiou JA, Bae K, Shipley WU, Kaufman DS, Hagan MP, Heney NM, Sandler HM. Late pelvic toxicity after bladder-sparing therapy in patients with invasive bladder cancer: RTOG 89-03, 95-06, 97-06, 99-06. J Clin Oncol. 2009 Sep 1;27(25):4055-61. doi: 10.1200/JCO.2008.19.5776. Epub 2009 Jul 27.
- Shipley WU, Bae K, Efstathiou JA, et al.: Late pelvic toxicity following bladder-sparing therapy in patients with invasive bladder cancer: analysis of RTOG 89-03, 95-06, 97-06, 99-06. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-14, S8, 2007.
- Kaufman DS, Winter KA, Shipley WU, Heney NM, Wallace HJ 3rd, Toonkel LM, Zietman AL, Tanguay S, Sandler HM. Phase I-II RTOG study (99-06) of patients with muscle-invasive bladder cancer undergoing transurethral surgery, paclitaxel, cisplatin, and twice-daily radiotherapy followed by selective bladder preservation or radical cystectomy and adjuvant chemotherapy. Urology. 2009 Apr;73(4):833-7. doi: 10.1016/j.urology.2008.09.036. Epub 2008 Dec 18.
- Kaufman DS, Winter KA, Shipley WU, et al.: Muscle-invading bladder cancer, RTOG Protocol 99-06: initial report of a phase I/II trial of selective bladder-conservation employing TURBT, accelerated irradiation sensitized with cisplatin and paclitaxel followed by adjuvant cisplatin and gemcitabine chemotherapy. [Abstract] J Clin Oncol 23 (Suppl 16): A-4506, 379s, 2005.
- Mak RH, Hunt D, Shipley WU, Efstathiou JA, Tester WJ, Hagan MP, Kaufman DS, Heney NM, Zietman AL. Long-term outcomes in patients with muscle-invasive bladder cancer after selective bladder-preserving combined-modality therapy: a pooled analysis of Radiation Therapy Oncology Group protocols 8802, 8903, 9506, 9706, 9906, and 0233. J Clin Oncol. 2014 Dec 1;32(34):3801-9. doi: 10.1200/JCO.2014.57.5548. Epub 2014 Nov 3. Erratum In: J Clin Oncol. 2015 Mar 1;33(7):814.
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. september 1999
Primær færdiggørelse (Faktiske)
1. juli 2003
Studieafslutning (Faktiske)
1. november 2013
Datoer for studieregistrering
Først indsendt
1. november 1999
Først indsendt, der opfyldte QC-kriterier
29. september 2003
Først opslået (Skøn)
30. september 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. oktober 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. oktober 2020
Sidst verificeret
1. oktober 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Urologiske sygdomme
- Urinblæresygdomme
- Urinblære neoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Gemcitabin
- Paclitaxel
- Cisplatin
Andre undersøgelses-id-numre
- RTOG-9906
- CDR0000067122
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 .