- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00238264
Radiation Therapy in Treating Young Patients With Gliomas
A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas
RATIONALE: Specialized radiation therapy that delivers radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating young patients with gliomas.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
Primary
- Determine the marginal-failure rate in young patients with low-grade gliomas treated with reduced-field conformal radiotherapy.
Secondary
- Determine the progression-free survival, event-free survival, and overall survival rates of young patients treated with this regimen.
- Determine quality of life of patients treated with this regimen.
- Correlate MIB-1 labeling index with progression-free survival and overall survival of these patients.
OUTLINE: This is a multicenter study.
Patients undergo reduced-field conformal radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline or 6 weeks after completion of study treatment and then at 2 and 5 years (closed as of 10/27/2010).
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
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Queensland
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Brisbane, Queensland, Australien, 4029
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australien, 6001
- Princess Margaret Hospital for Children
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Quebec, Canada, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- Children's & Women's Hospital of British Columbia
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3J 3G9
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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London, Ontario, Canada, N6A 5W9
- Children's Hospital of Western Ontario
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canada, H3T 1C5
- Hôpital Sainte Justine
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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-
-
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- UAB Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, Forenede Stater, 85016-7710
- Phoenix Children's Hospital
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Forenede Stater, 90027
- Southern California Permanente Medical Group
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Loma Linda, California, Forenede Stater, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Forenede Stater, 90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
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Los Angeles, California, Forenede Stater, 90027
- Childrens Hospital Los Angeles
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Los Angeles, California, Forenede Stater, 90048-1865
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
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Madera, California, Forenede Stater, 93638-8762
- Children's Hospital Central California
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Oakland, California, Forenede Stater, 94609
- Children's Hospital and Research Center Oakland
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Orange, California, Forenede Stater, 92868
- Children's Hospital of Orange County
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Cancer Center
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Sacramento, California, Forenede Stater, 95825
- Kaiser Permanente Medical Center - Oakland
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San Diego, California, Forenede Stater, 92123-4282
- Rady Children's Hospital - San Diego
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San Francisco, California, Forenede Stater, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Children's Hospital Center for Cancer and Blood Disorders
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Denver, Colorado, Forenede Stater, 80218
- Presbyterian - St. Luke's Medical Center
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Connecticut
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Hartford, Connecticut, Forenede Stater, 06106
- Connecticut Children's Medical Center
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Delaware
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Wilmington, Delaware, Forenede Stater, 19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
-
Washington, District of Columbia, Forenede Stater, 20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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Washington, District of Columbia, Forenede Stater, 20307-5001
- Walter Reed Army Medical Center
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Florida
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Fort Myers, Florida, Forenede Stater, 33901
- Lee Cancer Care of Lee Memorial Health System
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Hollywood, Florida, Forenede Stater, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Jacksonville, Florida, Forenede Stater, 32207
- Nemours Children's Clinic
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Miami, Florida, Forenede Stater, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, Forenede Stater, 33155
- Miami Children's Hospital
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Orlando, Florida, Forenede Stater, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Orlando, Florida, Forenede Stater, 32806
- Nemours Children's Clinic - Orlando
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Orlando, Florida, Forenede Stater, 32806
- M.D. Anderson Cancer Center at Orlando
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Pensacola, Florida, Forenede Stater, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Saint Petersburg, Florida, Forenede Stater, 33701
- All Children's Hospital
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Tampa, Florida, Forenede Stater, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, Forenede Stater, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
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Augusta, Georgia, Forenede Stater, 30912-3730
- MBCCOP - Medical College of Georgia Cancer Center
-
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- Cancer Research Center of Hawaii
-
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Idaho
-
Boise, Idaho, Forenede Stater, 83712-6297
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
-
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Illinois
-
Chicago, Illinois, Forenede Stater, 60637-1470
- University of Chicago Cancer Research Center
-
Chicago, Illinois, Forenede Stater, 60612-7243
- University of Illinois Cancer Center
-
Oak Lawn, Illinois, Forenede Stater, 60453
- Keyser Family Cancer Center at Advocate Hope Children's Hospital
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Park Ridge, Illinois, Forenede Stater, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Peoria, Illinois, Forenede Stater, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, Forenede Stater, 62794-9677
- Simmons Cooper Cancer Institute
-
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Forenede Stater, 46260
- St. Vincent Indianapolis Hospital
-
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
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Louisville, Kentucky, Forenede Stater, 40232
- Kosair Children's Hospital
