- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Queensland
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Brisbane, Queensland, Austrália, 4029
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Austrália, 6001
- Princess Margaret Hospital for Children
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Quebec, Canadá, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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British Columbia
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Vancouver, British Columbia, Canadá, V6H 3V4
- Children's & Women's Hospital of British Columbia
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Manitoba
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Winnipeg, Manitoba, Canadá, R3E 0V9
- CancerCare Manitoba
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3J 3G9
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canadá, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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London, Ontario, Canadá, N6A 5W9
- Children's Hospital of Western Ontario
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Ottawa, Ontario, Canadá, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Canadá, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canadá, H3T 1C5
- Hôpital Sainte Justine
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Saskatchewan
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Saskatoon, Saskatchewan, Canadá, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- UAB Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, Estados Unidos, 85016-7710
- Phoenix Children's Hospital
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Estados Unidos, 90027
- Southern California Permanente Medical Group
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Loma Linda, California, Estados Unidos, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Estados Unidos, 90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, Estados Unidos, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
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Los Angeles, California, Estados Unidos, 90027
- Childrens Hospital Los Angeles
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Los Angeles, California, Estados Unidos, 90048-1865
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
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Madera, California, Estados Unidos, 93638-8762
- Children's Hospital Central California
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Oakland, California, Estados Unidos, 94609
- Children's Hospital and Research Center Oakland
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Orange, California, Estados Unidos, 92868
- Children's Hospital of Orange County
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Sacramento, California, Estados Unidos, 95817
- University of California Davis Cancer Center
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Sacramento, California, Estados Unidos, 95825
- Kaiser Permanente Medical Center - Oakland
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San Diego, California, Estados Unidos, 92123-4282
- Rady Children's Hospital - San Diego
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San Francisco, California, Estados Unidos, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Children's Hospital Center for Cancer and Blood Disorders
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Denver, Colorado, Estados Unidos, 80218
- Presbyterian - St. Luke's Medical Center
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Connecticut
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Hartford, Connecticut, Estados Unidos, 06106
- Connecticut Children's Medical Center
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Delaware
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Wilmington, Delaware, Estados Unidos, 19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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Washington, District of Columbia, Estados Unidos, 20307-5001
- Walter Reed Army Medical Center
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Florida
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Fort Myers, Florida, Estados Unidos, 33901
- Lee Cancer Care of Lee Memorial Health System
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Hollywood, Florida, Estados Unidos, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Jacksonville, Florida, Estados Unidos, 32207
- Nemours Children's Clinic
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Miami, Florida, Estados Unidos, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, Estados Unidos, 33155
- Miami Children's Hospital
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Orlando, Florida, Estados Unidos, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Orlando, Florida, Estados Unidos, 32806
- Nemours Children's Clinic - Orlando
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Orlando, Florida, Estados Unidos, 32806
- M.D. Anderson Cancer Center at Orlando
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Pensacola, Florida, Estados Unidos, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Saint Petersburg, Florida, Estados Unidos, 33701
- All Children's Hospital
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Tampa, Florida, Estados Unidos, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, Estados Unidos, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
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Augusta, Georgia, Estados Unidos, 30912-3730
- MBCCOP - Medical College of Georgia Cancer Center
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96813
- Cancer Research Center of Hawaii
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Idaho
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Boise, Idaho, Estados Unidos, 83712-6297
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
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Illinois
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Chicago, Illinois, Estados Unidos, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Estados Unidos, 60612-7243
- University of Illinois Cancer Center
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Oak Lawn, Illinois, Estados Unidos, 60453
- Keyser Family Cancer Center at Advocate Hope Children's Hospital
