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Stråleterapi med eller uden epoetin alfa til behandling af anæmiske patienter med hoved- og halskræft

21. oktober 2020 opdateret af: Radiation Therapy Oncology Group

Et randomiseret fase III-forsøg for at vurdere effekten af erythropoietin på lokal-regional kontrol hos anæmiske patienter behandlet med strålebehandling for karcinom i hoved og nakke

RATIONALE: Strålebehandling bruger højenergi-røntgenstråler til at beskadige tumorceller. Epoetin alfa kan stimulere produktionen af røde blodlegemer og behandle anæmi hos patienter med hoved- og halskræft. Det vides endnu ikke, om strålebehandling med epoetin alfa er mere effektiv end strålebehandling alene til behandling af anæmiske patienter med hoved- og halskræft.

FORMÅL: Randomiseret fase III-forsøg til at sammenligne effektiviteten af strålebehandling med eller uden epoetin alfa til behandling af anæmiske patienter, som har hoved- og halskræft.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

MÅL:

Primær

Bestem, om epoetin alfa givet under definitiv strålebehandling eller kemoradioterapi forbedrer den lokale-regionale kontrolrate hos anæmiske patienter med planocellulært karcinom i hoved og hals.

Sekundær

Bestem, om dette lægemiddel forbedrer overlevelsen i denne patientpopulation.
Identificer mønstre i første svigt hos disse patienter.
Bestem, om der er en signifikant stigning i hæmoglobinniveauet mellem baselineværdien og værdien 28 dage efter start af epoetin alfa hos disse patienter.
Vurder toksiciteten af dette regime hos disse patienter.

OVERSIGT: Dette er en randomiseret undersøgelse. Patienterne stratificeres efter stadie (I/II vs III/IV uden kemoterapi vs III/IV med kemoterapi), hæmoglobinniveau før behandling (9,0 til mindre end 11,5 g/dL mod 11,5 til 13,5 g/dL) og køn. Patienterne randomiseres til en af to behandlingsarme.

Arm I: Patienter med stadium I eller II sygdom gennemgår strålebehandling én gang dagligt i 6-7 uger. Patienter med stadium III eller IV sygdom gennemgår strålebehandling én gang dagligt i 3,5 uger og derefter to gange dagligt (6 timers mellemrum) i 2,5 uger i i alt 6 uger.
Arm II: Patienter gennemgår strålebehandling som i arm I. Begyndende 7-10 dage før strålebehandling får patienterne epoetin alfa subkutant én gang om ugen indtil afslutningen af strålebehandlingen.

Patienter med stadium III/IV sygdom kan samtidig modtage cisplatin IV over 1-2 timer på dag 1 og 22 af strålebehandling.

Patienterne følges hver 3. måned i 2 år, hver 6. måned i 3 år og derefter årligt.

