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Kemoterapi og strålebehandling efter kirurgi til behandling af børn med nyligt diagnosticeret astrocytom, glioblastoma multiforme, gliosarcoma eller diffust indre pontinsk gliom

19. februar 2014 opdateret af: Children's Oncology Group

Et fase II-studie af temozolomid til behandling af børn med højgradig gliom

RATIONALE: Lægemidler, der bruges i kemoterapi, bruger forskellige måder til at forhindre tumorceller i at dele sig, så de holder op med at vokse eller dør. Strålebehandling bruger højenergi røntgenstråler til at beskadige tumorceller. At give kemoterapi sammen med strålebehandling kan dræbe flere tumorceller.

FORMÅL: Dette fase II-forsøg undersøger, hvor godt det virker at give kemoterapi sammen med strålebehandling efter operation efterfulgt af kemoterapi alene hos børn med nydiagnosticeret astrocytom, glioblastoma multiforme, gliosarcoma eller diffust intrinsic pontine gliom.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

MÅL:

  • Sammenlign den hændelsesfrie overlevelse af patienter med nyligt diagnosticeret anaplastisk astrocytom, glioblastoma multiforme, gliosarcoma eller diffust intrinsic pontine gliom (DIPG) behandlet med adjuverende temozolomid indgivet samtidig med postoperativ strålebehandling og derefter alene som vedligeholdelsesbehandling i tidligere petrodiagnostik vs. Onkologisk gruppe og børnekræftgruppe undersøgelser.
  • Bestem toksiciteten af ​​denne kur hos disse patienter.
  • Bestem effektiviteten af ​​dette regime hos patienter med DIPG.
  • Bestem toksiciteten af ​​dette regime hos patienter med DIPG.

OVERSIGT: Dette er en multicenterundersøgelse.

  • Adjuverende kemoradioterapi: Begyndende inden for 6 uger efter kirurgisk resektion eller diagnose*, gennemgår patienter uden grov restsygdom kraniebestråling 5 dage om ugen i 6 uger. Begyndende inden for 6 uger efter kirurgisk resektion gennemgår patienter med grov resterende sygdom strålebehandling som ovenfor efterfulgt af boost-strålebehandling i 1 uge. Alle patienter får oralt temozolomid én gang dagligt begyndende inden for 5 dage efter påbegyndelse af strålebehandling og fortsætter i i alt 6 uger i fravær af sygdomsprogression eller uacceptabel toksicitet.
  • Adjuverende vedligeholdelsesbehandling: Begyndende 4 uger efter afslutning af adjuverende kemoradioterapi får patienterne oral temozolomid på dag 1-5. Behandlingen gentages hver 28. dag i i alt 10 kure i fravær af sygdomsprogression eller uacceptabel toksicitet.

BEMÆRK: *Kun for patienter med diffust intrinsisk pontingliom

Patienterne følges hver 3.-6. måned i 4 år og derefter årligt derefter.

PROJEKTERET TILSLUTNING: I alt 50-60 patienter vil blive akkumuleret til denne undersøgelse inden for 12-14 måneder.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

