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Sargramostim til at reducere slimhindebetændelse hos patienter, der modtager strålebehandling for hoved- og nakkekræft

18. november 2013 opdateret af: Radiation Therapy Oncology Group

Et fase III-studie for at teste effektiviteten og sikkerheden af GM-CSF for at reducere sværhedsgraden og varigheden af slimhindeskader og smerter (slimhindebetændelse) forbundet med helbredende strålebehandling hos patienter med hoved- og nakkekræft

RATIONALE: Sargramostim kan mindske symptomer på slimhindebetændelse hos patienter, der får strålebehandling for hoved- og halskræft. Det vides endnu ikke, om sargramostim er mere effektivt end ingen behandling til at reducere mucositis forårsaget af strålebehandling.

FORMÅL: Randomiseret fase III-forsøg til at bestemme effektiviteten af sargramostim til at mindske slimhindebetændelse hos patienter, der modtager strålebehandling for hoved- og halskræft.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

MÅL:

Bestem effektiviteten af sargramostim (GM-CSF) med hensyn til at reducere sværhedsgraden og den forventede varighed af stråleterapi-induceret oral mucositis hos patienter med hoved- og halscancer, der får strålebehandling.
Bestem sammenhængen mellem reduceret slimhindeskade og forbedring af livskvaliteten hos patienter behandlet med dette lægemiddel.

OVERSIGT: Dette er en randomiseret, dobbeltblind, placebokontrolleret undersøgelse. Patienterne stratificeres efter samtidig cisplatin-kemoterapi (ja vs nej). Patienterne randomiseres til 1 ud af 2 behandlingsarme.

Arm I: Patienter modtager strålebehandling én gang dagligt fem dage om ugen i 6-7 uger. Patienter får også sargramostim (GM-CSF) subkutant (SC) tre gange om ugen (undtagen på dage, hvor de samtidig får cisplatin), begyndende 1 uge før strålebehandling og fortsætter indtil 2 uger efter afslutning af strålebehandling i i alt ca. 9 uger.
Arm II: Patienter modtager strålebehandling som i arm I. Patienter får også placebo SC efter samme tidsplan som GM-CSF i arm I.

Livskvalitet vurderes ved baseline og derefter ved 3, 6 og 12 måneder.

Patienterne følges efter 3, 6 og 11 måneder.

PROJEKTERET OPSLAG: I alt 126 patienter (63 pr. arm) vil blive optjent inden for 1,2-1,4 flere år.

