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Vaccineterapi plus strålebehandling til behandling af patienter med ikke-småcellet lungekræft, der er blevet fuldstændigt fjernet i kirurgi

9. august 2013 opdateret af: Radiation Therapy Oncology Group

Fase II-undersøgelse af postoperativ adjuverende immunterapi og stråling hos patienter med fuldstændig resekeret fase II og fase IIIA ikke-småcellet lungekræft

RATIONALE: Vacciner kan få kroppen til at opbygge et immunrespons for at dræbe tumorceller. Strålebehandling bruger højenergi røntgenstråler til at beskadige tumorceller. Kombination af disse to behandlinger kan dræbe flere tumorceller.

FORMÅL: Fase II-forsøg til undersøgelse af effektiviteten af at kombinere vaccinebehandling med strålebehandling til behandling af patienter, der har stadium II eller stadium IIIA ikke-småcellet lungekræft, som er blevet fuldstændig fjernet under kirurgi.

Studieoversigt

Status

Afsluttet

Betingelser

Lungekræft

Intervention / Behandling

Detaljeret beskrivelse

MÅL:

Bestem den humorale og T-celle respons på adjuverende monoklonalt antistof 11D10 anti-idiotype vaccine og monoklonalt antistof 3H1 anti-idiotype vaccine med strålebehandling hos patienter med fuldstændig resekeret fase II eller IIIA ikke-småcellet lungecancer.
Bestem den kvalitative og kvantitative toksicitet og reversibilitet af toksicitet af dette regime hos disse patienter.
Bestem den progressionsfrie og samlede overlevelse for patienter, der behandles med dette regime.

OVERSIGT: Dette er en multicenterundersøgelse.

Patienterne modtager monoklonalt antistof 11D10 anti-idiotype vaccine og monoklonalt antistof 3H1 anti-idiotype vaccine intrakutant på separate steder en gang om ugen i 3 uger begyndende 2-7 uger (senest 49 dage) efter operationen og derefter subkutant én gang om måneden i 2 år uanset sygdomsprogression. Begyndende ikke mere end 1 uge efter den tredje postoperative vaccination, gennemgår alle patienter strålebehandling 5 dage om ugen i 5-6 uger. Patienter med ekstrakapsulære nodale metastaser eller T3-læsioner gennemgår også 6 yderligere strålebehandlingsboosts.

Patienterne følges efter 4-6 uger, hver 3. måned i 1 år, hver 4. måned i 1 år, hver 6. måned i 3 år og derefter årligt.

PROJEKTERET TILSLUTNING: I alt 54 patienter vil blive akkumuleret til denne undersøgelse.

Undersøgelsestype

Interventionel

Fase

Fase 2

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 4MI
    - 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, 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
  - Concord, California, Forenede Stater, 94524-4110
    - Mount Diablo Medical Center
  - Duarte, California, Forenede Stater, 91010-3000
    - City of Hope Comprehensive Cancer Center
  - Fremont, California, Forenede Stater, 45267-0502
    - Abgenix
  - Fresno, California, Forenede Stater, 93720
    - Saint Agnes Cancer Center
  - Fresno, California, Forenede Stater, 93729-5100
    - California 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, 90033-0804
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Los Angeles, California, Forenede Stater, 90025-1781
    - 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, 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
  - 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, 06511
    - Hospital of St. Raphael
- Delaware
  - Newark, Delaware, Forenede Stater, 19713
    - CCOP - Christiana Care Health Services
- Florida
  - 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
- 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
  - 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
    - Cancer Center at Lexington Clinic
  - 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
  - Salisbury, Maryland, Forenede Stater, 21801
    - Peninsula Regional Medical Center
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02115
    - 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)
- 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
  - 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, 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
- 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, 38103-2807
    - 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
  - 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, 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 Medical Center
  - Rochester, New York, Forenede Stater, 14642
    - James P. Wilmot Cancer Center
  - Rochester, New York, Forenede Stater, 14642
    - James P. Wilmot Cancer Center at the University of Rochester Medical 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
  - 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
  - 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 Program
- Pennsylvania
  - 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, 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
  - 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
  - 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
- 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, 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
  - 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

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 fase II eller IIIA ikke-småcellet lungecancer
- T1-3, N1-2, M0
- Ingen stadium IIIB (f.eks. kontralateral N3), stadium IV (M1) eller T3, N0, M0 sygdom
- N1-sygdom er kun berettiget, hvis der er involvering af hilar lymfeknuder
- Intet bronchoalveolært karcinom med lobar eller multilobar involvering
- Intet småcellet lungekarcinom, inklusive blandet histologi
Ikke mere end 7 uger siden tidligere operation (lobektomi, ærmeresektion, bilobektomi eller pneumonektomi)
- Negative kirurgiske marginer
- Ingen ufuldstændigt resekeret grov sygdom ELLER
- Ingen mikroskopisk positive bronchiale eller vaskulære marginer
Ingen kendt CNS-metastase

