Outcomes Study of Late Effects After Proton RT for Pediatric Tumors of the Brain, Head, and Neck
Completed
- Conditions
- Central Nervous System Tumors
- Registration Number
- NCT01067196
- Lead Sponsor
- University of Florida
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measure late effects of proton therapy on pediatric patients with CNS tumors 5.4 years after treatment completion
- Secondary Outcome Measures
Name Time Method Survival endpoints of local control, progression-free survival, and overall and cause-specific survival. 12 years after treatment completion
Trial Locations
- Locations (1)
University of Florida Proton Therapy Institute
🇺🇸Jacksonville, Florida, United States