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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Alabama
-
Birmingham、Alabama、アメリカ、35294
- UAB Comprehensive Cancer Center
-
-
Arizona
-
Phoenix、Arizona、アメリカ、85016-7710
- Phoenix Children's Hospital
-
-
Arkansas
-
Little Rock、Arkansas、アメリカ、72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
-
-
California
-
Downey、California、アメリカ、90027
- Southern California Permanente Medical Group
-
Loma Linda、California、アメリカ、92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
-
Long Beach、California、アメリカ、90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
-
Los Angeles、California、アメリカ、90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
-
Los Angeles、California、アメリカ、90027
- Childrens Hospital Los Angeles
-
Los Angeles、California、アメリカ、90048-1865
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
-
Madera、California、アメリカ、93638-8762
- Children's Hospital Central California
-
Oakland、California、アメリカ、94609
- Children's Hospital and Research Center Oakland
-
Orange、California、アメリカ、92868
- Children's Hospital of Orange County
-
Sacramento、California、アメリカ、95817
- University of California Davis Cancer Center
-
Sacramento、California、アメリカ、95825
- Kaiser Permanente Medical Center - Oakland
-
San Diego、California、アメリカ、92123-4282
- Rady Children's Hospital - San Diego
-
San Francisco、California、アメリカ、94115
- UCSF Helen Diller Family Comprehensive Cancer Center
-
-
Colorado
-
Aurora、Colorado、アメリカ、80045
- Children's Hospital Center for Cancer and Blood Disorders
-
Denver、Colorado、アメリカ、80218
- Presbyterian - St. Luke's Medical Center
-
-
Connecticut
-
Hartford、Connecticut、アメリカ、06106
- Connecticut Children's Medical Center
-
-
Delaware
-
Wilmington、Delaware、アメリカ、19803
- Alfred I. DuPont Hospital for Children
-
-
District of Columbia
-
Washington、District of Columbia、アメリカ、20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
-
Washington、District of Columbia、アメリカ、20307-5001
- Walter Reed Army Medical Center
-
-
Florida
-
Fort Myers、Florida、アメリカ、33901
- Lee Cancer Care of Lee Memorial Health System
-
Hollywood、Florida、アメリカ、33021
- Memorial Cancer Institute at Memorial Regional Hospital
-
Jacksonville、Florida、アメリカ、32207
- Nemours Children's Clinic
-
Miami、Florida、アメリカ、33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
-
Miami、Florida、アメリカ、33155
- Miami Children's Hospital
-
Orlando、Florida、アメリカ、32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
-
Orlando、Florida、アメリカ、32806
- Nemours Children's Clinic - Orlando
-
Orlando、Florida、アメリカ、32806
- M.D. Anderson Cancer Center at Orlando
-
Pensacola、Florida、アメリカ、32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
-
Saint Petersburg、Florida、アメリカ、33701
- All Children's Hospital
-
Tampa、Florida、アメリカ、33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
-
West Palm Beach、Florida、アメリカ、33407
- Kaplan Cancer Center at St. Mary's Medical Center
-
-
Georgia
-
Atlanta、Georgia、アメリカ、30322
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
-
Augusta、Georgia、アメリカ、30912-3730
- MBCCOP - Medical College of Georgia Cancer Center
-
-
Hawaii
-
Honolulu、Hawaii、アメリカ、96813
- Cancer Research Center of Hawaii
-
-
Idaho
-
Boise、Idaho、アメリカ、83712-6297
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
-
-
Illinois
-
Chicago、Illinois、アメリカ、60637-1470
- University of Chicago Cancer Research Center
-
Chicago、Illinois、アメリカ、60612-7243
- University of Illinois Cancer Center
-
Oak Lawn、Illinois、アメリカ、60453
- Keyser Family Cancer Center at Advocate Hope Children's Hospital
-
Park Ridge、Illinois、アメリカ、60068-1174
- Advocate Lutheran General Cancer Care Center
-
Peoria、Illinois、アメリカ、61637
- Saint Jude Midwest Affiliate
-
Springfield、Illinois、アメリカ、62794-9677
- Simmons Cooper Cancer Institute
-
-
Indiana
-
Indianapolis、Indiana、アメリカ、46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
-
Indianapolis、Indiana、アメリカ、46260
- St. Vincent Indianapolis Hospital
-
-
Iowa
-
Iowa City、Iowa、アメリカ、52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
-
-
Kentucky
-
Lexington、Kentucky、アメリカ、40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
-
Louisville、Kentucky、アメリカ、40232
- Kosair Children's Hospital
-
-
Louisiana
-
Alexandria、Louisiana、アメリカ、71315-3198
- Tulane Cancer Center Office of Clinical Research
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
-
-
Michigan
-
Detroit、Michigan、アメリカ、48201-1379
- Barbara Ann Karmanos Cancer Institute
