Chemotherapy and Radiation Therapy After Surgery in Treating Children With Newly Diagnosed Astrocytoma, Glioblastoma Multiforme, Gliosarcoma, or Diffuse Intrinsic Pontine Glioma
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- Registration Number
- NCT00028795
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving chemotherapy together with radiation therapy after surgery followed by chemotherapy alone works in children with newly diagnosed astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma.
- Detailed Description
OBJECTIVES:
* Compare the event-free survival of patients with newly diagnosed anaplastic astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma (DIPG) treated with adjuvant temozolomide administered concurrently with postoperative radiotherapy and then alone as maintenance therapy vs historical control cohorts treated in prior Pediatric Oncology Group and Children's Cancer Group studies.
* Determine the toxicity of this regimen in these patients.
* Determine the efficacy of this regimen in patients with DIPG.
* Determine the toxicity of this regimen in patients with DIPG.
OUTLINE: This is a multicenter study.
* Adjuvant chemoradiotherapy: Beginning within 6 weeks after surgical resection or diagnosis\*, patients without gross residual disease undergo cranial irradiation 5 days a week for 6 weeks. Beginning within 6 weeks after surgical resection, patients with gross residual disease undergo radiotherapy as above followed by boost radiotherapy for 1 week. All patients receive oral temozolomide once daily beginning within 5 days after initiation of radiotherapy and continuing for a total of 6 weeks in the absence of disease progression or unacceptable toxicity.
* Adjuvant maintenance therapy: Beginning 4 weeks after completion of adjuvant chemoradiotherapy, patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity.
NOTE: \*For patients with diffuse intrinsic pontine glioma only
Patients are followed every 3-6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 50-60 patients will be accrued for this study within 12-14 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chemoradiotherapy temozolomide - Chemoradiotherapy adjuvant therapy - Chemoradiotherapy radiation therapy -
- Primary Outcome Measures
Name Time Method Improved outcome Toxicity as assessed by NCI CTCAE v. 2.0
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (229)
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Illinois Medical Center
🇺🇸Chicago, Illinois, United States
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Swiss Pediatric Oncology Group Lausanne
🇨🇭Lausanne, Switzerland
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Joe DiMaggio Children's Hospital at Memorial
🇺🇸Hollywood, Florida, United States
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
MBCCOP-Medical College of Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
Children's Hospital of Southwest Florida
🇺🇸Fort Myers, Florida, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
University of South Alabama Cancer Research Institute
🇺🇸Mobile, Alabama, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
Medical Center of Central Georgia
🇺🇸Macon, Georgia, United States
Sacred Heart Children's Hospital
🇺🇸Pensacola, Florida, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
🇺🇸Atlanta, Georgia, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
🇺🇸Tulsa, Oklahoma, United States
Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Breslin Cancer Center at Ingham Regional Medical Center
🇺🇸Lansing, Michigan, United States
University of New Mexico Cancer Research and Treatment Center
🇺🇸Albuquerque, New Mexico, United States
Brooklyn Hospital Center
🇺🇸Brooklyn, New York, United States
St. Mary's - Duluth Clinic Cancer Center
🇺🇸Duluth, Minnesota, United States
Brookdale University Hospital and Medical Center
🇺🇸Brooklyn, New York, United States
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Lutheran General Cancer Care Center
🇺🇸Park Ridge, Illinois, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Pediatric Specialty Clinic at Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
Children's Hospital at Albany Medical Center
🇺🇸Albany, New York, United States
Floating Hospital for Children
🇺🇸Boston, Massachusetts, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Children's Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Columbus Children's Hospital
🇺🇸Columbus, Ohio, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Mission Hospitals - Memorial Campus
🇺🇸Asheville, North Carolina, United States
Covenant Children's Hospital
🇺🇸Lubbock, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
🇺🇸Lackland Air Force Base, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Center for Cancer Prevention and Care at Scott and White Clinic
🇺🇸Temple, Texas, United States
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Naval Medical Center - Portsmouth
🇺🇸Portsmouth, Virginia, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Montreal Children's Hospital at McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Baptist-South Miami Regional Cancer Program
🇺🇸Miami, Florida, United States
Riley Children Cancer Center at Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
St. Vincent Hospitals and Health Care Centers
🇺🇸Indianapolis, Indiana, United States
Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
🇺🇸San Diego, California, United States
Children's Hospital and Health Center - San Diego
🇺🇸San Diego, California, United States
Children's Hospitals and Clinics - Minneapolis/St. Paul
🇺🇸Minneapolis, Minnesota, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Huntsman Cancer Institute at University of Utah
🇺🇸Salt Lake City, Utah, United States
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Dakota Cancer Institute at Innovis Health - Dakota Clinic
🇺🇸Fargo, North Dakota, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Comprehensive Cancer Center at University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Children's Hospital at Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Children's Hospital Cancer Center
🇺🇸Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center
🇺🇸Denver, Colorado, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
🇺🇸Portland, Oregon, United States
Doernbecher Children's Hospital at Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