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Louisiana
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Alexandria, Louisiana, Forenede Stater, 71315-3198
- Tulane Cancer Center Office of Clinical Research
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Maryland
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Baltimore, Maryland, Forenede Stater, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Michigan
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Detroit, Michigan, Forenede Stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Grand Rapids, Michigan, Forenede Stater, 49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods, Michigan, Forenede Stater, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Kalamazoo, Michigan, Forenede Stater, 49007-5381
- CCOP - Kalamazoo
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Lansing, Michigan, Forenede Stater, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Forenede Stater, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Kansas City, Missouri, Forenede Stater, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Forenede Stater, 63104
- Cardinal Glennon Children's Hospital
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Saint Louis, Missouri, Forenede Stater, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89109-2306
- CCOP - Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- Hackensack University Medical Center Cancer Center
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Morristown, New Jersey, Forenede Stater, 07962
- Overlook Hospital
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New Brunswick, New Jersey, Forenede Stater, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Paterson, New Jersey, Forenede Stater, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87131-5636
- University of New Mexico Cancer Center
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New York
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Bronx, New York, Forenede Stater, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Brooklyn, New York, Forenede Stater, 11219
- Maimonides Cancer Center at Maimonides Medical Center
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Buffalo, New York, Forenede Stater, 14263-0001
- Roswell Park Cancer Institute
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Mineola, New York, Forenede Stater, 11501
- Winthrop University Hospital
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New York, New York, Forenede Stater, 10065
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Forenede Stater, 10016
- NYU Cancer Institute at New York University Medical Center
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New York, New York, Forenede Stater, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Rochester, New York, Forenede Stater, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Stony Brook, New York, Forenede Stater, 11794-9446
- Stony Brook University Cancer Center
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Syracuse, New York, Forenede Stater, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Forenede Stater, 10595
- New York Medical College
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Charlotte, North Carolina, Forenede Stater, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Durham, North Carolina, Forenede Stater, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Forenede Stater, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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Ohio
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Akron, Ohio, Forenede Stater, 44308-1062
- Akron Children's Hospital
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Cincinnati, Ohio, Forenede Stater, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Forenede Stater, 44106-5000
- Rainbow Babies and Children's Hospital
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Columbus, Ohio, Forenede Stater, 43205-2696
- Nationwide Children's Hospital
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Dayton, Ohio, Forenede Stater, 45404-1815
- Dayton Children's - Dayton
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Toledo, Ohio, Forenede Stater, 43614
- Medical University of Ohio Cancer Center
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Youngstown, Ohio, Forenede Stater, 44501
- Tod Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Oklahoma University Cancer Institute
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Oregon
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Portland, Oregon, Forenede Stater, 97239-3098
- Knight Cancer Institute at Oregon Health and Science University
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Portland, Oregon, Forenede Stater, 97227
- Legacy Emanuel Hospital and Health Center and Children's Hospital
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Pennsylvania
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Hershey, Pennsylvania, Forenede Stater, 17033-0850
- Penn State Children's Hospital
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Philadelphia, Pennsylvania, Forenede Stater, 19134-1095
- St. Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Children's Hospital of Pittsburgh of UPMC
-
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Columbia, South Carolina, Forenede Stater, 29203
- Palmetto Health South Carolina Cancer Center
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Greenville, South Carolina, Forenede Stater, 29605
- Greenville Hospital Cancer Center
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Knoxville, Tennessee, Forenede Stater, 37901
- East Tennessee Children's Hospital
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Memphis, Tennessee, Forenede Stater, 38105
- St. Jude Children's Research Hospital
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Texas
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Amarillo, Texas, Forenede Stater, 79106
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
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Corpus Christi, Texas, Forenede Stater, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Forenede Stater, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, Forenede Stater, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, Forenede Stater, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Lubbock, Texas, Forenede Stater, 79410
- Covenant Children's Hospital
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San Antonio, Texas, Forenede Stater, 78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio, Texas, Forenede Stater, 78207
- University of Texas Health Science Center at San Antonio
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Temple, Texas, Forenede Stater, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Forenede Stater, 84113-1100
- Primary Children's Medical Center
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Vermont
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Burlington, Vermont, Forenede Stater, 05401
- Fletcher Allen Health Care - University Health Center Campus
-
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Virginia
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Falls Church, Virginia, Forenede Stater, 22042-3300
- INOVA Fairfax Hospital