-
Grand Rapids、Michigan、アメリカ、49503-2560
- Butterworth Hospital at Spectrum Health
-
Grosse Pointe Woods、Michigan、アメリカ、48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
-
Kalamazoo、Michigan、アメリカ、49007-5381
- CCOP - Kalamazoo
-
Lansing、Michigan、アメリカ、48910
- Breslin Cancer Center at Ingham Regional Medical Center
-
-
Minnesota
-
Minneapolis、Minnesota、アメリカ、55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
-
Rochester、Minnesota、アメリカ、55905
- Mayo Clinic Cancer Center
-
-
Mississippi
-
Jackson、Mississippi、アメリカ、39216-4505
- University of Mississippi Cancer Clinic
-
-
Missouri
-
Kansas City、Missouri、アメリカ、64108
- Children's Mercy Hospital
-
Saint Louis、Missouri、アメリカ、63104
- Cardinal Glennon Children's Hospital
-
Saint Louis、Missouri、アメリカ、63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
-
-
Nevada
-
Las Vegas、Nevada、アメリカ、89109-2306
- CCOP - Nevada Cancer Research Foundation
-
-
New Hampshire
-
Lebanon、New Hampshire、アメリカ、03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
-
-
New Jersey
-
Hackensack、New Jersey、アメリカ、07601
- Hackensack University Medical Center Cancer Center
-
Morristown、New Jersey、アメリカ、07962
- Overlook Hospital
-
New Brunswick、New Jersey、アメリカ、08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
-
Paterson、New Jersey、アメリカ、07503
- St. Joseph's Hospital and Medical Center
-
-
New Mexico
-
Albuquerque、New Mexico、アメリカ、87131-5636
- University of New Mexico Cancer Center
-
-
New York
-
Bronx、New York、アメリカ、10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
-
Brooklyn、New York、アメリカ、11219
- Maimonides Cancer Center at Maimonides Medical Center
-
Buffalo、New York、アメリカ、14263-0001
- Roswell Park Cancer Institute
-
Mineola、New York、アメリカ、11501
- Winthrop University Hospital
-
New York、New York、アメリカ、10065
- Memorial Sloan-Kettering Cancer Center
-
New York、New York、アメリカ、10016
- NYU Cancer Institute at New York University Medical Center
-
New York、New York、アメリカ、10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
-
Rochester、New York、アメリカ、14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
-
Stony Brook、New York、アメリカ、11794-9446
- Stony Brook University Cancer Center
-
Syracuse、New York、アメリカ、13210
- SUNY Upstate Medical University Hospital
-
Valhalla、New York、アメリカ、10595
- New York Medical College
-
-
North Carolina
-
Chapel Hill、North Carolina、アメリカ、27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
-
Charlotte、North Carolina、アメリカ、28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
-
Durham、North Carolina、アメリカ、27710
- Duke Comprehensive Cancer Center
-
Winston-Salem、North Carolina、アメリカ、27157-1096
- Wake Forest University Comprehensive Cancer Center
-
-
Ohio
-
Akron、Ohio、アメリカ、44308-1062
- Akron Children's Hospital
-
Cincinnati、Ohio、アメリカ、45229-3039
- Cincinnati Children's Hospital Medical Center
-
Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland、Ohio、アメリカ、44106-5000
- Rainbow Babies and Children's Hospital
-
Columbus、Ohio、アメリカ、43205-2696
- Nationwide Children's Hospital
-
Dayton、Ohio、アメリカ、45404-1815
- Dayton Children's - Dayton
-
Toledo、Ohio、アメリカ、43614
- Medical University of Ohio Cancer Center
-
Youngstown、Ohio、アメリカ、44501
- Tod Children's Hospital
-
-
Oklahoma
-
Oklahoma City、Oklahoma、アメリカ、73104
- Oklahoma University Cancer Institute
-
-
Oregon
-
Portland、Oregon、アメリカ、97239-3098
- Knight Cancer Institute At Oregon Health and Science University
-
Portland、Oregon、アメリカ、97227
- Legacy Emanuel Hospital and Health Center and Children's Hospital
-
-
Pennsylvania
-
Hershey、Pennsylvania、アメリカ、17033-0850
- Penn State Children's Hospital
-
Philadelphia、Pennsylvania、アメリカ、19134-1095
- St. Christopher's Hospital for Children
-
Pittsburgh、Pennsylvania、アメリカ、15213
- Children's Hospital of Pittsburgh of UPMC
-
-
Rhode Island
-
Providence、Rhode Island、アメリカ、02903
- Rhode Island Hospital Comprehensive Cancer Center
-
-
South Carolina
-
Charleston、South Carolina、アメリカ、29425
- Hollings Cancer Center at Medical University of South Carolina
-
Columbia、South Carolina、アメリカ、29203
- Palmetto Health South Carolina Cancer Center
-
Greenville、South Carolina、アメリカ、29605
- Greenville Hospital Cancer Center
-
-
South Dakota
-
Sioux Falls、South Dakota、アメリカ、57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
-
Tennessee
-
Knoxville、Tennessee、アメリカ、37901
- East Tennessee Children's Hospital
-
Memphis、Tennessee、アメリカ、38105
- St. Jude Children's Research Hospital
-
-
