Radiation Therapy in Treating Young Patients With Gliomas

Phase 2

Completed

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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.

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
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UAB Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States