Pilocarpin til forebyggelse af slimhindebetændelse og mundtørhed hos patienter, der modtager strålebehandling for hoved- og nakkekræft
14. november 2015 opdateret af: Radiation Therapy Oncology Group
Et fase III-studie for at teste effektiviteten af den profylaktiske brug af oral pilocarpin til at reducere hyposalivation og slimhindebetændelse forbundet med helbredende strålebehandling hos patienter med hoved- og nakkekræft
RATIONALE: Strålebehandling bruger højenergi-røntgenstråler til at beskadige tumorceller. Lægemidler som pilocarpin kan beskytte normale celler mod bivirkninger af strålebehandling. Det vides endnu ikke, om pilocarpin kan være effektivt til at forebygge slimhindebetændelse og mundtørhed hos patienter, der får strålebehandling for hoved- og halskræft.
FORMÅL: Randomiseret, dobbeltblindet fase III-forsøg til undersøgelse af pilocarpins effektivitet til at forebygge slimhindebetændelse og mundtørhed hos patienter, der modtager strålebehandling for hoved- og halskræft.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
MÅL: I. Bestem, om profylaktisk brug af pilocarpin kan beskytte ustimuleret og stimuleret hele spytflow hos patienter med hoved- og halskræft. II. Bestem, om profylaktisk brug af pilocarpin kan moderere xerostomi hos disse patienter. III. Bestem, om profylaktisk brug af pilocarpin kan reducere graden og varigheden af strålingsinduceret mucositis hos disse patienter. IV. Evaluer livskvalitetsresultater mellem patienter, der får pilocarpin versus placebo. V. Evaluer virkningen af xerostomi på patienter, der modtager bestråling af hoved og nakke.
OVERSIGT: Dette er en randomiseret, dobbeltblind undersøgelse. Patienter modtager en central akse midtplansdosis af strålebehandling fem dage om ugen over 6 til 7 uger. Oral pilocarpin eller placebo indgives begyndende 3 dage før strålebehandling, en tablet fire gange dagligt i tre måneder. En tablet tages 45-60 minutter før strålebehandling. Efter tre måneder og efter en 3-4 dages hvileperiode får alle patienter ikke-blindet pilocarpin i en yderligere tre måneders periode. Patienterne følges i uge 4, 13 og 26 efter start af strålebehandling.
PROJEKTERET TILSLUTNING: I alt 244 patienter vil blive akkumuleret (122 pr. behandlingsarm).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
249
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Center - Calgary
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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British Columbia
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Victoria, British Columbia, Canada, V8R 1J8
- British Columbia Cancer Agency - Vancouver Island Cancer Centre
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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, 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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Montreal, Quebec, Canada, H2W-W1T8
- Centre Hospitalier de l'Université de Montréal
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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, 35233
- Veterans Affairs Medical Center - Birmingham
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Birmingham, Alabama, Forenede Stater, 35294
- University of Alabama Comprehensive Cancer Center
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Huntsville, Alabama, Forenede Stater, 35801
- Huntsville Hospital System
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Mobile, Alabama, Forenede Stater, 36688
- MBCCOP - University of South Alabama
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Mobile, Alabama, Forenede Stater, 36640
- Urology Associates - Mobile AL
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Montgomery, Alabama, Forenede Stater, 36106-2801
- Alabama Oncology, LLC
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Tuscallosa, Alabama, Forenede Stater, 35401
- Radiation Oncology Associates of West Alabama
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Alaska
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Anchorage, Alaska, Forenede Stater, 99508
- Providence Cancer Therapy Center
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Arizona
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Tucson, Arizona, Forenede Stater, 85724
- Arizona Cancer Center
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California
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Burbank, California, Forenede Stater, 91505
- Providence Saint Joseph Medical Center - Burbank
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Concord, California, Forenede Stater, 94524-4110
- Mount Diablo Medical Center
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Duarte, California, Forenede Stater, 91010
- 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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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, 90027
- Kaiser Permanente Medical Center - Los Angeles
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Martinez, California, Forenede Stater, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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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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Redding, California, Forenede Stater, 96099-6009
- Mercy Medical Center - Redding
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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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Santa Cruz, California, Forenede Stater, 95065
- Santa Cruz Radiation Oncology Medical Group, Inc.