PATIENT KARAKTERISTIKA:

Alder:

18 og derover

Ydeevnestatus:

Zubrod 0-1

Forventede levealder:

Ikke specificeret

Hæmatopoietisk:

Absolut neutrofiltal mindst 2.000/mm^3
Blodpladetal mindst 100.000/mm^3

Hepatisk:

Ikke specificeret

Nyre:

Kreatinin ikke større end 1,5 mg/dL ELLER
Kreatininclearance større end 60 ml/min

Kardiovaskulær:

Intet superior vena cava syndrom

Lunge:

FEV_1 mindst 1,0 L

Gastrointestinale:

Ingen tidligere cøliaki, familiær polypose, Turcots syndrom, Gardners syndrom, Peutz-Jeghers syndrom eller arvelig non-polypose tyktarmskræft
Ingen tidligere colitis, inflammatorisk tarmsygdom eller pancreatitis inden for de seneste 10 år

Andet:

Ikke gravid
Negativ graviditetstest
Fertile patienter skal bruge effektiv prævention
Ingen kendt følsomhed over for gnaverproteiner
Ingen tidligere overfølsomhed eller kontraindikation til undersøgelsesbehandlinger (f.eks. monoklonalt antistof 11D10 anti-idiotype vaccine, monoklonalt antistof 3H1 anti-idiotype vaccine, aluminiumhydroxid eller murine proteiner) eller nogen hjælpestoffer
Ingen tidligere klinisk signifikante overfølsomhedsreaktioner (f.eks. angioødem, anafylaksi eller alvorlige dermatologiske manifestationer) eller astmatiske anfald, der kræver hospitalsindlæggelse
Ingen tidligere immun- eller immundefektlidelser (f.eks. HIV, sarkoidose, tuberkulose, leddegigt eller autoimmune lidelser)
Ingen tidligere anfaldssygdom, der kræver kontinuerlig medicinering
Ingen aktiv infektion
Ingen anden tidligere eller samtidig malignitet inden for de seneste 3 år undtagen kirurgisk behandlet carcinom in situ i livmoderhalsen eller pladecelle- eller basalcellehudkræft
Ingen medicinsk kontraindikation til kirurgi, strålebehandling eller immunterapi
Intet tidligere stof- eller alkoholmisbrug (undtagen nikotin) inden for de seneste 12 måneder
Ingen tidligere psykiatrisk eller vanedannende lidelse, der ville udelukke undersøgelsesoverholdelse

FORUDSÆTNING SAMTYDLIG TERAPI:

Biologisk terapi:

Ingen tidligere murine antistoffer (f.eks. OncoScint-scanning)
Ingen tidligere monoklonalt antistof 11D10 anti-idiotype vaccine, monoklonalt antistof 3H1 anti-idiotype vaccine eller anden carcinoembryonisk antigen-afledt undersøgelsesterapi
Mindst 3 år siden anden tidligere immunterapi
Mindst 30 dage siden forudgående immunisering (f.eks. influenza)
Ingen immunmodulerende terapi (f.eks. guld, auranofin, hydroxychloroquin, sulfasalazin, penicillamin, levamisol, dapson, azathioprin, intravenøs immunglobulin, leukotrienantagonister, cromoglycat, ketotifen, nedocromil, psoralin-ultra eller 30 før plasmadosis før første dosis) af undersøgelseslægemidlet eller 5 halveringstider af midlets virkning, alt efter hvad der er længst

Kemoterapi:

Mindst 3 år siden tidligere kemoterapi undtagen topikal terapi
Ingen samtidig methotrexat eller cyclophosphamid

Endokrin terapi:

Mindst 45 dage siden tidligere kortikosteroider
Ingen samtidige systemiske kortikosteroider

Strålebehandling:

Ingen forudgående thoraxstrålebehandling

Kirurgi:

Se Sygdomskarakteristika

Andet:

Mindst 45 dage siden tidligere immunsuppressiva
Ingen forsøgsmidler inden for 30 før den første dosis af forsøgslægemidlet eller 5 halveringstider af midlets virkning, alt efter hvad der er længst
Ingen samtidig amifostin
Ingen samtidig cyclosporin
Ingen andre samtidige immunsuppressiva
Ingen samtidige kroniske systemiske antihistaminer

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

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: Benjamin Movsas, MD, Fox Chase Cancer Center

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 2001

Primær færdiggørelse (Faktiske)

1. december 2004

Datoer for studieregistrering

Først indsendt

6. november 2000

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. august 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. august 2013

Sidst verificeret

1. august 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

RTOG-9909
CDR0000068293

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 .