Texas
-
Amarillo、Texas、アメリカ、79106
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
-
Corpus Christi、Texas、アメリカ、78411
- Driscoll Children's Hospital
-
Dallas、Texas、アメリカ、75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
-
Fort Worth、Texas、アメリカ、76104
- Cook Children's Medical Center - Fort Worth
-
Houston、Texas、アメリカ、77030-4009
- M. D. Anderson Cancer Center at University of Texas
-
Lubbock、Texas、アメリカ、79410
- Covenant Children's Hospital
-
San Antonio、Texas、アメリカ、78229-3993
- Methodist Children's Hospital of South Texas
-
San Antonio、Texas、アメリカ、78207
- University of Texas Health Science Center at San Antonio
-
Temple、Texas、アメリカ、76508
- CCOP - Scott and White Hospital
-
-
Utah
-
Salt Lake City、Utah、アメリカ、84113-1100
- Primary Children's Medical Center
-
-
Vermont
-
Burlington、Vermont、アメリカ、05401
- Fletcher Allen Health Care - University Health Center Campus
-
-
Virginia
-
Falls Church、Virginia、アメリカ、22042-3300
- Inova Fairfax Hospital
-
Norfolk、Virginia、アメリカ、23507-1971
- Children's Hospital of The King's Daughters
-
Roanoke、Virginia、アメリカ、24014
- Carilion Medical Center for Children at Roanoke Community Hospital
-
-
Washington
-
Seattle、Washington、アメリカ、98105
- Children's Hospital and Regional Medical Center - Seattle
-
Spokane、Washington、アメリカ、99220-2555
- Providence Cancer Center at Sacred Heart Medical Center
-
-
West Virginia
-
Charleston、West Virginia、アメリカ、25302
- West Virginia University Health Sciences Center - Charleston
-
Huntington、West Virginia、アメリカ、25701
- Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
-
Morgantown、West Virginia、アメリカ、26506
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
-
-
Wisconsin
-
Green Bay、Wisconsin、アメリカ、54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Madison、Wisconsin、アメリカ、53792-6164
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
-
Milwaukee、Wisconsin、アメリカ、53226
- Midwest Children's Cancer Center at Children's Hospital of Wisconsin
-
-
-
-
Queensland
-
Brisbane、Queensland、オーストラリア、4029
- Royal Children's Hospital
-
-
Western Australia
-
Perth、Western Australia、オーストラリア、6001
- Princess Margaret Hospital for Children
-
-
-
-
-
Quebec、カナダ、G1V 4G2
- Centre Hospitalier Universitaire de Quebec
-
-
British Columbia
-
Vancouver、British Columbia、カナダ、V6H 3V4
- Children's & Women's Hospital of British Columbia
-
-
Manitoba
-
Winnipeg、Manitoba、カナダ、R3E 0V9
- CancerCare Manitoba
-
-
Nova Scotia
-
Halifax、Nova Scotia、カナダ、B3J 3G9
- IWK Health Centre
-
-
Ontario
-
Hamilton、Ontario、カナダ、L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
-
London、Ontario、カナダ、N6A 5W9
- Children's Hospital of Western Ontario
-
Ottawa、Ontario、カナダ、K1H 8L1
- Children's Hospital of Eastern Ontario
-
Toronto、Ontario、カナダ、M5G 1X8
- Hospital for Sick Children
-
-
Quebec
-
Montreal、Quebec、カナダ、H3T 1C5
- Hopital Sainte Justine
-
-
Saskatchewan
-
Saskatoon、Saskatchewan、カナダ、S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
-
-
-
-
-
Geneva、スイス、1205
- Swiss Pediatric Oncology Group Geneva
-
Lausanne、スイス、1011
- Swiss Pediatric Oncology Group Lausanne
-
-
-
-
-
Auckland、ニュージーランド、1
- Starship Children's Health
-
Christchurch、ニュージーランド、8140
- ChristChurch Hospital
-
Wellington、ニュージーランド、6002
- Wellington Children's Hospital
-
-
-
-
-
Santurce、プエルトリコ、00912
- San Jorge Children's Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的: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
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Marginal-failure Rate
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Progression-free Survival Probability
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠: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
時間枠:Up to 10 years
|
The primary methods of analysis will be via stratified Cox regression
|
Up to 10 years
|
協力者と研究者
捜査官
- スタディチェア:Edward G. Shaw, MD、Wake Forest University Health Sciences
- スタディチェア:Joel M. Cherlow, MD、Todd Cancer Institute at Long Beach Memorial Medical Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- ACNS0221
- COG-ACNS0221 (その他の識別子:Clinical Trials.gov)
- CIRB-05016 (その他の識別子:Pediatric CIRB)
- CDR0000445095 (その他の識別子:Clinical Trials.gov)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
radiation therapyの臨床試験
-
Universitätsklinikum Hamburg-EppendorfCytoSorbents, Inc募集
-
Universitätsklinikum Hamburg-Eppendorf完了
-
Advanced Cooling Therapy, Inc., d/b/a Attune MedicalDnipropetrovsk State Medical Academy完了