170

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Australien
    • New South Wales
      • Randwick, New South Wales, Australien, 2031
        • Sydney Children's Hospital
      • Westmead, New South Wales, Australien, 2145
        • Children's Hospital at Westmead
    • Queensland
      • Brisbane, Queensland, Australien, 4029
        • Royal Children's Hospital
    • South Australia
      • North Adelaide, South Australia, Australien, 5006
        • Women's and Children's Hospital
    • Victoria
      • Parkville, Victoria, Australien, 3052
        • Royal Children's Hospital
    • Western Australia
      • Perth, Western Australia, Australien, 6001
        • Princess Margaret Hospital for Children
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2T 5C7
        • Alberta Children's Hospital
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute at University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • British Columbia Children's Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Janeway Children's Health and Rehabilitation Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3J 3G9
        • IWK Health Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4J9
        • McMaster Children's Hospital at Hamilton Health Sciences
      • London, Ontario, Canada, N6C 2V5
        • Children's Hospital of Western Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Hopital Sainte Justine
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal Children's Hospital at McGill University Health Center
      • Sainte Foy, Quebec, Canada, GIV 4G2
        • Centre de Recherche du Centre Hospitalier de l'Universite Laval
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre at Pasqua Hospital
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • Comprehensive Cancer Center at University of Alabama at Birmingham
      • Mobile, Alabama, Forenede Stater, 36604
        • University of South Alabama Cancer Research Institute
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85016
        • Phoenix Children's Hospital
      • Tucson, Arizona, Forenede Stater, 85724
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Downey, California, Forenede Stater, 90242
        • Southern California Permanente Medical Group
      • Duarte, California, Forenede Stater, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • La Jolla, California, Forenede Stater, 92093-0658
        • Rebecca and John Moores UCSD Cancer Center
      • Loma Linda, California, Forenede Stater, 92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
      • Long Beach, California, Forenede Stater, 90801-1428
        • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
      • Los Angeles, California, Forenede Stater, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
      • Los Angeles, California, Forenede Stater, 90027-0700
        • Children's Hospital Los Angeles
      • Los Angeles, California, Forenede Stater, 90048
        • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
      • Madera, California, Forenede Stater, 93638-8762
        • Children's Hospital Central California
      • Oakland, California, Forenede Stater, 94609-1809
        • Children's Hospital and Research Center at Oakland
      • Orange, California, Forenede Stater, 92868
        • Children's Hospital of Orange County
      • Orange, California, Forenede Stater, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
      • Palo Alto, California, Forenede Stater, 94304
        • Lucile Packard Children's Hospital at Stanford University Medical Center
      • Sacramento, California, Forenede Stater, 95816
        • Sutter Cancer center
      • Sacramento, California, Forenede Stater, 95817
        • University of California Davis Cancer Center
      • Sacramento, California, Forenede Stater, 95825
        • Kaiser Permanente Medical Center - Sacramento
      • San Diego, California, Forenede Stater, 92120
        • Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
      • San Diego, California, Forenede Stater, 92123-4282
        • Children's Hospital and Health Center - San Diego
      • San Francisco, California, Forenede Stater, 94143
        • UCSF Comprehensive Cancer Center
      • Santa Barbara, California, Forenede Stater, 93102
        • Santa Barbara Cottage Hospital
      • Santa Clara, California, Forenede Stater, 95051-5386
        • Kaiser Permanente Medical Center - Santa Clara Kiely Campus
      • Travis Air Force Base, California, Forenede Stater, 94535
        • General Robert Huyser Cancer Center at David Grant Medical Center
    • Colorado
      • Denver, Colorado, Forenede Stater, 80218
        • Presbyterian - St. Luke's Medical Center
      • Denver, Colorado, Forenede Stater, 80218
        • Children's Hospital Cancer Center
    • Connecticut
      • Farmington, Connecticut, Forenede Stater, 06360-7106
        • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
      • New Haven, Connecticut, Forenede Stater, 06520-8064
        • Yale Comprehensive Cancer Center
    • Delaware
      • Wilmington, Delaware, Forenede Stater, 19899
        • Alfred I. DuPont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20007
        • Lombardi Cancer Center at Georgetown University Medical Center
      • Washington, District of Columbia, Forenede Stater, 20010-2970
        • Children's National Medical Center
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • Broward General Medical Center
      • Fort Myers, Florida, Forenede Stater, 33908
        • Children's Hospital of Southwest Florida
      • Gainesville, Florida, Forenede Stater, 32610-0296