Undersøgelsestype

Interventionel

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Tom Baker Cancer Center - Calgary
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute
- New Brunswick
  - Saint John, New Brunswick, Canada, E2L 4L2
    - Saint John Regional Hospital
- Newfoundland and Labrador
  - St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
    - Newfoundland Cancer Treatment and Research Foundation
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - Nova Scotia Cancer Centre
- Ontario
  - Hamilton, Ontario, Canada, L8V 5C2
    - Cancer Care Ontario-Hamilton Regional Cancer Centre
  - Kingston, Ontario, Canada, K7L 5P9
    - Kingston Regional Cancer Centre
  - London, Ontario, Canada, N6A 4L6
    - Cancer Care Ontario-London Regional Cancer Centre
  - Ottawa, Ontario, Canada, K1H 1C4
    - Ottawa Regional Cancer Centre
  - Sudbury, Ontario, Canada, P3E 5J1
    - Northeastern Ontario Regional Cancer Centre, Sudbury
  - Thunder Bay, Ontario, Canada, P7A 7T1
    - Northwestern Ontario Regional Cancer Centre, Thunder Bay
  - Toronto, Ontario, Canada, M4N 3M5
    - Toronto Sunnybrook Regional Cancer Centre
  - Toronto, Ontario, Canada, M5G 2M9
    - Princess Margaret Hospital
- Quebec
  - Fleurimont, Quebec, Canada, J1H 5N4
    - CHUS-Hopital Fleurimont
  - Montreal, Quebec, Canada, H2W 1S6
    - McGill University
  - Montreal, Quebec, Canada, H2L-4M1
    - Centre Hospitalier de l'Université de Montréal
  - Quebec City, Quebec, Canada, G1R 2J6
    - Centre Hospitalier Universitaire de Quebec
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T 7T1
    - Allan Blair Cancer Centre
  - Saskatoon, Saskatchewan, Canada, S7N 4H4
    - Saskatoon Cancer Centre
Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35294-3300
    - University of Alabama at Birmingham Comprehensive Cancer Center
  - Huntsville, Alabama, Forenede Stater, 35801
    - Comprehensive Cancer Institute of Huntsville
  - Huntsville, Alabama, Forenede Stater, 35801-4470
    - Huntsville Hospital System
  - Mobile, Alabama, Forenede Stater, 36688
    - MBCCOP - Gulf Coast
  - Montgomery, Alabama, Forenede Stater, 36106-2801
    - Alabama Oncology, LLC
  - Tuscaloosa, Alabama, Forenede Stater, 35401
    - Radiation Oncology Associates of West Alabama
- Arizona
  - Phoenix, Arizona, Forenede Stater, 85013
    - Foundation for Cancer Research and Education
- California
  - Concord, California, Forenede Stater, 94524-4110
    - Mount Diablo Medical Center
  - Duarte, California, Forenede Stater, 91010-3000
    - Cancer Center and Beckman Research Institute, City of Hope
  - Fresno, California, Forenede Stater, 93720
    - California Cancer Center
  - Fresno, California, Forenede Stater, 93720
    - Saint Agnes Cancer Center
  - Greenbrae, California, Forenede Stater, 94904
    - Sutter Health West Cancer Research Group
  - Loma Linda, California, Forenede Stater, 92354
    - Loma Linda University Medical Center
  - Long Beach, California, Forenede Stater, 90822
    - Veterans Affairs Medical Center - Long Beach
  - Los Angeles, California, Forenede Stater, 90095-1781
    - Jonsson Comprehensive Cancer Center, UCLA
  - Los Angeles, California, Forenede Stater, 90033-0804
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Oakland, California, Forenede Stater, 94609-3305
    - CCOP - Bay Area Tumor Institute
  - Pasadena, California, Forenede Stater, 91105
    - Huntington Cancer Center
  - Pomona, California, Forenede Stater, 91767
    - Cancer Care Center
  - Sacramento, California, Forenede Stater, 95816
    - Radiation Oncology Center - Sacramento
  - San Diego, California, Forenede Stater, 92101-1492
    - Radiation Medical Group, Inc.
  - San Francisco, California, Forenede Stater, 94143-0128
    - UCSF Cancer Center and Cancer Research Institute
  - San Jose, California, Forenede Stater, 95128
    - O'Connor Hospital
  - Santa Rosa, California, Forenede Stater, 95403
    - CCOP - Santa Rosa Memorial Hospital
  - Stockton, California, Forenede Stater, 95204
    - St. Joseph's Regional Health System