PROJEKTERET TILSLUTNING: I alt 372 patienter (186 pr. arm) vil blive akkumuleret til denne undersøgelse inden for 3,5 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
  - Moncton, New Brunswick, Canada, E1C 8X3
    - Doctor Leon Richard Oncology Centre
  - 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 4MI
    - Centre Hospitalier de l'Universite de Montreal
  - 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, 35807
    - Huntsville Hospital System
  - Mobile, Alabama, Forenede Stater, 36688
    - MBCCOP - Gulf Coast
  - Montgomery, Alabama, Forenede Stater, 36106-3657
    - Alabama Oncology, LLC
  - Tuscaloosa, Alabama, Forenede Stater, 35401
    - DCH Cancer Treatment Center
- Arizona
  - Phoenix, Arizona, Forenede Stater, 85013
    - Foundation for Cancer Research and Education
- California
  - Burbank, California, Forenede Stater, 91505
    - Providence Saint Joseph Medical Center - Burbank
  - Concord, California, Forenede Stater, 94524-4110
    - Mount Diablo Medical Center
  - Duarte, California, Forenede Stater, 91010-3000
    - City of Hope Comprehensive Cancer Center
  - Fresno, California, Forenede Stater, 93720
    - California Cancer Center
  - Fresno, California, Forenede Stater, 93720
    - Saint Agnes Cancer Center
  - Greenbrae, California, Forenede Stater, 94904
    - Sutter Health Western Division 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, 90033-0804
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Los Angeles, California, Forenede Stater, 90095-1714
    - Jonsson Comprehensive Cancer Center, UCLA
  - Oakland, California, Forenede Stater, 94609-3305
    - CCOP - Bay Area Tumor Institute
  - Pasadena, California, Forenede Stater, 91105
    - Huntington Cancer Center
  - Pomona, California, Forenede Stater, 91767
    - Robert and Beverly Lewis Family Cancer Care Center
  - Sacramento, California, Forenede Stater, 95816
    - Radiation Oncology Center - Sacramento
  - San Diego, California, Forenede Stater, 92134-3202
    - Naval Medical Center - San Diego
  - San Diego, California, Forenede Stater, 92101
    - Radiation Medical Group, Incorporated
  - San Francisco, California, Forenede Stater, 94143-0128
    - UCSF Comprehensive Cancer Center
  - San Jose, California, Forenede Stater, 95128
    - O'Connor Hospital
  - Santa Rosa, California, Forenede Stater, 95403
    - CCOP - Santa Rosa Memorial Hospital
  - Torrance, California, Forenede Stater, 90505
    - Torrance Memorial Medical Center
  - 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
  - Denver, Colorado, Forenede Stater, 80224
    - CCOP - Colorado Cancer Research Program, Incorporated
  - Grand Junction, Colorado, Forenede Stater, 81502-1628
    - Saint Mary's Hospital and Medical Center
- Connecticut
  - New Haven, Connecticut, Forenede Stater, 06520-8040
    - Yale Comprehensive Cancer Center
- Delaware
  - Newark, Delaware, Forenede Stater, 19713
    - CCOP - Christiana Care Health Services
- District of Columbia
  - Washington, District of Columbia, Forenede Stater, 20016
    - Sibley Memorial Hospital
- Florida
  - Fort Myers, Florida, Forenede Stater, 33901-8082
    - 21st Century Oncology - Fort Myers
  - Gainesville, Florida, Forenede Stater, 32610-0385
    - University of Florida Health Science Center
  - Jacksonville, Florida, Forenede Stater, 32207
    - Florida Radiation Oncology Group
  - Melbourne, Florida, Forenede Stater, 32901-3276
    - Holmes Regional Medical Center
  - Miami, Florida, Forenede Stater, 33136
    - Sylvester Cancer Center, University of Miami
  - Miami, Florida, Forenede Stater, 33125
    - Veterans Affairs Medical Center - Miami
  - Miami, Florida, Forenede Stater, 33256-2110
    - Baptist Hospital of Miami
  - Miami Beach, Florida, Forenede Stater, 33140
    - CCOP - Mount Sinai Medical Center
  - Orlando, Florida, Forenede Stater, 32806-2134
    - 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, 31901
    - 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
  - Peoria, Illinois, Forenede Stater, 61602
    - CCOP - Scott and White Hospital
- 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
    - Community Regional Cancer Care
  - 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
  - Edgewood, Kentucky, Forenede Stater, 41017