        • University of Florida Shands Cancer Center
      • Hollywood, Florida, Forenede Stater, 33021
        • Joe DiMaggio Children's Hospital at Memorial
      • Jacksonville, Florida, Forenede Stater, 32207
        • Nemours Children's Clinic
      • Miami, Florida, Forenede Stater, 33155
        • Miami Children's Hospital
      • Miami, Florida, Forenede Stater, 33136
        • Jackson Memorial Hospital
      • Miami, Florida, Forenede Stater, 33176-2197
        • Baptist-South Miami Regional Cancer Program
      • Orlando, Florida, Forenede Stater, 32804
        • Florida Hospital Cancer Institute
      • Orlando, Florida, Forenede Stater, 32806
        • Nemours Children's Clinic-Orlando
      • Pensacola, Florida, Forenede Stater, 32504
        • Sacred Heart Children's Hospital
      • St. Petersburg, Florida, Forenede Stater, 33701
        • All Children's Hospital
      • Tampa, Florida, Forenede Stater, 33677-4227
        • St. Joseph's Children's Hospital of Tampa
      • West Palm Beach, Florida, Forenede Stater, 33407
        • Kaplan Cancer Center at St. Mary's Medical Center
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
      • Augusta, Georgia, Forenede Stater, 30912-4000
        • MBCCOP-Medical College of Georgia Cancer Center
      • Macon, Georgia, Forenede Stater, 31201
        • Medical Center of Central Georgia
      • Savannah, Georgia, Forenede Stater, 31405
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96859-5000
        • Tripler Army Medical Center
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Cancer Research Center of Hawaii
    • Idaho
      • Boise, Idaho, Forenede Stater, 83712
        • St. Luke's Mountain States Tumor Institute - Boise
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center
      • Chicago, Illinois, Forenede Stater, 60614
        • Children's Memorial Hospital - Chicago
      • Chicago, Illinois, Forenede Stater, 60601
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Forenede Stater, 60612
        • University Of Illinois Medical Center
      • Oak Lawn, Illinois, Forenede Stater, 60453
        • Advocate Hope Children's Hospital
      • Park Ridge, Illinois, Forenede Stater, 60068-1174
        • Lutheran General Cancer Care Center
      • Peoria, Illinois, Forenede Stater, 61637
        • Saint Jude Midwest Affiliate
      • Springfield, Illinois, Forenede Stater, 62794-9658
        • Southern Illinois University School of Medicine
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202-5225
        • Riley Children Cancer Center at Riley Hospital for Children
      • Indianapolis, Indiana, Forenede Stater, 46260
        • St. Vincent Hospitals and Health Care Centers
    • Iowa
      • Des Moines, Iowa, Forenede Stater, 50309
        • Blank Children's Hospital
      • Iowa City, Iowa, Forenede Stater, 52242-1009
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67214
        • Wesley Medical Center
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536-0284
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
      • Louisville, Kentucky, Forenede Stater, 40202-3830
        • Kosair Children's Hospital
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70118
        • Children's Hospital of New Orleans
      • New Orleans, Louisiana, Forenede Stater, 70112
        • MBCCOP - LSU Health Sciences Center
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Cancer Institute at Ochsner Clinic Foundation
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane Cancer Center at Tulane University Hospital and Clinic
    • Maine
      • Bangor, Maine, Forenede Stater, 04401
        • Pediatric Specialty Clinic at Eastern Maine Medical Center
      • Scarborough, Maine, Forenede Stater, 04074-9308
        • Maine Children's Cancer Program
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21215
        • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
      • Baltimore, Maryland, Forenede Stater, 21201-1595
        • Greenebaum Cancer Center at University of Maryland Medical Center
      • Baltimore, Maryland, Forenede Stater, 21231-7223
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Silver Spring, Maryland, Forenede Stater, 20910
        • Walter Reed Army Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Boston, Massachusetts, Forenede Stater, 02111
        • Floating Hospital for Children
      • Springfield, Massachusetts, Forenede Stater, 01107
        • Baystate Regional Cancer Program at D'Amour Center for Cancer Care
      • Worcester, Massachusetts, Forenede Stater, 01655
        • UMASS Memorial Cancer Center - University Campus
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109-0914
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, Forenede Stater, 48201
        • Children's Hospital of Michigan
      • Detroit, Michigan, Forenede Stater, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Flint, Michigan, Forenede Stater, 48503
        • Hurley Medical Center
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • DeVos Children's Hospital
      • Kalamazoo, Michigan, Forenede Stater, 49007-5364
        • Bronson Methodist Hospital
      • Lansing, Michigan, Forenede Stater, 48910
        • Breslin Cancer Center at Ingham Regional Medical Center
      • Royal Oak, Michigan, Forenede Stater, 48073-6769
        • William Beaumont Hospital - Royal Oak Campus
    • Minnesota
      • Duluth, Minnesota, Forenede Stater, 55805
        • St. Mary's - Duluth Clinic Cancer Center
      • Minneapolis, Minnesota, Forenede Stater, 55404
        • Children's Hospitals and Clinics - Minneapolis/St. Paul