  - Travis Air Force Base, California, Forenede Stater, 94535
    - David Grant Medical Center
- Colorado
  - Colorado Springs, Colorado, Forenede Stater, 80909
    - Memorial Hospital Cancer Center
  - Denver, Colorado, Forenede Stater, 80010
    - University of Colorado Cancer Center
  - Grand Junction, Colorado, Forenede Stater, 81502
    - Saint Mary's Hospital and Medical Center
- Delaware
  - Wilmington, Delaware, Forenede Stater, 19899
    - CCOP - Christiana Care Health Services
- Florida
  - Gainesville, Florida, Forenede Stater, 32610-0296
    - University of Florida Health Science Center
  - Jacksonville, Florida, Forenede Stater, 32207
    - Edna Williams Cancer Treatment Center
  - Melbourne, Florida, Forenede Stater, 32901
    - Health First Holmes Regional Medical Center
  - Miami, Florida, Forenede Stater, 33136
    - Sylvester Cancer Center, University of Miami
  - Miami, Florida, Forenede Stater, 33176-2197
    - Baptist Hospital of Miami
  - Miami, Florida, Forenede Stater, 33125
    - Veterans Affairs Medical Center - Miami
  - Miami Beach, Florida, Forenede Stater, 33140
    - CCOP - Mount Sinai Medical Center
  - Orlando, Florida, Forenede Stater, 32806
    - MD Anderson Cancer Center Orlando
  - Panama City, Florida, Forenede Stater, 32405-4587
    - Gulf Coast Cancer Treatment Center
  - Panama City, Florida, Forenede Stater, 32401
    - Bay Medical Center
  - Sarasota, Florida, Forenede Stater, 34233
    - Sarasota Radiation and Medical Oncology Center
  - Tallahassee, Florida, Forenede Stater, 32308
    - Tallahassee Memorial HealthCare
  - Tampa, Florida, Forenede Stater, 33612-9497
    - H. Lee Moffitt Cancer Center and Research Institute
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30322
    - Emory University Hospital - Atlanta
  - Atlanta, Georgia, Forenede Stater, 30342-1701
    - CCOP - Atlanta Regional
  - Columbus, Georgia, Forenede Stater, 31902
    - Medical Center/John B. Amos Community Cancer Center
  - Rome, Georgia, Forenede Stater, 30165
    - Regional Radiation Oncology Center at Rome
- Hawaii
  - Honolulu, Hawaii, Forenede Stater, 96813
    - MBCCOP - Hawaii
- Illinois
  - Arlington Heights, Illinois, Forenede Stater, 60005
    - Northwest Community Hospital
  - Chicago, Illinois, Forenede Stater, 60611
    - Northwestern Memorial Hospital
  - Decatur, Illinois, Forenede Stater, 62526
    - CCOP - Central Illinois
  - Harvey, Illinois, Forenede Stater, 60426
    - Ingalls Memorial Hospital
  - Maywood, Illinois, Forenede Stater, 60153
    - Loyola University Medical Center
  - Park Ridge, Illinois, Forenede Stater, 60068
    - Lutheran General Cancer Care Center
  - Peoria, Illinois, Forenede Stater, 61636
    - Methodist Medical Center of Illinois
- Indiana
  - Anderson, Indiana, Forenede Stater, 46016
    - St. John's Medical Center
  - Bloomington, Indiana, Forenede Stater, 47402
    - Bloomington Hospital
  - Indianapolis, Indiana, Forenede Stater, 46202
    - Veterans Affairs Medical Center - Indianapolis (Roudebush)
  - Indianapolis, Indiana, Forenede Stater, 46206-1367
    - Clarian Health Partners Inc.
  - Indianapolis, Indiana, Forenede Stater, 46219
    - Regional Cancer Center
  - Lafayette, Indiana, Forenede Stater, 47904
    - Oncology Institute of Greater Lafayette
  - Muncie, Indiana, Forenede Stater, 47303-3499
    - Ball Memorial Hospital
  - South Bend, Indiana, Forenede Stater, 46601
    - CCOP - Northern Indiana CR Consortium
- Iowa
  - Dubuque, Iowa, Forenede Stater, 52001
    - Wendt Regional Cancer Center of Finley Hospital
- Kentucky
  - Lexington, Kentucky, Forenede Stater, 40536-0084
    - Albert B. Chandler Medical Center, University of Kentucky
  - Lexington, Kentucky, Forenede Stater, 40503
    - Central Baptist Hospital
  - Lexington, Kentucky, Forenede Stater, 40504
    - Lexington Clinic Cancer Center
  - Louisville, Kentucky, Forenede Stater, 40202
    - James Graham Brown Cancer Center
  - Louisville, Kentucky, Forenede Stater, 40215
    - Louisville Radiation Oncology
  - Madisonville, Kentucky, Forenede Stater, 42431
    - Merle M. Mahr Cancer Center
