Radiation Therapy in Treating Young Patients With Gliomas
2019년 7월 24일 업데이트: Children's Oncology Group
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
92
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Auckland, 뉴질랜드, 1
- Starship Children's Health
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Christchurch, 뉴질랜드, 8140
- Christchurch Hospital
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Wellington, 뉴질랜드, 6002
- Wellington Children's Hospital
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Alabama
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Birmingham, Alabama, 미국, 35294
- UAB Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, 미국, 85016-7710
- Phoenix Children's Hospital
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Arkansas
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Little Rock, Arkansas, 미국, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, 미국, 90027
- Southern California Permanente Medical Group
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Loma Linda, California, 미국, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, 미국, 90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, 미국, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
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Los Angeles, California, 미국, 90027
- Childrens Hospital Los Angeles
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Los Angeles, California, 미국, 90048-1865
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
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Madera, California, 미국, 93638-8762
- Children's Hospital Central California
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Oakland, California, 미국, 94609
- Children's Hospital and Research Center Oakland
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Orange, California, 미국, 92868
- Children's Hospital of Orange County
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Sacramento, California, 미국, 95817
- University of California Davis Cancer Center
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Sacramento, California, 미국, 95825
- Kaiser Permanente Medical Center - Oakland
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San Diego, California, 미국, 92123-4282
- Rady Children's Hospital - San Diego
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San Francisco, California, 미국, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Colorado
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Aurora, Colorado, 미국, 80045
- Children's Hospital Center for Cancer and Blood Disorders
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Denver, Colorado, 미국, 80218
- Presbyterian - St. Luke's Medical Center
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Connecticut
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Hartford, Connecticut, 미국, 06106
- Connecticut Children's Medical Center
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Delaware
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Wilmington, Delaware, 미국, 19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, 미국, 20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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Washington, District of Columbia, 미국, 20307-5001
- Walter Reed Army Medical Center
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Florida
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Fort Myers, Florida, 미국, 33901
- Lee Cancer Care of Lee Memorial Health System
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Hollywood, Florida, 미국, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Jacksonville, Florida, 미국, 32207
- Nemours Children's Clinic
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Miami, Florida, 미국, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, 미국, 33155
- Miami Children's Hospital
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Orlando, Florida, 미국, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Orlando, Florida, 미국, 32806
- Nemours Children's Clinic - Orlando
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Orlando, Florida, 미국, 32806
- M.D. Anderson Cancer Center at Orlando
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Pensacola, Florida, 미국, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Saint Petersburg, Florida, 미국, 33701
- All Children's Hospital
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Tampa, Florida, 미국, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, 미국, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, 미국, 30322
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
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Augusta, Georgia, 미국, 30912-3730
- MBCCOP - Medical College of Georgia Cancer Center
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Hawaii
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Honolulu, Hawaii, 미국, 96813
- Cancer Research Center of Hawaii
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Idaho
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Boise, Idaho, 미국, 83712-6297
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
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Illinois
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Chicago, Illinois, 미국, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, 미국, 60612-7243
- University of Illinois Cancer Center
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Oak Lawn, Illinois, 미국, 60453
- Keyser Family Cancer Center at Advocate Hope Children's Hospital
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Park Ridge, Illinois, 미국, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Peoria, Illinois, 미국, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, 미국, 62794-9677
- Simmons Cooper Cancer Institute
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Indiana
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Indianapolis, Indiana, 미국, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, 미국, 46260
- St. Vincent Indianapolis Hospital
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Iowa
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Iowa City, Iowa, 미국, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Lexington, Kentucky, 미국, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
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Louisville, Kentucky, 미국, 40232
- Kosair Children's Hospital
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Louisiana
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Alexandria, Louisiana, 미국, 71315-3198
- Tulane Cancer Center Office of Clinical Research
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Maryland
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Baltimore, Maryland, 미국, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Michigan
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Detroit, Michigan, 미국, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Grand Rapids, Michigan, 미국, 49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods, Michigan, 미국, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Kalamazoo, Michigan, 미국, 49007-5381
- CCOP - Kalamazoo
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Lansing, Michigan, 미국, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, 미국, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, 미국, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Kansas City, Missouri, 미국, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, 미국, 63104
- Cardinal Glennon Children's Hospital
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Saint Louis, Missouri, 미국, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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Nevada
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Las Vegas, Nevada, 미국, 89109-2306
- CCOP - Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, 미국, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, 미국, 07601
- Hackensack University Medical Center Cancer Center
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Morristown, New Jersey, 미국, 07962
- Overlook Hospital
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New Brunswick, New Jersey, 미국, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Paterson, New Jersey, 미국, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, 미국, 87131-5636
- University of New Mexico Cancer Center
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New York
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Bronx, New York, 미국, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Brooklyn, New York, 미국, 11219
- Maimonides Cancer Center at Maimonides Medical Center
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Buffalo, New York, 미국, 14263-0001
- Roswell Park Cancer Institute
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Mineola, New York, 미국, 11501
- Winthrop University Hospital
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New York, New York, 미국, 10065
- Memorial Sloan-Kettering Cancer Center
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New York, New York, 미국, 10016
- NYU Cancer Institute at New York University Medical Center