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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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Travis Air Force Base, California, Forenede Stater, 94535
- David Grant Medical Center
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Walnut Creek, California, Forenede Stater, 94598
- Radiation Oncology Center - Walnut Creek
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80909
- Memorial Hospital Cancer Center
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Denver, Colorado, Forenede Stater, 80262
- University of Colorado Cancer Center
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Connecticut
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Bridgeport, Connecticut, Forenede Stater, 06610
- Bridgeport Hospital
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Norwalk, Connecticut, Forenede Stater, 06856
- Whittingham Cancer Center
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Delaware
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Wilmington, Delaware, Forenede Stater, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20307-5000
- Walter Reed Army Medical Center
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Florida
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Clearwater, Florida, Forenede Stater, 33757-0210
- Lykes Center for Radiation Therapy
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Daytona Beach, Florida, Forenede Stater, 32114
- Halifax Medical Center
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Fort Myers, Florida, Forenede Stater, 33901
- Radiation Therapy Associates - Fort Myers
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Gainesville, Florida, Forenede Stater, 32610-0296
- University of Florida Health Science Center
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Melbourne, Florida, Forenede Stater, 32901
- Health First Holmes Regional Medical Center
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Miami, Florida, Forenede Stater, 33136
- Sylvester Cancer Center, University of Miami
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Miami, Florida, Forenede Stater, 33176-2197
- Baptist Hospital of Miami
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Miami 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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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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Rome, Georgia, Forenede Stater, 30161
- InterCommunity Cancer Center at Rome
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Valdosta, Georgia, Forenede Stater, 31603
- South Georgia Medical Center
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Illinois
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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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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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Springfield, Illinois, Forenede Stater, 62526
- CCOP - Central Illinois
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Urbana, Illinois, Forenede Stater, 61801
- CCOP - Carle Cancer Center
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Indiana
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Anderson, Indiana, Forenede Stater, 46016
- 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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Bowling Green, Kentucky, Forenede Stater, 42102
- Medical Center at Bowling Green
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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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Metairie, Louisiana, Forenede Stater, 70011
- East Jefferson General Hospital
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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, 21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
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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, 21287
- Johns Hopkins Oncology Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital Cancer Center
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Boston, Massachusetts, Forenede Stater, 02215
- Joint Center for Radiation Therapy
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Hyannis, Massachusetts, Forenede Stater, 02601
- Cape Cod Hospital
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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, 48105
- Veterans Affairs Medical Center - Ann Arbor
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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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Kalamazoo, Michigan, Forenede Stater, 49007-3731
- CCOP - Kalamazoo
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Marquette, Michigan, Forenede Stater, 49855
- Marquette General Hospital
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Saginaw, Michigan, Forenede Stater, 48601
- St. Mary's Medical Center
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- CCOP - Metro-Minnesota
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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, 63106
- Veterans Affairs Medical Center - Saint Louis
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Saint Louis, Missouri, Forenede Stater, 63110
- Mallinckrodt Institute of Radiology
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Springfield, Missouri, Forenede Stater, 65807
- Cancer Research for the Ozarks
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Springfield, Missouri, Forenede Stater, 65807
- CCOP - Ozarks Regional
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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, 68131
- CCOP - Missouri Valley Cancer Consortium