    - St. Elizabeth Medical Center
  - Lexington, Kentucky, Forenede Stater, 40503
    - Central Baptist Hospital
  - Lexington, Kentucky, Forenede Stater, 40504
    - Cancer Center at Lexington Clinic
  - Lexington, Kentucky, Forenede Stater, 40536-0293
    - Albert B. Chandler Medical Center, University of Kentucky
  - 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, 70121
    - CCOP - Ochsner
  - New Orleans, Louisiana, Forenede Stater, 70112
    - MBCCOP - LSU Health Sciences Center
  - New Orleans, Louisiana, Forenede Stater, 70112-2699
    - Tulane University School of Medicine
- 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, 21215
    - Sinai Hospital of Baltimore
  - Baltimore, Maryland, Forenede Stater, 21201
    - Marlene and Stewart Greenebaum Cancer Center, University of Maryland
  - Baltimore, Maryland, Forenede Stater, 21204
    - Greater Baltimore Medical Center and Cancer Center
  - Baltimore, Maryland, Forenede Stater, 21215-1290
    - Harbor Hospital Center
  - Baltimore, Maryland, Forenede Stater, 21229
    - St. Agnes Cancer Center
  - Salisbury, Maryland, Forenede Stater, 21801
    - Peninsula Regional Medical Center
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02118
    - Boston Medical Center
  - Boston, Massachusetts, Forenede Stater, 02114
    - Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  - Hyannis, Massachusetts, Forenede Stater, 02601
    - Cape Cod Hospital
  - Jamaica Plain, Massachusetts, Forenede Stater, 02130
    - Veterans Affairs Medical Center - Boston (Jamaica Plain)
  - Peabody, Massachusetts, Forenede Stater, 01960
    - NSMC Cancer Center
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Ann Arbor, Michigan, Forenede Stater, 48109-0010
    - University of Michigan Comprehensive Cancer Center
  - 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, 48532-3685
    - 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, 48073-6769
    - CCOP - Beaumont
  - Royal Oak, Michigan, Forenede Stater, 48073
    - William Beaumont Hospital
  - Troy, Michigan, Forenede Stater, 48098
    - William Beaumont Hospital - Troy
- Minnesota
  - Minneapolis, Minnesota, Forenede Stater, 55455
    - Fairview University Medical Center
  - Rochester, Minnesota, Forenede Stater, 55905-0001
    - 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, 68106
    - CCOP - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, Forenede Stater, 68114
    - Methodist Hospital Cancer Center - Omaha
  - Omaha, Nebraska, Forenede Stater, 68198-7460
    - Nebraska Health System
- Nevada
  - Las Vegas, Nevada, Forenede Stater, 89106
    - CCOP - Southern Nevada Cancer Research Foundation
  - Las Vegas, Nevada, Forenede Stater, 89109
    - Comprehensive Cancer Centers of Nevada
- 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, 07019
    - 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 Virtua Health Cancer Program at Virtua Memorial Hospital
  - 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
  - Princeton, New Jersey, Forenede Stater, 08540
    - Medical Center of Princeton
  - 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
  - Brooklyn, New York, Forenede Stater, 11203
    - State University of New York Health Science Center at Brooklyn
  - Brooklyn, New York, Forenede Stater, 11215
    - New York Methodist Hospital
  - Buffalo, New York, Forenede Stater, 14263-0001
    - Roswell Park Cancer Institute
  - 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, 10003
    - Beth Israel Medical 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
  - Rochester, New York, Forenede Stater, 14642
    - James P. Wilmot Cancer Center
  - 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
  - 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, 44304
    - Akron City Hospital
  - Cincinnati, Ohio, Forenede Stater, 45219
    - Christ Hospital
  - Cincinnati, Ohio, Forenede Stater, 45219
    - Barrett Cancer Center
  - 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
  - Columbus, Ohio, Forenede Stater, 43210-1240
    - Arthur G. James Cancer Hospital - Ohio State University
  - Columbus, Ohio, Forenede Stater, 43206
    - CCOP - Columbus
  - Dayton, Ohio, Forenede Stater, 45429
    - CCOP - Dayton
  - Parma, Ohio, Forenede Stater, 44129
