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Radiation Therapy in Treating Young Patients With Gliomas

Phase 2
Completed
Conditions
Brain Tumor
Central 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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Marginal-failure RateUp 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
NameTimeMethod
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 PFSUp to 10 years

The primary methods of analysis will be via stratified Cox regression

Overall Survival Probability3 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 Probability3 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 Probability3 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 MethodsAt 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

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