Radiation Therapy in Treating Young Patients With Gliomas
- Conditions
- Brain TumorCentral Nervous System Tumor
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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 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).
Correlation MIB-1 Labeling Index With PFS Up to 10 years The primary methods of analysis will be via stratified Cox regression
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)
UAB Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
🇺🇸Long Beach, California, United States
Childrens Hospital Los Angeles
🇺🇸Los Angeles, 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
Children's Hospital Central California
🇺🇸Madera, California, United States
Scroll for more (135 remaining)UAB Comprehensive Cancer Center🇺🇸Birmingham, Alabama, United States