- Louisiana
  - Baton Rouge, Louisiana, Forenede Stater, 70809
    - Mary Bird Perkins Cancer Center
  - New Orleans, Louisiana, Forenede Stater, 70112
    - Tulane University School of Medicine
  - New Orleans, Louisiana, Forenede Stater, 70121
    - CCOP - Ochsner
  - New Orleans, Louisiana, Forenede Stater, 70112
    - MBCCOP - LSU Health Sciences Center
- Maine
  - Portland, Maine, Forenede Stater, 04102
    - Maine Medical Center
- Maryland
  - Annapolis, Maryland, Forenede Stater, 21401
    - Anne Arundel Oncology Center
  - Baltimore, Maryland, Forenede Stater, 21231-2410
    - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  - Baltimore, Maryland, Forenede Stater, 21225
    - Sinai Hospital of Baltimore
  - Baltimore, Maryland, Forenede Stater, 21204
    - Greater Baltimore Medical Center and Cancer Center
  - Baltimore, Maryland, Forenede Stater, 21225
    - Harbor Hospital Center
  - Salisbury, Maryland, Forenede Stater, 21801
    - Peninsula Regional Medical Center
- Massachusetts
  - Hyannis, Massachusetts, Forenede Stater, 02601
    - Cape Cod Hospital
  - Jamaica Plain, Massachusetts, Forenede Stater, 02130
    - Veterans Affairs Medical Center - Boston (Jamaica Plain)
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48109-0752
    - University Of Michigan Comprehensive Cancer Center
  - Ann Arbor, Michigan, Forenede Stater, 48106
    - CCOP - Ann Arbor Regional
  - Detroit, Michigan, Forenede Stater, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, Forenede Stater, 48201-1379
    - Barbara Ann Karmanos Cancer Institute
  - Flint, Michigan, Forenede Stater, 48503
    - Hurley Medical Center
  - Flint, Michigan, Forenede Stater, 48432
    - McLaren Regional Cancer Center
  - Kalamazoo, Michigan, Forenede Stater, 49007-3731
    - CCOP - Kalamazoo
  - Marquette, Michigan, Forenede Stater, 49855
    - Marquette General Hospital
  - Midland, Michigan, Forenede Stater, 48670
    - MidMichigan Medical Center - Midland
  - Royal Oak, Michigan, Forenede Stater, 48073
    - William Beaumont Hospital
  - Troy, Michigan, Forenede Stater, 48098
    - William Beaumont Hospital - Troy
- Minnesota
  - Rochester, Minnesota, Forenede Stater, 55905
    - Mayo Clinic Cancer Center
  - Saint Louis Park, Minnesota, Forenede Stater, 55416
    - CCOP - Metro-Minnesota
- Missouri
  - Columbia, Missouri, Forenede Stater, 65203
    - Ellis Fischel Cancer Center - Columbia
  - Kansas City, Missouri, Forenede Stater, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, Forenede Stater, 63110-0250
    - St. Louis University Health Sciences Center
  - Saint Louis, Missouri, Forenede Stater, 63108
    - Mallinckrodt Institute of Radiology
  - Springfield, Missouri, Forenede Stater, 65807
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, Forenede Stater, 65807
    - Cancer Research for the Ozarks
- Montana
  - Billings, Montana, Forenede Stater, 59101
    - CCOP - Montana Cancer Consortium
- Nebraska
  - Omaha, Nebraska, Forenede Stater, 68114
    - Methodist Cancer Center - Omaha
  - Omaha, Nebraska, Forenede Stater, 68106
    - CCOP - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, Forenede Stater, 68198-7460
    - Nebraska Health System
- Nevada
  - Las Vegas, Nevada, Forenede Stater, 89106
    - CCOP - Southern Nevada Cancer Research Foundation
- New Hampshire
  - Lebanon, New Hampshire, Forenede Stater, 03756-0002
    - Norris Cotton Cancer Center
  - Manchester, New Hampshire, Forenede Stater, 03103
    - Elliot Regional Cancer Center
- New Jersey
  - East Orange, New Jersey, Forenede Stater, 07018-1095
    - Veterans Affairs Medical Center - East Orange
  - Edison, New Jersey, Forenede Stater, 08818
    - John F. Kennedy Medical Center
  - Elizabeth, New Jersey, Forenede Stater, 07201
    - Trinitas Hospital - Jersey Street Campus
  - Long Branch, New Jersey, Forenede Stater, 07740-6395
    - Monmouth Medical Center
  - Millville, New Jersey, Forenede Stater, 08332
    - South Jersey Regional Cancer Center
  - Mount Holly, New Jersey, Forenede Stater, 08060
    - Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
