Radiation Therapy in Treating Young Patients With Gliomas
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|ClinicalTrials.gov Identifier: NCT00238264|
Recruitment Status : Completed
First Posted : October 13, 2005
Results First Posted : February 23, 2017
Last Update Posted : August 7, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor Central Nervous System Tumor||Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||December 30, 2013|
|Actual Study Completion Date :||December 31, 2018|
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
- Marginal-failure Rate [ Time Frame: 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.
- Progression-free Survival Probability [ Time Frame: 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 [ Time Frame: 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
- Overall Survival Probability [ Time Frame: 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.
- Quality of Life (QOL) [ Time Frame: 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).
- MIB-1 Labeling Index Using Immunohistochemical Techniques With the MIB-1 Antibody According to Established Methods [ Time Frame: At baseline ]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: Up to 10 years ]The primary methods of analysis will be via stratified Cox regression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238264
|Study Chair:||Joel M. Cherlow, MD||Todd Cancer Institute at Long Beach Memorial Medical Center|
|Study Chair:||Edward G. Shaw, MD||Wake Forest University Health Sciences|