Radiation Therapy in Treating Young Patients With Gliomas

Phase 2

Completed

Conditions: Brain Tumor
Central Nervous System Tumor

Interventions: Radiation: radiation therapy

Registration Number: NCT00238264

Lead Sponsor: Children's Oncology Group

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (radiotherapy)	radiation therapy	Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Marginal-failure Rate	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.

Secondary Outcome Measures

Name	Time	Method
Correlation MIB-1 Labeling Index With PFS	Up to 10 years	The primary methods of analysis will be via stratified Cox regression
Quality of Life (QOL)	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).
Overall Survival Probability	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.
Progression-free Survival Probability	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.
Event-free Survival Probability	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
MIB-1 Labeling Index Using Immunohistochemical Techniques With the MIB-1 Antibody According to Established Methods	At baseline	The MIB-1 labeling Index will be calculated as the percentage of tumor nuclei that are immunoreactive.

Trial Locations

Locations (145): Nationwide Children's Hospital
🇺🇸
Columbus, Ohio, United States
Children's Hospital Central California
🇺🇸
Madera, California, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸
Seattle, Washington, United States
MBCCOP - Medical College of Georgia Cancer Center
🇺🇸
Augusta, Georgia, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
🇺🇸
Atlanta, Georgia, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸
Iowa City, Iowa, United States
Tulane Cancer Center Office of Clinical Research
🇺🇸
Alexandria, Louisiana, United States
Saint Jude Midwest Affiliate
🇺🇸
Peoria, Illinois, United States
Simmons Cooper Cancer Institute
🇺🇸
Springfield, Illinois, United States
Maimonides Cancer Center at Maimonides Medical Center
🇺🇸
Brooklyn, New York, United States
Keyser Family Cancer Center at Advocate Hope Children's Hospital
🇺🇸
Oak Lawn, Illinois, United States
University of Illinois Cancer Center
🇺🇸
Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸
Chicago, Illinois, United States
NYU Cancer Institute at New York University Medical Center
🇺🇸
New York, New York, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
University of Mississippi Cancer Clinic
🇺🇸
Jackson, Mississippi, United States
Children's Hospital of Western Ontario
🇨🇦
London, Ontario, Canada
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
🇺🇸
Baltimore, Maryland, United States
SUNY Upstate Medical University Hospital
🇺🇸
Syracuse, New York, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
🇺🇸
Boise, Idaho, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸
Cleveland, Ohio, United States
Overlook Hospital
🇺🇸
Morristown, New Jersey, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸
Rochester, New York, United States
Inova Fairfax Hospital
🇺🇸
Falls Church, Virginia, United States
Akron Children's Hospital
🇺🇸
Akron, Ohio, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸
Charlotte, North Carolina, United States
Rainbow Babies and Children's Hospital
🇺🇸
Cleveland, Ohio, United States
Roswell Park Cancer Institute
🇺🇸
Buffalo, New York, United States
Hackensack University Medical Center Cancer Center
🇺🇸
Hackensack, New Jersey, United States
Starship Children's Health
🇳🇿
Auckland, New Zealand
Stony Brook University Cancer Center
🇺🇸
Stony Brook, New York, United States
Christchurch Hospital
🇳🇿
Christchurch, New Zealand
Wellington Children's Hospital
🇳🇿
Wellington, New Zealand
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
🇺🇸
New York, New York, United States
Hospital for Sick Children
🇨🇦
Toronto, Ontario, Canada
Driscoll Children's Hospital
🇺🇸
Corpus Christi, Texas, United States
Carilion Medical Center for Children at Roanoke Community Hospital
🇺🇸
Roanoke, Virginia, United States
Royal Children's Hospital
🇦🇺
Brisbane, Queensland, Australia
Children's & Women's Hospital of British Columbia
🇨🇦
Vancouver, British Columbia, Canada
McMaster Children's Hospital at Hamilton Health Sciences
🇨🇦
Hamilton, Ontario, Canada
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸
Indianapolis, Indiana, United States
St. Vincent Indianapolis Hospital
🇺🇸
Indianapolis, Indiana, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸
Las Vegas, Nevada, United States
Rady Children's Hospital - San Diego
🇺🇸
San Diego, California, United States
Cincinnati Children's Hospital Medical Center
🇺🇸
Cincinnati, Ohio, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
🇺🇸
Minneapolis, Minnesota, United States
Princess Margaret Hospital for Children
🇦🇺
Perth, Western Australia, Australia
CancerCare Manitoba
🇨🇦
Winnipeg, Manitoba, Canada
New York Medical College
🇺🇸
Valhalla, New York, United States
Phoenix Children's Hospital
🇺🇸
Phoenix, Arizona, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸
Detroit, Michigan, United States
Oklahoma University Cancer Institute
🇺🇸
Oklahoma City, Oklahoma, United States
Primary Children's Medical Center
🇺🇸
Salt Lake City, Utah, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital
🇺🇸
Portland, Oregon, United States
Knight Cancer Institute at Oregon Health and Science University
🇺🇸
Portland, Oregon, United States
Centre Hospitalier Universitaire de Quebec
🇨🇦
Quebec, Canada
Children's Hospital of Eastern Ontario
🇨🇦
Ottawa, Ontario, Canada
Cardinal Glennon Children's Hospital
🇺🇸
Saint Louis, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
🇺🇸
Saint Louis, Missouri, United States
Children's Hospital Center for Cancer and Blood Disorders
🇺🇸
Aurora, Colorado, United States
Mayo Clinic Cancer Center
🇺🇸
Rochester, Minnesota, United States
Midwest Children's Cancer Center at Children's Hospital of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸