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic Cancer Center
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216-4505
        • University of Mississippi Medical Center
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65203
        • University of Missouri - Columbia
      • Kansas City, Missouri, Forenede Stater, 64108
        • Children's Mercy Hospital
      • Saint Louis, Missouri, Forenede Stater, 63110
        • St. Louis Children's Hospital
      • Saint Louis, Missouri, Forenede Stater, 63104
        • Cardinal Glennon Children's Hospital
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68114
        • Children's Hospital of Omaha
      • Omaha, Nebraska, Forenede Stater, 68198-2168
        • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89109
        • Nevada Cancer Research Foundation
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack University Medical Center
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
      • Newark, New Jersey, Forenede Stater, 07112-2094
        • Newark Beth Israel Medical Center
      • Paterson, New Jersey, Forenede Stater, 07503
        • St. Joseph's Hospital and Medical Center
      • Summit, New Jersey, Forenede Stater, 07901
        • Valerie Fund Children's Center at Atlantic Health
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131
        • University of New Mexico Cancer Research and Treatment Center
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Children's Hospital at Albany Medical Center
      • Bronx, New York, Forenede Stater, 10461
        • Albert Einstein Cancer Center at Albert Einstein College of Medicine
      • Brooklyn, New York, Forenede Stater, 11203
        • SUNY downstate Medical Center
      • Brooklyn, New York, Forenede Stater, 11212
        • Brookdale University Hospital and Medical Center
      • Brooklyn, New York, Forenede Stater, 11201-5493
        • Brooklyn Hospital Center
      • Brooklyn, New York, Forenede Stater, 11219
        • Comprehensive Cancer Center at Maimonides Medical Center
      • New Hyde Park, New York, Forenede Stater, 11040
        • Schneider Children's Hospital
      • New York, New York, Forenede Stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Forenede Stater, 10021
        • New York Weill Cornell Cancer Center at Cornell University
      • New York, New York, Forenede Stater, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai Medical Center
      • Rochester, New York, Forenede Stater, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Stony Brook, New York, Forenede Stater, 11794-8174
        • Long Island Cancer Center at Stony Brook University Hospital
      • Syracuse, New York, Forenede Stater, 13210
        • SUNY Upstate Medical University Hospital
      • Valhalla, New York, Forenede Stater, 10595
        • New York Medical College
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28801
        • Mission Hospitals - Memorial Campus
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Charlotte, North Carolina, Forenede Stater, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Charlotte, North Carolina, Forenede Stater, 28233
        • Presbyterian Cancer Center at Presbyterian Hospital
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Comprehensive Cancer Center
      • Greenville, North Carolina, Forenede Stater, 27858-4354
        • Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
      • Winston-Salem, North Carolina, Forenede Stater, 27157-1081
        • Comprehensive Cancer Center at Wake Forest University
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58103-4940
        • Dakota Cancer Institute at Innovis Health - Dakota Clinic
    • Ohio
      • Akron, Ohio, Forenede Stater, 44308-1062
        • Children's Hospital Medical Center of Akron
      • Cincinnati, Ohio, Forenede Stater, 45229-3039
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, Forenede Stater, 44106-5065
        • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
      • Columbus, Ohio, Forenede Stater, 43205-2696
        • Columbus Children's Hospital
      • Dayton, Ohio, Forenede Stater, 45404
        • Children's Medical Center - Dayton
      • Toledo, Ohio, Forenede Stater, 43601
        • Toledo Children's Hospital
      • Toledo, Ohio, Forenede Stater, 43608
        • St. Vincent Mercy Medical Center
      • Youngstown, Ohio, Forenede Stater, 44501
        • Tod Children's Hospital - Forum Health
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Children's Hospital at Oklahoma University Medical Center
      • Tulsa, Oklahoma, Forenede Stater, 74136
        • Natalie Warren Bryant Cancer Center at St. Francis Hospital
    • Oregon
      • Portland, Oregon, Forenede Stater, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, Forenede Stater, 97227
        • Legacy Emanuel Hospital and Health Center & Children's Hospital
      • Portland, Oregon, Forenede Stater, 97239-3098
        • Doernbecher Children's Hospital at Oregon Health & Science University
    • Pennsylvania
      • Danville, Pennsylvania, Forenede Stater, 17822-1320
        • Geisinger Medical Center
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Penn State Children's Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, Forenede Stater, 19134-1095
        • St. Christopher's Hospital for Children
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Children's Hospital of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425-0721
        • Hollings Cancer Center at Medical University of South Carolina
      • Columbia, South Carolina, Forenede Stater, 29203