  - New Brunswick, New Jersey, Forenede Stater, 08903
    - Cancer Institute Of New Jersey
  - Newark, New Jersey, Forenede Stater, 07112
    - Newark Beth Israel Medical Center
  - Pomona, New Jersey, Forenede Stater, 08240
    - Atlantic City Medical Center
  - Ridgewood, New Jersey, Forenede Stater, 07450
    - Valley Hospital
  - Toms River, New Jersey, Forenede Stater, 08755
    - Community Medical Center
  - Trenton, New Jersey, Forenede Stater, 08629
    - St. Francis Medical Center
  - Warren, New Jersey, Forenede Stater, 07059
    - Associated Radiologists, P.A.
- New Mexico
  - Albuquerque, New Mexico, Forenede Stater, 87109
    - Radiation Oncology Associates of Albuquerque
- New York
  - Albany, New York, Forenede Stater, 12208
    - Cancer Center of Albany Medical Center
  - Binghamton, New York, Forenede Stater, 13905
    - Lourdes Regional Cancer Center
  - Brooklyn, New York, Forenede Stater, 11203
    - State University of New York Health Science Center at Brooklyn
  - Brooklyn, New York, Forenede Stater, 11215-3609
    - New York Methodist Hospital
  - Clifton Springs, New York, Forenede Stater, 14432
    - Finger Lakes Radiation Oncology Center
  - Manhasset, New York, Forenede Stater, 11030
    - CCOP - North Shore University Hospital
  - New York, New York, Forenede Stater, 10021
    - Memorial Sloan-Kettering Cancer Center
  - New York, New York, Forenede Stater, 10032
    - Herbert Irving Comprehensive Cancer Center
  - Plattsburgh, New York, Forenede Stater, 12901
    - Champlain Valley Physicians Hospital Medical Center
  - Poughkeepsie, New York, Forenede Stater, 12601
    - Vassar Brothers Hospital
  - Rochester, New York, Forenede Stater, 14642
    - University of Rochester Cancer Center
  - Setauket, New York, Forenede Stater, 11733
    - North Shore Radiation Oncology
  - Syracuse, New York, Forenede Stater, 13210
    - State University of New York - Upstate Medical University
  - Syracuse, New York, Forenede Stater, 13217
    - CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  - Yonkers, New York, Forenede Stater, 10701
    - Riverhill Radiation Oncology
- North Carolina
  - Chapel Hill, North Carolina, Forenede Stater, 27599-7295
    - Lineberger Comprehensive Cancer Center, UNC
  - Concord, North Carolina, Forenede Stater, 28025
    - Northeast Medical Center
  - Greenville, North Carolina, Forenede Stater, 27858-4354
    - East Carolina University School of Medicine
  - Raleigh, North Carolina, Forenede Stater, 27607
    - Rex Healthcare
  - Winston-Salem, North Carolina, Forenede Stater, 27104-4241
    - CCOP - Southeast Cancer Control Consortium
  - Winston-Salem, North Carolina, Forenede Stater, 27157-1082
    - Comprehensive Cancer Center at Wake Forest University
- North Dakota
  - Minot, North Dakota, Forenede Stater, 58701
    - Trinity Cancer Care Center
- Ohio
  - Akron, Ohio, Forenede Stater, 44302
    - Akron General Medical Center
  - Akron, Ohio, Forenede Stater, 44309
    - Akron City Hospital
  - Cincinnati, Ohio, Forenede Stater, 45219
    - Christ Hospital
  - Cincinnati, Ohio, Forenede Stater, 45267-0502
    - Barrett Cancer Center, The University Hospital
  - Cleveland, Ohio, Forenede Stater, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland, Ohio, Forenede Stater, 44106
    - University Hospitals of Cleveland
  - Cleveland, Ohio, Forenede Stater, 44106-5065
    - Ireland Cancer Center
  - Cleveland, Ohio, Forenede Stater, 44195-5044
    - Cleveland Clinic Foundation
  - Columbus, Ohio, Forenede Stater, 43210-1240
    - Arthur G. James Cancer Hospital - Ohio State University
  - Columbus, Ohio, Forenede Stater, 43206
    - CCOP - Columbus
  - Kettering, Ohio, Forenede Stater, 45429
    - CCOP - Dayton
  - Toledo, Ohio, Forenede Stater, 43623-3456
    - CCOP - Toledo Community Hospital Oncology Program
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73190
    - University of Oklahoma Health Sciences Center
  - Oklahoma City, Oklahoma, Forenede Stater, 73101
    - St. Anthony Hospital
  - Tulsa, Oklahoma, Forenede Stater, 74104