    - Parma Community General Hospital
  - Toledo, Ohio, Forenede Stater, 43623-3456
    - CCOP - Toledo Community Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73104
    - University of Oklahoma Health Sciences Center
  - Oklahoma City, Oklahoma, Forenede Stater, 73101
    - St. Anthony Hospital
  - Tulsa, Oklahoma, Forenede Stater, 74136
    - CCOP - Oklahoma
  - Tulsa, Oklahoma, Forenede Stater, 74104
    - St. John Health System
- Oregon
  - Portland, Oregon, Forenede Stater, 97225
    - CCOP - Columbia River Oncology Program
- Pennsylvania
  - Abington, Pennsylvania, Forenede Stater, 19001
    - Abington Memorial Hospital
  - Allentown, Pennsylvania, Forenede Stater, 18105
    - Lehigh Valley Hospital
  - Bethlehem, Pennsylvania, Forenede Stater, 18015
    - St. Luke's Hospital 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, 19104-4283
    - Abramson Cancer Center of the University of Pennsylvania
  - Philadelphia, Pennsylvania, Forenede Stater, 19104
    - Veterans Affairs Medical Center - Philadelphia
  - Philadelphia, Pennsylvania, Forenede Stater, 19107-5541
    - Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
  - Philadelphia, Pennsylvania, Forenede Stater, 19141-3098
    - Albert Einstein Cancer Center
  - Pittsburgh, Pennsylvania, Forenede Stater, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, Forenede Stater, 15224
    - Western Pennsylvania Hospital
  - Pittsburgh, Pennsylvania, Forenede Stater, 15219
    - Mercy Hospital of Pittsburgh
  - Pittsburgh, Pennsylvania, Forenede Stater, 15236
    - University of Pittsburgh Cancer Institute
  - 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
  - Wynnewood, Pennsylvania, Forenede Stater, 19096
    - CCOP - MainLine Health
  - York, Pennsylvania, Forenede Stater, 17403
    - York Cancer Center
- 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, 38301-3956
    - Jackson-Madison County General Hospital
  - Memphis, Tennessee, Forenede Stater, 38103
    - University of Tennessee Cancer Institute
  - Nashville, Tennessee, Forenede Stater, 37232-5671
    - Vanderbilt-Ingram Cancer Center
- Texas
  - Amarillo, Texas, Forenede Stater, 79106
    - Harrington Cancer Center
  - Arlington, Texas, Forenede Stater, 76012
    - Arlington 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 Medical Center
  - Lubbock, Texas, Forenede Stater, 79410-1894
    - Joe Arrington Cancer Research and Treatment Center
  - Pasadena, Texas, Forenede Stater, 77504
    - Bayshore Medical Center
  - San Antonio, Texas, Forenede Stater, 78284-7811
    - University of Texas Health Science Center at San Antonio
- Utah
  - Provo, Utah, Forenede Stater, 84604
    - Utah Valley Regional Medical Center - Provo
  - 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
  - Bennington, Vermont, Forenede Stater, 05201
    - Green Mountain Oncology Group
  - Burlington, Vermont, Forenede Stater, 05405-0075
    - 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, 23226
    - Bon Secours - St. Mary's Hospital
  - Richmond, Virginia, Forenede Stater, 23298-0058
    - Massey Cancer Center
- Washington
  - Seattle, Washington, Forenede Stater, 98111
    - Virginia Mason Medical Center
  - Seattle, Washington, Forenede Stater, 98195-6043
    - University of Washington Medical Center
  - Spokane, Washington, Forenede Stater, 99204
    - 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, 54301
    - CCOP - St. Vincent Hospital Cancer Center, Green Bay
  - Green Bay, Wisconsin, Forenede Stater, 54307-3508
    - St. Vincent Hospital
  - La Crosse, Wisconsin, Forenede Stater, 54601
    - Gundersen Lutheran Medical Foundation
  - 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, 53211
    - Columbia Hospital
  - Milwaukee, Wisconsin, Forenede Stater, 53215
    - St. Luke's Medical Center
  - Milwaukee, Wisconsin, Forenede Stater, 53295
    - Veterans Affairs Medical Center - Milwaukee (Zablocki)
  - Milwaukee, Wisconsin, Forenede Stater, 53226
    - Medical College of Wisconsin Cancer Center
  - Racine, Wisconsin, Forenede Stater, 53405
    - All Saints Cancer Center
  - Waukesha, Wisconsin, Forenede Stater, 53188
    - Waukesha Memorial Hospital Regional Cancer Center
Korea, Republikken
- - Gyeonggi, Korea, Republikken, 411-764
    - Jin Soo Lee Practice Inc.