        • Palmetto Health South Carolina Cancer Center
      • Greenville, South Carolina, Forenede Stater, 29605
        • Children's Hospital of Greenville Hospital System
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57117-5039
        • Sioux Valley Hospital and University of South Dakota Medical Center
      • Sioux Falls, South Dakota, Forenede Stater, 57105-1080
        • Avera Cancer Institute
    • Tennessee
      • Johnson City, Tennessee, Forenede Stater, 37614-0622
        • East Tennessee State University Cancer Center at Johnson City Medical Center
      • Knoxville, Tennessee, Forenede Stater, 37901
        • East Tennessee Children's Hospital
      • Memphis, Tennessee, Forenede Stater, 38105
        • St. Jude Children's Research Hospital
      • Nashville, Tennessee, Forenede Stater, 37232-6310
        • Vanderbilt Children's Hospital
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • Texas Tech University Health Sciences Center School of Medicine
      • Austin, Texas, Forenede Stater, 78701
        • Children's Hospital of Austin
      • Dallas, Texas, Forenede Stater, 75230
        • Medical City Dallas Hospital
      • Dallas, Texas, Forenede Stater, 75390-9063
        • Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas
      • Fort Worth, Texas, Forenede Stater, 76104
        • Cook Children's Medical Center - Fort Worth
      • Galveston, Texas, Forenede Stater, 77555-0209
        • University of Texas Medical Branch
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine
      • Houston, Texas, Forenede Stater, 77030-4009
        • M.D. Anderson Cancer Center at University of Texas
      • Lackland Air Force Base, Texas, Forenede Stater, 78236
        • San Antonio Military Pediatric Cancer and Blood Disorders Center
      • Lubbock, Texas, Forenede Stater, 79410
        • Covenant Children's Hospital
      • San Antonio, Texas, Forenede Stater, 78207
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, Forenede Stater, 78229-3900
        • MBCCOP - South Texas Pediatrics
      • San Antonio, Texas, Forenede Stater, 78229-3902
        • Methodist Cancer Center at Methodist Specialty and Transplant Hospital
      • Temple, Texas, Forenede Stater, 76508
        • CCOP - Scott and White Hospital
      • Temple, Texas, Forenede Stater, 76508
        • Center for Cancer Prevention and Care at Scott and White Clinic
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Huntsman Cancer Institute at University of Utah
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401-3498
        • Vermont Cancer Center at University of Vermont
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • University of Virginia Cancer Center
      • Falls Church, Virginia, Forenede Stater, 22042-3300
        • Inova Fairfax Hospital
      • Norfolk, Virginia, Forenede Stater, 23507
        • Children's Hospital of The King's Daughters
      • Portsmouth, Virginia, Forenede Stater, 23708-5100
        • Naval Medical Center - Portsmouth
      • Richmond, Virginia, Forenede Stater, 23298-0121
        • Massey Cancer Center at Virginia Commonwealth University
      • Roanoke, Virginia, Forenede Stater, 24029
        • Carilion Medical Center for Children at Roanoke Community Hospital
    • Washington
      • Seattle, Washington, Forenede Stater, 98105
        • Children's Hospital and Regional Medical Center - Seattle
      • Seattle, Washington, Forenede Stater, 98109-1024
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, Forenede Stater, 98112
        • Group Health Central Hospital
      • Spokane, Washington, Forenede Stater, 99210-0248
        • Deaconess Medical Center
      • Tacoma, Washington, Forenede Stater, 98415-0299
        • Mary Bridge Children's Hospital and Health Center - Tacoma
      • Tacoma, Washington, Forenede Stater, 98431-0001
        • Madigan Army Medical Center
    • West Virginia
      • Charleston, West Virginia, Forenede Stater, 25302
        • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
      • Huntington, West Virginia, Forenede Stater, 25701
        • Cabell Huntington Hospital
      • Morgantown, West Virginia, Forenede Stater, 26506-9300
        • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
    • Wisconsin
      • Green Bay, Wisconsin, Forenede Stater, 54301
        • CCOP - St. Vincent Hospital Cancer Center, Green Bay
      • Green Bay, Wisconsin, Forenede Stater, 54301
        • Bellin Memorial Hospital
      • Green Bay, Wisconsin, Forenede Stater, 54307-9070
        • St. Vincent Hospital
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
      • Madison, Wisconsin, Forenede Stater, 53792-6164
        • University of Wisconsin Comprehensive Cancer Center
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • CCOP - Marshfield Clinic Research Foundation
      • Marshfield, Wisconsin, Forenede Stater, 54449-5772
        • Marshfield Clinic - Marshfield Center
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Midwest Children's Cancer Center
  • Holland
      • Groningen, Holland, 9700 RB
        • University Medical Center Groningen
  • New Zealand
      • Auckland, New Zealand
        • Starship Children's Health
  • Puerto Rico
      • San Juan, Puerto Rico, 00936-5067
        • Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
      • Santurce, Puerto Rico, 00912
        • San Jorge Children's Hospital
  • Schweiz
      • Bern, Schweiz, CH 3010
        • Swiss Pediatric Oncology Group Bern
      • Geneva, Schweiz, CH 1211
        • Swiss Pediatric Oncology Group Geneva
      • Lausanne, Schweiz, CH 1011
        • Swiss Pediatric Oncology Group Lausanne