    - St. John Health System
- Oregon
  - Portland, Oregon, Forenede Stater, 97213
    - CCOP - Columbia River Program
- Pennsylvania
  - Allentown, Pennsylvania, Forenede Stater, 18103
    - LeHigh Valley Hospital
  - Bethlehem, Pennsylvania, Forenede Stater, 18015
    - St. Luke's Hospital Regional Cancer Center
  - Danville, Pennsylvania, Forenede Stater, 17822-2001
    - Geisinger Medical Center
  - Darby, Pennsylvania, Forenede Stater, 19023
    - Mercy Fitzgerald Hospital
  - Drexel Hill, Pennsylvania, Forenede Stater, 19026
    - Delaware County Memorial Hospital
  - East Stroudsburg, Pennsylvania, Forenede Stater, 18301
    - Pocono Cancer Center
  - Hershey, Pennsylvania, Forenede Stater, 17033-0850
    - Milton S. Hershey Medical Center
  - Philadelphia, Pennsylvania, Forenede Stater, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, Forenede Stater, 19104
    - Veterans Affairs Medical Center - Philadelphia
  - Philadelphia, Pennsylvania, Forenede Stater, 19141
    - Albert Einstein Cancer Center
  - Philadelphia, Pennsylvania, Forenede Stater, 19104-4283
    - University of Pennsylvania Cancer Center
  - Philadelphia, Pennsylvania, Forenede Stater, 19107-5541
    - Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
  - Pittsburgh, Pennsylvania, Forenede Stater, 15224
    - Western Pennsylvania Hospital
  - Pittsburgh, Pennsylvania, Forenede Stater, 15213-3489
    - University of Pittsburgh Cancer Institute
  - Pittsburgh, Pennsylvania, Forenede Stater, 15219
    - Mercy Hospital of Pittsburgh
  - Reading, Pennsylvania, Forenede Stater, 19612-6052
    - Reading Hospital and Medical Center
  - Scranton, Pennsylvania, Forenede Stater, 18501
    - Mercy Hospital Cancer Center - Scranton
  - Wilkes-Barre, Pennsylvania, Forenede Stater, 18764
    - Wilkes Barre General Hospital
  - York, Pennsylvania, Forenede Stater, 17315
    - York Hospital
- Rhode Island
  - Providence, Rhode Island, Forenede Stater, 02908-4735
    - Roger Williams Medical Center/BUSM
- South Carolina
  - Greenville, South Carolina, Forenede Stater, 29615
    - CCOP - Greenville
  - Spartanburg, South Carolina, Forenede Stater, 29303
    - CCOP - Upstate Carolina
- South Dakota
  - Rapid City, South Dakota, Forenede Stater, 57709
    - Rapid City Regional Hospital
- Tennessee
  - 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
  - Amarillo, Texas, Forenede Stater, 79106
    - Harrington Cancer Center
  - Galveston, Texas, Forenede Stater, 77555-0209
    - University of Texas Medical Branch
  - 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
- Utah
  - 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
  - Burlington, Vermont, Forenede Stater, 05401-3498
    - Vermont Cancer Center
- Virginia
  - Charlottesville, Virginia, Forenede Stater, 22908
    - Cancer Center at the University of Virginia
  - Harrisonburg, Virginia, Forenede Stater, 22801
    - RMH Regional Cancer Center
  - 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
- Washington
  - Seattle, Washington, Forenede Stater, 98111
    - Virginia Mason Medical Center
  - Spokane, Washington, Forenede Stater, 99210-0248
    - Deaconess Medical Center
  - Yakima, Washington, Forenede Stater, 98902
    - Yakima Valley Memorial Hospital
- West Virginia
  - Wheeling, West Virginia, Forenede Stater, 26003
    - Schiffler Cancer Center
- Wisconsin
  - Green Bay, Wisconsin, Forenede Stater, 54307-3508
    - St. Vincent Hospital
  - Green Bay, Wisconsin, Forenede Stater, 54301
    - CCOP - Green Bay
  - La Crosse, Wisconsin, Forenede Stater, 54601
    - Gundersen Lutheran Medical Foundation
  - Madison, Wisconsin, Forenede Stater, 53792-6164
    - 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, 53211
    - Columbia Hospital
  - Milwaukee, Wisconsin, Forenede Stater, 53215
    - St. Luke's Medical Center
  - Racine, Wisconsin, Forenede Stater, 53405
    - All Saints Cancer Center
  - Waukesha, Wisconsin, Forenede Stater, 53188
    - Waukesha Memorial Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Barn
Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