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Norfolk, Virginia, Forenede Stater, 23507-1971
- Children's Hospital of The King's Daughters
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Roanoke, Virginia, Forenede Stater, 24014
- Carilion Medical Center for Children at Roanoke Community Hospital
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Washington
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Seattle, Washington, Forenede Stater, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Spokane, Washington, Forenede Stater, 99220-2555
- Providence Cancer Center at Sacred Heart Medical Center
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West Virginia
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Charleston, West Virginia, Forenede Stater, 25302
- West Virginia University Health Sciences Center - Charleston
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Huntington, West Virginia, Forenede Stater, 25701
- Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
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Morgantown, West Virginia, Forenede Stater, 26506
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
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Wisconsin
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Green Bay, Wisconsin, Forenede Stater, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Madison, Wisconsin, Forenede Stater, 53792-6164
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Midwest Children's Cancer Center at Children's Hospital of Wisconsin
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-
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Auckland, New Zealand, 1
- Starship Children's Health
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Christchurch, New Zealand, 8140
- Christchurch Hospital
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Wellington, New Zealand, 6002
- Wellington Children's Hospital
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-
-
-
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Santurce, Puerto Rico, 00912
- San Jorge Children's Hospital
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-
-
-
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Geneva, Schweiz, 1205
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Schweiz, 1011
- Swiss Pediatric Oncology Group Lausanne
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically confirmed* low-grade glioma, including any of the following:
- Juvenile pilocytic astrocytoma (JPA) or pleomorphic JPA
Diffuse astrocytoma, including any of the following subtypes:
- Fibrillary astrocytoma
- Gemistocytic astrocytoma
- Subependymal giant cell astrocytoma
- Pleomorphic xanthoastrocytoma
- Low-grade oligoastrocytoma
- Low-grade oligodendroglioma
- Low-grade glioma not otherwise specified NOTE: *Patients with chiasmatic lesions who have contiguous extension of tumor into other regions of the visual pathway by CT scan or MRI are eligible without histopathologic confirmation; repeat biopsy required for patients with recurrent tumors that enhance but whose initial tumor did not
- Measurable disease by radiography
Meets any of the following criteria:
Progressive nonresectable disease
- Any location in the brain
- Patients with a less than gross total resection are eligible provided they are symptomatic from their tumor OR the risk from neurologic impairment with progression is high enough to warrant immediate treatment
- Has undergone biopsy only
Must have received ≥ 1 course of prior chemotherapy (for patients < 10 years of age)
- Prior chemotherapy optional (for patients ≥ 10 years of age)
- No type-1 neurofibromatosis
- No evidence of leptomeningeal dissemination
PATIENT CHARACTERISTICS:
Age
- 3 to 20
Performance status
- ECOG 0-2 OR
- Karnofsky 50-100% (for patients > 16 years of age) OR
- Lansky 50-100% (for patients ≤ 16 years of age)
Life expectancy
- At least 1 year
Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 100,000/mm^3 (transfusion independent)
- Hemoglobin ≥ 10.0 g/dL (transfusions allowed)
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- Not in status epilepticus, coma, or requiring assisted ventilation prior to study entry
- Patients with a seizure disorder are eligible provided they are on anticonvulsants AND disease is well controlled
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- Recovered from prior chemotherapy
- No concurrent chemotherapy
Endocrine therapy
- Concurrent dexamethasone allowed provided patient has been on a stable dose for ≥ 2 weeks prior to study entry
- Concurrent dexamethasone allowed for symptoms of increased intracranial pressure
Radiotherapy
- No prior radiotherapy
Surgery
- See Disease Characteristics
Other
- No other concurrent anticancer therapy
Studieplan
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: Treatment (radiotherapy)
Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
|
Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Marginal-failure Rate
Tidsramme: Up to 5 years
|
Patients who do not recur as well as those with either central or distant recurrence would be treatment successes for this endpoint.
Monitoring will be based on a Bayesian rule, with binomial likelihood and a Beta on the parameter p, the proportion of failures that are marginal failures.
|
Up to 5 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free Survival Probability
Tidsramme: 3 years
|
To estimate the progression-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.
|
3 years
|
|
Event-free Survival Probability
Tidsramme: 3 years
|
To estimate the event-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation
|
3 years
|
|
Overall Survival Probability
Tidsramme: 3 years
|
To estimate the overall survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.
|
3 years
|
|
Quality of Life (QOL)
Tidsramme: Up to 5 years
|
QOL accessed using the Behavior Assessment System for Children (BASC), the Adaptive Behavior Assessment System (ABAS), the Behavior Rating Inventory of Executive Function (BRIEF), and the Symptom Checklist-90-R (SCL-90-R).
|
Up to 5 years
|
|
MIB-1 Labeling Index Using Immunohistochemical Techniques With the MIB-1 Antibody According to Established Methods
Tidsramme: At baseline
|
The MIB-1 labeling Index will be calculated as the percentage of tumor nuclei that are immunoreactive.
|
At baseline
|
|
Correlation MIB-1 Labeling Index With PFS
Tidsramme: Up to 10 years
|
The primary methods of analysis will be via stratified Cox regression
|
Up to 10 years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Edward G. Shaw, MD, Wake Forest University Health Sciences
- Studiestol: Joel M. Cherlow, MD, Todd Cancer Institute at Long Beach Memorial Medical Center
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- ubehandlet cerebellar astrocytom i barndommen
- barndoms oligodendrogliom
- tilbagevendende cerebellar astrocytom i barndommen
- tilbagevendende cerebralt astrocytom i barndommen
- tilbagevendende barndomssynsvej og hypothalamus gliom
- barndom lavgradigt cerebralt astrocytom
- ubehandlet barndomssynsvej og hypothalamus gliom
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ACNS0221
- COG-ACNS0221 (Anden identifikator: Clinical Trials.gov)
- CIRB-05016 (Anden identifikator: Pediatric CIRB)
- CDR0000445095 (Anden identifikator: Clinical Trials.gov)
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