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

3 år til 21 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

SYGDOMS KARAKTERISTIKA:

  • Histologisk bekræftet nyligt diagnosticeret CNS-tumor af følgende typer:

    • Højgradigt gliom (HGG) af en af ​​følgende histologier:

      • Anaplastisk astrocytom (grad III)
      • Glioblastoma multiforme (grad IV)
      • Gliosarkom
      • Primært malignt gliom i rygmarven

    • Diffus intrinsic pontine gliom (DIPG)

      • Diagnosticeret ved gadolinium-forstærket MR
      • Mindst 2/3 af tumoren placeret i pons OG tumor stammer tydeligt fra pons
      • Ingen diffus leptomeningeal sygdom

      • Ingen tumorer med træk, der ikke er typiske for diffust iboende hjernestammegliom, inklusive nogen af ​​følgende:

        • Dorsalt exofytisk hjernestammegliom
        • Cervico-medullær junction tumor
        • Fokalt lavgradigt gliom i mellemhjernen eller hjernestammen
      • Ingen diffus hjernestammeforstørrelse på grund af neurofibromatose
  • Intet primært malignt gliom i hjernestammen
  • Ingen M+ sygdom (CSF positiv for tumor eller metastatisk sygdom)
  • Skal påbegynde undersøgelse af strålebehandling inden for 6 uger efter kirurgisk resektion (for HGG-patienter) eller diagnose (for DIPG-patienter)

PATIENT KARAKTERISTIKA:

Alder:

  • 3 til 21

Ydeevnestatus:

  • Karnofsky 50-100 % ELLER
  • Lansky 50-100 %

Forventede levealder:

  • Mindst 2 måneder

Hæmatopoietisk:

  • Absolut neutrofiltal mindst 1.000/mm^3
  • Blodpladetal mindst 100.000/mm^3*
  • Hæmoglobin mindst 10,0 g/dL* BEMÆRK: *Transfusionsuafhængig

Hepatisk:

  • Bilirubin ikke større end 1,5 gange øvre normalgrænse (ULN)
  • SGOT eller SGPT mindre end 2,5 gange ULN

Nyre:

  • Kreatinin ikke større end 1,5 gange ULN

Andet:

  • Ingen anden samtidig malignitet
  • Samtidig anfaldslidelse er tilladt, hvis den er godt kontrolleret på antikonvulsiva
  • Ikke gravid eller ammende
  • Negativ graviditetstest
  • Fertile patienter skal anvende effektiv prævention under og i 2 måneder efter afsluttet undersøgelsesbehandling

FORUDSÆTNING SAMTYDLIG TERAPI:

Biologisk:

  • Ingen samtidig rutinemæssig cytokinstøtte

Kemoterapi:

  • Ikke specificeret

Endokrin terapi:

  • Ingen samtidige kortikosteroider bortset fra øget intrakranielt tryk hos patienter med CNS-tumorer

Strålebehandling:

  • Se Sygdomskarakteristika

Kirurgi:

  • Se Sygdomskarakteristika

Andet:

  • Ingen forudgående behandling for HGG eller DIPG

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Kemoradioterapi
Stråling: strålebehandling
Medicin: temozolomid
Procedure: adjuverende terapi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Forbedret resultat
Toksicitet vurderet af NCI CTCAE v. 2.0

Samarbejdspartnere og efterforskere

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

Sponsor

Children's Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Kenneth J. Cohen, MD, MBA, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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. december 2002

Primær færdiggørelse (Faktiske)

1. september 2007

Studieafslutning (Faktiske)

1. marts 2012

Datoer for studieregistrering

Først indsendt

4. januar 2002

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. februar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. februar 2014

Sidst verificeret

1. februar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ACNS0126
  • COG-ACNS0126 (Anden identifikator: Children's Oncology Group)
  • CDR0000069135 (Anden identifikator: Clinical Trials.gov)

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 .

Kliniske forsøg med Tumorer i hjernen og centralnervesystemet

Kliniske forsøg med strålebehandling

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Sponsorer og samarbejdspartnere

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CROs by country

CROs in Singapore

Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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