radiation therapy
RadiationUndergo 3D-CRT Undergo proton radiation therapy Undergo IMRT
Other names: 3-dimensional conformal radiation therapy, intensity-modulated radiation therapy, 3D conformal radiation therapy, 3D-CRT, IMRT
NCT Number: NCT00238264
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.
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Notify Me3 year–20 year
All sexes
Interventional
Phase 2
Royal Children's Hospital, Brisbane, Queensland, Australia
OBJECTIVES:
Primary
Secondary
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT
Other names: 3-dimensional conformal radiation therapy, intensity-modulated radiation therapy, 3D conformal radiation therapy, 3D-CRT, IMRT
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.
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.
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
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.
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).
Time frame: At baseline
The MIB-1 labeling Index will be calculated as the percentage of tumor nuclei that are immunoreactive.
Time frame: Up to 10 years
The primary methods of analysis will be via stratified Cox regression
Children's Oncology Group
Network
A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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