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New York, New York, 미국, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Rochester, New York, 미국, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Stony Brook, New York, 미국, 11794-9446
- Stony Brook University Cancer Center
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Syracuse, New York, 미국, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, 미국, 10595
- New York Medical College
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Charlotte, North Carolina, 미국, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Durham, North Carolina, 미국, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, 미국, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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Ohio
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Akron, Ohio, 미국, 44308-1062
- Akron Children's Hospital
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Cincinnati, Ohio, 미국, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, 미국, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, 미국, 44106-5000
- Rainbow Babies and Children's Hospital
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Columbus, Ohio, 미국, 43205-2696
- Nationwide Children's Hospital
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Dayton, Ohio, 미국, 45404-1815
- Dayton Children's - Dayton
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Toledo, Ohio, 미국, 43614
- Medical University of Ohio Cancer Center
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Youngstown, Ohio, 미국, 44501
- Tod Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73104
- Oklahoma University Cancer Institute
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Oregon
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Portland, Oregon, 미국, 97239-3098
- Knight Cancer Institute at Oregon Health and Science University
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Portland, Oregon, 미국, 97227
- Legacy Emanuel Hospital and Health Center and Children's Hospital
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Pennsylvania
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Hershey, Pennsylvania, 미국, 17033-0850
- Penn State Children's Hospital
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Philadelphia, Pennsylvania, 미국, 19134-1095
- St. Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, 미국, 15213
- Children's Hospital of Pittsburgh of UPMC
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Rhode Island
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Providence, Rhode Island, 미국, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Charleston, South Carolina, 미국, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Columbia, South Carolina, 미국, 29203
- Palmetto Health South Carolina Cancer Center
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Greenville, South Carolina, 미국, 29605
- Greenville Hospital Cancer Center
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South Dakota
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Sioux Falls, South Dakota, 미국, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Knoxville, Tennessee, 미국, 37901
- East Tennessee Children's Hospital
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Memphis, Tennessee, 미국, 38105
- St. Jude Children's Research Hospital
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Texas
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Amarillo, Texas, 미국, 79106
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
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Corpus Christi, Texas, 미국, 78411
- Driscoll Children's Hospital
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Dallas, Texas, 미국, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, 미국, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, 미국, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Lubbock, Texas, 미국, 79410
- Covenant Children's Hospital
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San Antonio, Texas, 미국, 78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio, Texas, 미국, 78207
- University of Texas Health Science Center at San Antonio
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Temple, Texas, 미국, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, 미국, 84113-1100
- Primary Children's Medical Center
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Vermont
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Burlington, Vermont, 미국, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Falls Church, Virginia, 미국, 22042-3300
- INOVA Fairfax Hospital
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Norfolk, Virginia, 미국, 23507-1971
- Children's Hospital of The King's Daughters
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Roanoke, Virginia, 미국, 24014
- Carilion Medical Center for Children at Roanoke Community Hospital
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Washington
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Seattle, Washington, 미국, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Spokane, Washington, 미국, 99220-2555
- Providence Cancer Center at Sacred Heart Medical Center
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West Virginia
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Charleston, West Virginia, 미국, 25302
- West Virginia University Health Sciences Center - Charleston
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Huntington, West Virginia, 미국, 25701
- Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
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Morgantown, West Virginia, 미국, 26506
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
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Wisconsin
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Green Bay, Wisconsin, 미국, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Madison, Wisconsin, 미국, 53792-6164
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
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Milwaukee, Wisconsin, 미국, 53226
- Midwest Children's Cancer Center at Children's Hospital of Wisconsin
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Geneva, 스위스, 1205
- Swiss Pediatric Oncology Group Geneva
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Lausanne, 스위스, 1011
- Swiss Pediatric Oncology Group Lausanne
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Quebec, 캐나다, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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British Columbia
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Vancouver, British Columbia, 캐나다, V6H 3V4
- Children's & Women's Hospital of British Columbia
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Manitoba
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Winnipeg, Manitoba, 캐나다, R3E 0V9
- CancerCare Manitoba
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3J 3G9
- IWK Health Centre
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Ontario
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Hamilton, Ontario, 캐나다, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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London, Ontario, 캐나다, N6A 5W9
- Children's Hospital of Western Ontario
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Ottawa, Ontario, 캐나다, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, 캐나다, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, 캐나다, H3T 1C5
- Hôpital Sainte Justine
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Saskatchewan
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Saskatoon, Saskatchewan, 캐나다, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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Santurce, 푸에르토 리코, 00912
- San Jorge Children's Hospital
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Queensland
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Brisbane, Queensland, 호주, 4029
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, 호주, 6001
- Princess Margaret Hospital for Children
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
3년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Marginal-failure Rate
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-free Survival Probability
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: Up to 10 years
|
The primary methods of analysis will be via stratified Cox regression
|
Up to 10 years
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Edward G. Shaw, MD, Wake Forest University Health Sciences
- 연구 의자: Joel M. Cherlow, MD, Todd Cancer Institute at Long Beach Memorial Medical Center
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2006년 11월 1일
기본 완료 (실제)
2013년 12월 30일
연구 완료 (실제)
2018년 12월 31일
연구 등록 날짜
최초 제출
2005년 10월 12일
QC 기준을 충족하는 최초 제출
2005년 10월 12일
처음 게시됨 (추정)
2005년 10월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 8월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 7월 24일
마지막으로 확인됨
2016년 11월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- ACNS0221
- COG-ACNS0221 (기타 식별자: Clinical Trials.gov)
- CIRB-05016 (기타 식별자: Pediatric CIRB)
- CDR0000445095 (기타 식별자: Clinical Trials.gov)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .