NCT01067196
Completed
Not Applicable
A Study of Late Effects After Proton Radiotherapy for Pediatric Tumors of the Brain, Head, and Neck
ConditionsCentral Nervous System Tumors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Central Nervous System Tumors
- Sponsor
- University of Florida
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Measure late effects of proton therapy on pediatric patients with CNS tumors
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to collect information from medical records to see what effects proton beam radiation has on cancer and analyze possible side effects.
Detailed Description
Data collection will be obtained from the patient's medical records including initial evaluation, radiotherapy completion records and follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Estimated \>5 cc of the brain tissue to receive \>5 CGE radiation
- •Patient must be less than 21 years of age at time of consent.
- •Patients that require localized and craniospinal irradiation.
- •Patients and/or patient parent must complete baseline Quality of Life Questionnaire as applicable by patient age group.
Exclusion Criteria
- •Prior radiation therapy.
- •Evidence of metastases outside the central nervous system.
Outcomes
Primary Outcomes
Measure late effects of proton therapy on pediatric patients with CNS tumors
Time Frame: 5.4 years after treatment completion
Secondary Outcomes
- Survival endpoints of local control, progression-free survival, and overall and cause-specific survival.(12 years after treatment completion)
Study Sites (1)
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