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Park Ridge, Illinois, Estados Unidos, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Peoria, Illinois, Estados Unidos, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, Estados Unidos, 62794-9677
- Simmons Cooper Cancer Institute
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Estados Unidos, 46260
- St. Vincent Indianapolis Hospital
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
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Louisville, Kentucky, Estados Unidos, 40232
- Kosair Children's Hospital
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Louisiana
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Alexandria, Louisiana, Estados Unidos, 71315-3198
- Tulane Cancer Center Office of Clinical Research
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Maryland
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Baltimore, Maryland, Estados Unidos, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Michigan
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Detroit, Michigan, Estados Unidos, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Grand Rapids, Michigan, Estados Unidos, 49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods, Michigan, Estados Unidos, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Kalamazoo, Michigan, Estados Unidos, 49007-5381
- CCOP - Kalamazoo
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Lansing, Michigan, Estados Unidos, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Kansas City, Missouri, Estados Unidos, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Estados Unidos, 63104
- Cardinal Glennon Children's Hospital
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Saint Louis, Missouri, Estados Unidos, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89109-2306
- CCOP - Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Hackensack University Medical Center Cancer Center
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Morristown, New Jersey, Estados Unidos, 07962
- Overlook Hospital
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New Brunswick, New Jersey, Estados Unidos, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Paterson, New Jersey, Estados Unidos, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87131-5636
- University of New Mexico Cancer Center
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New York
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Bronx, New York, Estados Unidos, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Brooklyn, New York, Estados Unidos, 11219
- Maimonides Cancer Center at Maimonides Medical Center
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Buffalo, New York, Estados Unidos, 14263-0001
- Roswell Park Cancer Institute
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Mineola, New York, Estados Unidos, 11501
- Winthrop University Hospital
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New York, New York, Estados Unidos, 10065
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Estados Unidos, 10016
- NYU Cancer Institute at New York University Medical Center
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New York, New York, Estados Unidos, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Rochester, New York, Estados Unidos, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Stony Brook, New York, Estados Unidos, 11794-9446
- Stony Brook University Cancer Center
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Syracuse, New York, Estados Unidos, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Estados Unidos, 10595
- New York Medical College
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Charlotte, North Carolina, Estados Unidos, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Durham, North Carolina, Estados Unidos, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Estados Unidos, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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Ohio
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Akron, Ohio, Estados Unidos, 44308-1062
- Akron Children's Hospital
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Cincinnati, Ohio, Estados Unidos, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Estados Unidos, 44106-5000
- Rainbow Babies and Children's Hospital
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Columbus, Ohio, Estados Unidos, 43205-2696
- Nationwide Children's Hospital
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Dayton, Ohio, Estados Unidos, 45404-1815
- Dayton Children's - Dayton
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Toledo, Ohio, Estados Unidos, 43614
- Medical University of Ohio Cancer Center
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Youngstown, Ohio, Estados Unidos, 44501
- Tod Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Oklahoma University Cancer Institute
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Oregon
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Portland, Oregon, Estados Unidos, 97239-3098
- Knight Cancer Institute at Oregon Health and Science University
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Portland, Oregon, Estados Unidos, 97227
- Legacy Emanuel Hospital and Health Center and Children's Hospital
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033-0850
- Penn State Children's Hospital
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Philadelphia, Pennsylvania, Estados Unidos, 19134-1095
- St. Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Children's Hospital of Pittsburgh of UPMC
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Columbia, South Carolina, Estados Unidos, 29203
- Palmetto Health South Carolina Cancer Center
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Greenville, South Carolina, Estados Unidos, 29605
- Greenville Hospital Cancer Center
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Knoxville, Tennessee, Estados Unidos, 37901
- East Tennessee Children's Hospital
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Memphis, Tennessee, Estados Unidos, 38105
- St. Jude Children's Research Hospital
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Texas
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Amarillo, Texas, Estados Unidos, 79106
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
