Radiation Therapy in Treating Young Patients With 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.
Central Nervous System Tumor
Radiation: radiation therapy
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas|
- Marginal-failure rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]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.
- Progression-free survival [ Time Frame: Time from study entry to tumor progression or recurrence, with non-tumor-related deaths or events censored ] [ Designated as safety issue: No ]The log rank statistic for comparing life table outcome among subset of patients will be used based on the following prognostic factors: age (3-10 years vs. 11-21 years), prior treatment factors (1 prior chemotherapy, more than 1 prior chemotherapy, and surgery only), location (optic system/hypothalamic vs. hemispheric) and histology (juvenile pilocytic astrocytoma vs. other astrocytoma histologies). Regression model procedures will also be employed to examine issues regarding prognostic factors in this study population.
- Event-free survival [ Time Frame: Minimum time from study entry to tumor disease progression or recurrence, the occurrence of the second malignant neoplasm, or death from any cause ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Time from study entry to death from any cause ] [ Designated as safety issue: No ]
- Quality of life (QOL) of these patients (closed as of 10/27/2010). [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]QOL assessed using the the Behavior Assessment System for Children (BASC), the Adaptive Behavior Assessment System (ABAS), and the Behavior Rating Inventory of Executive Function (BRIEF). and the Symptom Checklist-90-R (SCL-90-R).
- MIB-1 Labeling Index using immunohistochemical techniques with the MIB-1 antibody according to established methods [ Time Frame: At baseline ] [ Designated as safety issue: No ]The MIB-1 Labeling Index will be calculated as the percentage of tumor nuclei that are immunoreactive.
- Correlation MIB-1 Labeling Index with PFS [ Time Frame: From baseline to up to 3 years ] [ Designated as safety issue: No ]The primary methods of analysis will be via stratified Cox regression analysis.
|Study Start Date:||November 2006|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: 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.
Radiation: radiation therapy
Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT
- Determine the marginal-failure rate in young patients with low-grade gliomas treated with reduced-field conformal radiotherapy.
- 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.
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|Study Chair:||Joel M. Cherlow, MD||Todd Cancer Institute at Long Beach Memorial Medical Center|
|Study Chair:||Edward G. Shaw, MD||Comprehensive Cancer Center of Wake Forest University|