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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
- Elizabeth General Medical Center - West
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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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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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Albany, New York, Forenede Stater, 12208
- Veterans Affairs Medical Center - Albany
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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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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, 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, 14607
- Genesee Hospital - Rochester
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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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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 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
- UNI-MED Medical Center
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Ohio
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Akron, Ohio, Forenede Stater, 44302
- Akron General Medical Center
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Akron, Ohio, Forenede Stater, 44309
- Akron City Hospital
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Cincinnati, Ohio, Forenede Stater, 45219
- Christ Hospital
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Cleveland, Ohio, Forenede Stater, 44106-5065
- Ireland Cancer Center
-
Columbus, Ohio, Forenede Stater, 43206
- CCOP - Columbus
-
Columbus, Ohio, Forenede Stater, 43210
- Arthur G. James Cancer Hospital - Ohio State University
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Dayton, Ohio, Forenede Stater, 45428
- Veterans Affairs Medical Center - Dayton
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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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Corvallis, Oregon, Forenede Stater, 97339
- Samaritan Regional Cancer Center
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Portland, Oregon, Forenede Stater, 97213
- CCOP - Columbia River Program
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Pennsylvania
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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
-
Philadelphia, Pennsylvania, Forenede Stater, 19102-1192
- Allegheny University Hospitals- Hahnemann
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania Cancer Center
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- Veterans Affairs Medical Center - Philadelphia
-
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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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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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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Sellersville, Pennsylvania, Forenede Stater, 18960
- Grand View Hospital
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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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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
-
Knoxville, Tennessee, Forenede Stater, 37901
- Baptist Regional Cancer Center - Knoxville
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Memphis, Tennessee, Forenede Stater, 38117
- CCOP - Baptist Cancer Institute
-
Memphis, Tennessee, Forenede Stater, 38163
- University of Tennessee, Memphis Cancer Center
-
Nashville, Tennessee, Forenede Stater, 37232-6838
- Vanderbilt Cancer Center
-
-
Texas
-
Beaumont, Texas, Forenede Stater, 77701
- Julie and Ben Rogers Cancer Institute
-
Galveston, Texas, Forenede Stater, 77555-1329
- University of Texas Medical Branch
-
Houston, Texas, Forenede Stater, 77030
- University of Texas - MD Anderson Cancer Center
-
Lackland Air Force Base, Texas, Forenede Stater, 78236-5300
- Wilford Hall - 59th Medical Wing
-
Pasadena, Texas, Forenede Stater, 77504
- Bayshore Medical Center
-
-
Utah
-
Saint George, Utah, Forenede Stater, 84770
- Dixie Regional Medical Center
-
Salt Lake City, Utah, Forenede Stater, 84143
- LDS Hospital
-
-
Vermont
-
Bennington, Vermont, Forenede Stater, 05201
- CCOP - Southwestern Vermont Regional Cancer Center
-
Rutland, Vermont, Forenede Stater, 05701
- Green Mountain Oncology Group
-
White River Junction, Vermont, Forenede Stater, 05009
- Veterans Affairs Medical Center - White River Junction
-
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22901
- Martha Jefferson Hospital
-
Charlottesville, Virginia, Forenede Stater, 22908
- Cancer Center, University of Virginia HSC
-
Lynchburg, Virginia, Forenede Stater, 24503
- Virginia Baptist Hospital
-
Portsmouth, Virginia, Forenede Stater, 23708-2197
- Naval Medical Center, Portsmouth
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Richmond, Virginia, Forenede Stater, 23298-0037
- Massey Cancer Center
-
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Washington
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Seattle, Washington, Forenede Stater, 98104
- Swedish Hospital Tumor Institute
-
Seattle, Washington, Forenede Stater, 98111
- Virginia Mason Medical Center
-
Spokane, Washington, Forenede Stater, 99210-0248
- Deaconess Medical Center
-
Yakima, Washington, Forenede Stater, 98902
- Yakima Valley Memorial Hospital
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West Virginia
-
Wheeling, West Virginia, Forenede Stater, 26003
- Schiffler Oncology Center
-
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Wisconsin
-
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, 53705
- Veterans Affairs Medical Center - Madison
-
Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin Comprehensive Cancer Center
-
Madison, Wisconsin, Forenede Stater, 53713
- Southern Wisconsin Radiotherapy Center
-
Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Clinic
-
Menomonee Falls, Wisconsin, Forenede Stater, 53051
- Community Memorial Hospital
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin
-
Milwaukee, Wisconsin, Forenede Stater, 53210
- St. Joseph's Hospital
-
Milwaukee, Wisconsin, Forenede Stater, 53211
- Columbia Hospital
-
Milwaukee, Wisconsin, Forenede Stater, 53215
- St. Luke's Medical Center
-
Milwaukee, Wisconsin, Forenede Stater, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
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Racine, Wisconsin, Forenede Stater, 53405
- Southeastern Wisconsin Regional Cancer Center
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SYGDOMSKARAKTERISTIKA: Histologisk dokumenteret mundhule og/eller orofaryngealt planocellulært karcinom. Strålingsvolumen omfatter mindst 50 % af ørespytkirtlerne og har mindst 50 Gy leveret til dette volumen via ekstern stråle. Ingen spytkirtel maligniteter eller sygdomme
PATIENT KARAKTERISTIKA: Alder: 18 og derover Ydeevne Status: Karnofsky 60-100% Forventet levetid: Ikke specificeret Hæmatopoietisk: Ikke specificeret Lever: Ikke specificeret Nyre: Ikke specificeret Andet: Ikke gravid eller ammende Effektiv præventionsmetode skal bruges under undersøgelsen Ingen pilocarpinallergi
FORUDSÆTNING SAMTYDLIG BEHANDLING: Biologisk terapi: Ikke specificeret Kemoterapi: Ikke specificeret Endokrin terapi: Ikke specificeret Strålebehandling: Ingen forudgående strålebehandling til hoved eller hals Kirurgi: Ikke specificeret Andet: Ingen samtidige adrenerge antagonister, kolinerge lægemidler, anti-cholinergika eller tricykliske midler
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Pilocarpin hydroclorid
5 mg pilocarpin hydrochlorid tabletter, der påbegyndes 3 dage før bestråling
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5 mg pilocarpin hydrochlorid tabletter
|
|
Placebo komparator: Placebo
Placebotabletter, der påbegyndes 3 dage før bestråling
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Akut spytkirteltoksicitet
Tidsramme: Fra behandlingsstart til 13 uger
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Fra behandlingsstart til 13 uger
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Akut mucositis i svælget, ganen, tungen eller mundhulen
Tidsramme: Fra behandlingsstart til 13 uger
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Fra behandlingsstart til 13 uger
|
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Livskvalitet målt ved University of Washington Head and Neck Symptom spørgeskema
Tidsramme: Forbehandling til 26 uger fra behandlingsstart
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Forbehandling til 26 uger fra behandlingsstart
|
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Virkninger af at fortsætte pilocarpin ud til 6 måneder fra behandlingsstart
Tidsramme: Fra behandlingsstart til 26 uger
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Fra behandlingsstart til 26 uger
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Francis G. LeVeque, DDS, Barbara Ann Karmanos Cancer Institute
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
- Scarantino C, LeVeque F, Swann RS, White R, Schulsinger A, Hodson DI, Meredith R, Foote R, Brachman D, Lee N. Effect of pilocarpine during radiation therapy: results of RTOG 97-09, a phase III randomized study in head and neck cancer patients. J Support Oncol. 2006 May;4(5):252-8.
- Fisher J, Scott C, Scarantino CW, Leveque FG, White RL, Rotman M, Hodson DI, Meredith RF, Foote R, Bachman DG, Lee N. Phase III quality-of-life study results: impact on patients' quality of life to reducing xerostomia after radiotherapy for head-and-neck cancer--RTOG 97-09. Int J Radiat Oncol Biol Phys. 2003 Jul 1;56(3):832-6. doi: 10.1016/s0360-3016(03)00121-4.
- Fisher JJ, Scott CB, Scarantino CW, et al.: Phase III quality of life (Qol) study: reduction in hyposalivation does not improve Qol for head and neck (H&N) cancer patients post radiation therapy (P-RT). RTOG 9709. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1423, 2002.
- Scarantino CW, Leveque FG, Scott CB, et al.: A phase III study of concomitant oral pilocarpine to reduce hypo-salivation and mucositis associated with curative radiation therapy (RT) in the head and neck (H&N) cancer patients. RTOG 9709. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-897, 225a, 2001.
- Scarantino CW, Leveque F, Scott C, et al.: A phase III study on the concurrent use of oral pilocarpine to reduce hyposalivation and mucositis associated with radiation therapy in head and neck cancer patients: final results of RTOG 97-09. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-157, 85-86, 2001.
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. marts 1998
Primær færdiggørelse (Faktiske)
1. januar 2001
Studieafslutning (Faktiske)
1. oktober 2002
Datoer for studieregistrering
Først indsendt
1. november 1999
Først indsendt, der opfyldte QC-kriterier
3. september 2004
Først opslået (Skøn)
6. september 2004
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. november 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. november 2015
Sidst verificeret
1. november 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale sygdomme
- Gastroenteritis
- Stomatognatiske sygdomme
- Mundsygdomme
- Neoplasmer i hoved og hals
- Mucositis
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystem
- Kolinerge midler
- Kolinerge agonister
- Miotics
- Muskarine agonister
- Pilocarpin
Andre undersøgelses-id-numre
- RTOG-9709
- CDR0000065912
- NCI-P97-0121
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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 .