San Francisco, California, United States
Nemours Children's Clinic
🇺🇸
Jacksonville, Florida, United States
Butterworth Hospital at Spectrum Health
🇺🇸
Grand Rapids, Michigan, United States
Advocate Lutheran General Cancer Care Center
🇺🇸
Park Ridge, Illinois, United States
University of New Mexico Cancer Center
🇺🇸
Albuquerque, New Mexico, United States
CCOP - Kalamazoo
🇺🇸
Kalamazoo, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸
Grosse Pointe Woods, Michigan, United States
Duke Comprehensive Cancer Center
🇺🇸
Durham, North Carolina, United States
Penn State Children's Hospital
🇺🇸
Hershey, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital Comprehensive Cancer Center
🇺🇸
Providence, Rhode Island, United States
Texas Tech University Health Sciences Center School of Medicine - Amarillo
🇺🇸
Amarillo, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸
Dallas, Texas, United States
Covenant Children's Hospital
🇺🇸
Lubbock, Texas, United States
Children's Hospital of The King's Daughters
🇺🇸
Norfolk, Virginia, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸
Green Bay, Wisconsin, United States
Providence Cancer Center at Sacred Heart Medical Center
🇺🇸
Spokane, Washington, United States
Southern California Permanente Medical Group
🇺🇸
Downey, California, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
UAB Comprehensive Cancer Center
🇺🇸
Birmingham, Alabama, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
🇺🇸
Long Beach, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
🇺🇸
Loma Linda, California, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸
Los Angeles, California, United States
Childrens Hospital Los Angeles
🇺🇸
Los Angeles, California, United States
Children's Hospital and Research Center Oakland
🇺🇸
Oakland, California, United States
Children's Hospital of Orange County
🇺🇸
Orange, California, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸
Washington, District of Columbia, United States
Lee Cancer Care of Lee Memorial Health System
🇺🇸
Fort Myers, Florida, United States
Presbyterian - St. Luke's Medical Center
🇺🇸
Denver, Colorado, United States
Connecticut Children's Medical Center
🇺🇸
Hartford, Connecticut, United States
Walter Reed Army Medical Center
🇺🇸
Washington, District of Columbia, United States
Alfred I. duPont Hospital for Children
🇺🇸
Wilmington, Delaware, United States
Memorial Cancer Institute at Memorial Regional Hospital
🇺🇸
Hollywood, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
🇺🇸
Miami, Florida, United States
Miami Children's Hospital
🇺🇸
Miami, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
🇺🇸
Tampa, Florida, United States
All Children's Hospital
🇺🇸
Saint Petersburg, Florida, United States
Kaplan Cancer Center at St. Mary's Medical Center
🇺🇸
West Palm Beach, Florida, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
🇺🇸
Pensacola, Florida, United States
Tod Children's Hospital
🇺🇸
Youngstown, Ohio, United States
St. Christopher's Hospital for Children
🇺🇸
Philadelphia, Pennsylvania, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸
Sioux Falls, South Dakota, United States
Cook Children's Medical Center - Fort Worth
🇺🇸
Fort Worth, Texas, 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
Winthrop University Hospital
🇺🇸
Mineola, New York, United States
Fletcher Allen Health Care - University Health Center Campus
🇺🇸
Burlington, Vermont, United States
Breslin Cancer Center at Ingham Regional Medical Center
🇺🇸
Lansing, Michigan, United States
Methodist Children's Hospital of South Texas
🇺🇸
San Antonio, Texas, United States
Medical University of Ohio Cancer Center
🇺🇸
Toledo, Ohio, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
🇺🇸
Morgantown, West Virginia, United States
Nemours Children's Clinic - Orlando
🇺🇸
Orlando, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
🇺🇸
Orlando, Florida, United States
University of California Davis Cancer Center
🇺🇸
Sacramento, California, United States
Kaiser Permanente Medical Center - Oakland
🇺🇸
Sacramento, California, United States
Kosair Children's Hospital
🇺🇸
Louisville, Kentucky, United States
M.D. Anderson Cancer Center at Orlando
🇺🇸
Orlando, Florida, United States
Children's Mercy Hospital
🇺🇸
Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸
Chapel Hill, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸
Winston-Salem, North Carolina, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸
Charleston, South Carolina, 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
St. Joseph's Hospital and Medical Center
🇺🇸
Paterson, New Jersey, United States
Hopital Sainte Justine
🇨🇦
Montreal, Quebec, Canada
San Jorge Children's Hospital
🇵🇷
Santurce, Puerto Rico
Swiss Pediatric Oncology Group Geneva
🇨🇭
Geneva, Switzerland
Swiss Pediatric Oncology Group Lausanne
🇨🇭
Lausanne, Switzerland
IWK Health Centre
🇨🇦
Halifax, Nova Scotia, Canada
East Tennessee Children's Hospital
🇺🇸
Knoxville, Tennessee, United States
Palmetto Health South Carolina Cancer Center
🇺🇸
Columbia, South Carolina, United States
West Virginia University Health Sciences Center - Charleston
🇺🇸
Charleston, West Virginia, United States
Greenville Hospital Cancer Center
🇺🇸
Greenville, South Carolina, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
🇺🇸
Huntington, West Virginia, United States
Saskatoon Cancer Centre at the University of Saskatchewan
🇨🇦
Saskatoon, Saskatchewan, Canada
Cancer Research Center of Hawaii
🇺🇸
Honolulu, Hawaii, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
🇺🇸
Madison, Wisconsin, United States
Lucille P. Markey Cancer Center at University of Kentucky
🇺🇸
Lexington, Kentucky, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
🇺🇸
Bronx, New York, United States
Dayton Children's - Dayton
🇺🇸
Dayton, Ohio, United States
St. Jude Children's Research Hospital
🇺🇸
Memphis, Tennessee, United States
CCOP - Scott and White Hospital
🇺🇸
Temple, Texas, United States