St. Joseph's Children's Hospital of Tampa
🇺🇸Tampa, Florida, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Children's Hospital of Omaha
🇺🇸Omaha, Nebraska, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Santa Barbara Cottage Hospital
🇺🇸Santa Barbara, California, United States
Kaplan Cancer Center at St. Mary's Medical Center
🇺🇸West Palm Beach, Florida, United States
Advocate Hope Children's Hospital
🇺🇸Oak Lawn, Illinois, United States
DeVos Children's Hospital
🇺🇸Grand Rapids, Michigan, United States
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
🇺🇸Greenville, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Toledo Children's Hospital
🇺🇸Toledo, Ohio, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Tod Children's Hospital - Forum Health
🇺🇸Youngstown, Ohio, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
M.D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
MBCCOP - South Texas Pediatrics
🇺🇸San Antonio, Texas, United States
Mary Bridge Children's Hospital and Health Center - Tacoma
🇺🇸Tacoma, Washington, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Comprehensive Cancer Center at Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
Schneider Children's Hospital
🇺🇸New Hyde Park, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
🇺🇸Long Beach, California, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States
Children's Hospital Central California
🇺🇸Madera, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸Orange, California, United States
Children's Hospital and Research Center at Oakland
🇺🇸Oakland, California, United States
Lucile Packard Children's Hospital at Stanford University Medical Center
🇺🇸Palo Alto, California, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
🇺🇸Santa Clara, California, United States
General Robert Huyser Cancer Center at David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
St. Luke's Mountain States Tumor Institute - Boise
🇺🇸Boise, Idaho, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Saint Jude Midwest Affiliate
🇺🇸Peoria, Illinois, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
🇺🇸Baltimore, Maryland, United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
🇺🇸Springfield, Massachusetts, United States
Walter Reed Army Medical Center
🇺🇸Silver Spring, Maryland, United States
UMASS Memorial Cancer Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Penn State Children's Hospital
🇺🇸Hershey, Pennsylvania, United States
Palmetto Health South Carolina Cancer Center
🇺🇸Columbia, South Carolina, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
East Tennessee Children's Hospital
🇺🇸Knoxville, Tennessee, United States
Texas Tech University Health Sciences Center School of Medicine
🇺🇸Amarillo, Texas, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
Methodist Cancer Center at Methodist Specialty and Transplant Hospital
🇺🇸San Antonio, Texas, United States
Vermont Cancer Center at University of Vermont
🇺🇸Burlington, Vermont, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
INOVA Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Children's Hospital of the King's Daughters
🇺🇸Norfolk, Virginia, United States
Carilion Medical Center for Children at Roanoke Community Hospital
🇺🇸Roanoke, Virginia, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
🇺🇸Charleston, West Virginia, United States
Cabell Huntington Hospital
🇺🇸Huntington, West Virginia, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
Bellin Memorial Hospital
🇺🇸Green Bay, Wisconsin, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
Children's Hospital at Westmead
🇦🇺Westmead, New South Wales, Australia
Sydney Children's Hospital
🇦🇺Randwick, New South Wales, Australia
Women's and Children's Hospital
🇦🇺North Adelaide, South Australia, Australia
Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Cross Cancer Institute at University of Alberta
🇨🇦Edmonton, Alberta, Canada
British Columbia Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
Janeway Children's Health and Rehabilitation Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
McMaster Children's Hospital at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Centre de Recherche du Centre Hospitalier de l'Universite Laval
🇨🇦Sainte Foy, Quebec, Canada
Children's Hospital of Western Ontario
🇨🇦London, Ontario, Canada
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Allan Blair Cancer Centre at Pasqua Hospital
🇨🇦Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
San Jorge Children's Hospital
🇵🇷Santurce, Puerto Rico
Starship Children's Health
🇳🇿Auckland, New Zealand
Swiss Pediatric Oncology Group Geneva
🇨🇭Geneva, Switzerland
Swiss Pediatric Oncology Group Bern
🇨🇭Bern, Switzerland
Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
🇵🇷San Juan, Puerto Rico
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Deaconess Medical Center
🇺🇸Spokane, Washington, United States
Long Island Cancer Center at Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Kaiser Permanente Medical Center - Sacramento
🇺🇸Sacramento, California, United States
Yale Comprehensive Cancer Center
🇺🇸New Haven, Connecticut, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Nemours Children's Clinic-Orlando
🇺🇸Orlando, Florida, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Maine Children's Cancer Program
🇺🇸Scarborough, Maine, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Lombardi Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Valerie Fund Children's Center at Atlantic Health
🇺🇸Summit, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
St. Joseph's Hospital and Medical Center
🇺🇸Paterson, New Jersey, United States
Vanderbilt Children's Hospital
🇺🇸Nashville, Tennessee, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Children's Hospital of Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
East Tennessee State University Cancer Center at Johnson City Medical Center
🇺🇸Johnson City, Tennessee, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Tulane Cancer Center at Tulane University Hospital and Clinic
🇺🇸New Orleans, Louisiana, United States
Children's Hospital of New Orleans
🇺🇸New Orleans, Louisiana, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Children's Hospital of Austin
🇺🇸Austin, Texas, United States
Massey Cancer Center at Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Blank Children's Hospital
🇺🇸Des Moines, Iowa, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States