Deltagelseskriterier

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

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

SYGDOMS KARAKTERISTIKA:

Histologisk bekræftet invasiv planocellulært karcinom i hoved og nakke, inklusive karcinom, der opstår fra mundhulen, oropharynx, strubehovedet og hypopharynx
- Stadie I-IV sygdom
- Ingen fjernmetastaser
- Intet karcinom i nasopharynx, næsehule/paranasale bihuler eller spytkirtler
- Intet carcinom in situ uden en identificerbar invasiv komponent
Planlæg for strålebehandling i kontinuerligt forløb
Forudgående kirurgisk udforskning, hvor der fortsat er stor restsygdom tilladt
Forudgående nakkedissektion med eller uden biopsi af primær tumor, men ingen radikal kirurgi for primær tumor tilladt
Anæmi, defineret som hæmoglobin, der ikke er større end 13,5 g/dL for mænd og ikke over 12,5 g/dL for kvinder (transfusion før undersøgelse tilladt)
- Ingen alvorlig anæmi (dvs. hæmoglobin mindre end 9,0 g/dL)
- Ingen anæmi bekræftet at skyldes andre årsager end kronisk sygdom (f.eks. jernmangelanæmi)
Ikke indtastet på andre RTOG hoved- og halsprotokoller

PATIENT KARAKTERISTIKA:

Alder:

18 og derover

Ydeevnestatus:

Zubrod 0-2

Forventede levealder:

Ikke specificeret

Hæmatopoietisk:

Se Sygdomskarakteristika
Stadium III/IV patienter, der samtidig får cisplatin:
- Absolut neutrofiltal mindst 2.000/mm^3
- Blodpladetal mindst 100.000/mm^3

Hepatisk:

Ikke specificeret

Nyre:

Stadium III/IV patienter, der samtidig får cisplatin:
- Kreatinin ikke større end 1,5 mg/dL
- Kreatininclearance mindst 50 ml/min

Kardiovaskulær:

Ingen malign eller dårligt kontrolleret hypertension (f.eks. symptomatisk hypertension eller diastolisk blodtryk på 100 mm Hg eller mere trods antihypertensiv medicin)
Ingen ustabil angina eller anden dårligt kontrolleret hjertesygdom

Andet:

Ikke gravid eller ammende
Negativ graviditetstest
Fertile patienter skal bruge effektiv prævention
Hvis stadium III eller IV sygdom er til stede, villig til at komme til strålebehandling to gange dagligt i de sidste 2,5 ugers behandling
Ingen aktiv infektion, der kræver IV-antibiotika
Ingen uforklarlig feber
Ingen AIDS eller anden historie med medfødt eller erhvervet immundefekt
Ingen andre maligniteter inden for de seneste 3 år undtagen carcinoma in situ eller ikke-melanomatøs hudkræft
Ingen kendt overfølsomhed over for pattedyrcelle-afledte produkter eller over for humant albumin
Ingen akut/subakut sygdom, der ville sandsynliggøre behovet for transfusion

FORUDSÆTNING SAMTYDLIG TERAPI:

Biologisk terapi:

Mindst 4 uger siden anden tidligere cytokinbehandling (f.eks. filgrastim [G-CSF], interleukiner eller interferoner)
Ingen tidligere epoetin alfa
Ingen anden samtidig cytokinbehandling

Kemoterapi:

Ingen forudgående kemoterapi
Samtidig cisplatin, paclitaxel/cisplatin eller paclitaxel/carboplatin til patienter med stadium III/IV sygdom er tilladt

Endokrin terapi:

Ikke specificeret

Strålebehandling:

Se Sygdomskarakteristika
Ingen forudgående strålebehandling af hoved og nakke

Kirurgi:

Se Sygdomskarakteristika

Andet:

Ingen samtidig amifostin
Ingen samtidig transfusion

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret

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)

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

Machtay M, Pajak TF, Suntharalingam M, Shenouda G, Hershock D, Stripp DC, Cmelak AJ, Schulsinger A, Fu KK; Radiation Therapy Oncology Group. Radiotherapy with or without erythropoietin for anemic patients with head and neck cancer: a randomized trial of the Radiation Therapy Oncology Group (RTOG 99-03). Int J Radiat Oncol Biol Phys. 2007 Nov 15;69(4):1008-17. doi: 10.1016/j.ijrobp.2007.04.063. Epub 2007 Aug 23.
Machtay M, Pajak T, Suntharalingam M, et al.: Definitive radiotherapy +/- erythropoietin for squamous cell carcinoma of the head and neck: preliminary report of RTOG 99-03. [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-5, S132, 2004.

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. juni 2000

Primær færdiggørelse (Faktiske)

1. november 2007

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

7. marts 2000

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. oktober 2020

Sidst verificeret