SYGDOMS KARAKTERISTIKA:

Histologisk bekræftet hoved- og halskarcinom med planlagt ekstern strålebehandling til at omfatte 50 % af oropharynx, mundhule eller begge dele]
Planlagt ekstern strålebehandling af 60-70 Gy total dosis til den primære tumor eller standardporte for en ukendt primær tumor
Nakkemetastaser fra en ukendt primær tilladt, hvis strålebehandling er planlagt til mindst 50 % af spytkirtlen ved en dosis på mindst 50 Gy
Ingen T1-T2 glottiske tumorer
Ingen resterende oral/orofaryngeal skade fra tidligere kemoterapi

PATIENT KARAKTERISTIKA:

Alder:

Ikke specificeret

Ydeevnestatus:

Karnofsky 60-100 %

Forventede levealder:

Ikke specificeret

Hæmatopoietisk:

Ikke specificeret

Hepatisk:

Ikke specificeret

Nyre:

Ikke specificeret

Andet:

Ikke gravid eller ammende
Negativ graviditetstest
Fertile patienter skal bruge effektiv prævention
Ingen allergi eller idiosynkratisk respons på sargramostim (GM-CSF)
HIV negativ

FORUDSÆTNING SAMTYDLIG TERAPI:

Biologisk terapi:

Ikke specificeret

Kemoterapi:

Se Sygdomskarakteristika
Ingen samtidig kemoterapi ud over cisplatin

Endokrin terapi:

Ikke specificeret

Strålebehandling:

Se Sygdomskarakteristika
Ingen forudgående strålebehandling af hoved og nakke

Kirurgi:

Ikke specificeret

Andet:

Ingen samtidig tilmelding til andre RTOG hoved- og halsstudier
Ingen samtidig mundplejemedicin (f.eks. amifostin, klorhexidrin gluconat, sucralfat eller benzydamin HCl) under undersøgelsesstrålebehandling
Ingen samtidig selektiv dekontaminering af mundhulen (f.eks. IB-367) under undersøgelsesstrålebehandling

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
Maskning: Dobbelt

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Radiation Therapy Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

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

Ryu JK, Swann S, LeVeque F, Scarantino CW, Johnson D, Chen A, Fortin A, Pollock J, Kim H, Ang KK. The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: a double-blind placebo-controlled prospective phase III study by Radiation Therapy Oncology Group 9901. Int J Radiat Oncol Biol Phys. 2007 Mar 1;67(3):643-50. doi: 10.1016/j.ijrobp.2006.09.043.

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. oktober 2000

Primær færdiggørelse (Faktiske)

1. marts 2004

Datoer for studieregistrering

Først indsendt

6. januar 2001

Først indsendt, der opfyldte QC-kriterier

4. juni 2003

Først opslået (Skøn)

5. juni 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. november 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. november 2013

Sidst verificeret

1. november 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

RTOG-9901
CDR0000068406
NCI-P00-0177

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 .