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Corpus Christi, Texas, Estados Unidos, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Estados Unidos, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, Estados Unidos, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, Estados Unidos, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Lubbock, Texas, Estados Unidos, 79410
- Covenant Children's Hospital
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San Antonio, Texas, Estados Unidos, 78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio, Texas, Estados Unidos, 78207
- University of Texas Health Science Center at San Antonio
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Temple, Texas, Estados Unidos, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Estados Unidos, 84113-1100
- Primary Children's Medical Center
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Vermont
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Burlington, Vermont, Estados Unidos, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Falls Church, Virginia, Estados Unidos, 22042-3300
- INOVA Fairfax Hospital
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Norfolk, Virginia, Estados Unidos, 23507-1971
- Children's Hospital of The King's Daughters
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Roanoke, Virginia, Estados Unidos, 24014
- Carilion Medical Center for Children at Roanoke Community Hospital
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Washington
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Seattle, Washington, Estados Unidos, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Spokane, Washington, Estados Unidos, 99220-2555
- Providence Cancer Center at Sacred Heart Medical Center
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West Virginia
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Charleston, West Virginia, Estados Unidos, 25302
- West Virginia University Health Sciences Center - Charleston
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Huntington, West Virginia, Estados Unidos, 25701
- Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
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Morgantown, West Virginia, Estados Unidos, 26506
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
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Wisconsin
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Green Bay, Wisconsin, Estados Unidos, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Madison, Wisconsin, Estados Unidos, 53792-6164
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Midwest Children's Cancer Center at Children's Hospital of Wisconsin
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Auckland, Nova Zelândia, 1
- Starship Children's Health
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Christchurch, Nova Zelândia, 8140
- Christchurch Hospital
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Wellington, Nova Zelândia, 6002
- Wellington Children's Hospital
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Santurce, Porto Rico, 00912
- San Jorge Children's Hospital
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Geneva, Suíça, 1205
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Suíça, 1011
- Swiss Pediatric Oncology Group Lausanne
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Marginal-failure Rate
Prazo: 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.
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Up to 5 years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression-free Survival Probability
Prazo: 3 years
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To estimate the progression-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.
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3 years
|
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Event-free Survival Probability
Prazo: 3 years
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To estimate the event-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation
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3 years
|
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Overall Survival Probability
Prazo: 3 years
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To estimate the overall survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.
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3 years
|
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Quality of Life (QOL)
Prazo: Up to 5 years
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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).
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Up to 5 years
|
|
MIB-1 Labeling Index Using Immunohistochemical Techniques With the MIB-1 Antibody According to Established Methods
Prazo: At baseline
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The MIB-1 labeling Index will be calculated as the percentage of tumor nuclei that are immunoreactive.
|
At baseline
|
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Correlation MIB-1 Labeling Index With PFS
Prazo: Up to 10 years
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The primary methods of analysis will be via stratified Cox regression
|
Up to 10 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Edward G. Shaw, MD, Wake Forest University Health Sciences
- Cadeira de estudo: Joel M. Cherlow, MD, Todd Cancer Institute at Long Beach Memorial Medical Center
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
- astrocitoma cerebelar infantil não tratado
- oligodendroglioma infantil
- astrocitoma cerebelar infantil recorrente
- astrocitoma cerebral infantil recorrente
- Via visual infantil recorrente e glioma hipotalâmico
- astrocitoma cerebral de baixo grau na infância
- via visual infantil não tratada e glioma hipotalâmico
Termos MeSH relevantes adicionais
- Doenças do Sistema Nervoso
- Neoplasias por Tipo Histológico
- Neoplasias
- Neoplasias por local
- Neoplasias Glandulares e Epiteliais
- Neoplasias Neuroepiteliais
- Tumores Neuroectodérmicos
- Neoplasias, Células Germinativas e Embrionárias
- Neoplasias, Tecido Nervoso
- Glioma
- Neoplasias do Sistema Nervoso
- Neoplasias do Sistema Nervoso Central
Outros números de identificação do estudo
- ACNS0221
- COG-ACNS0221 (Outro identificador: Clinical Trials.gov)
- CIRB-05016 (Outro identificador: Pediatric CIRB)
- CDR0000445095 (Outro identificador: Clinical Trials.gov)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .