A Phase II Trial of Intensity-Modulated Proton Therapy for Incompletely Resected Craniopharyngioma and Observation for Craniopharyngioma After Radical Resection
Phase 2
Active, not recruiting
- Conditions
- Craniopharyngioma
- Registration Number
- NCT02792582
- Lead Sponsor
- St. Jude Children's Research Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Inclusion Criteria:<br><br> - Craniopharyngioma diagnosed by histology, cytology or neuroimaging or<br> intra-operative assessment<br><br> - Patients ages 0-21 years at the time of diagnosis<br><br>Exclusion Criteria:<br><br> - Prior history of fractionated radiation therapy<br><br> - Prior treatment with intracystic P-32 or intracystic bleomycin<br><br> - Pregnant females are excluded. Radiation has teratogenic or abortifacient effects
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS);Overall survival (OS)
- Secondary Outcome Measures
Name Time Method Compare incidence of first cystic intervention with participants treated with conventional radiation therapy at St. Jude Children's Research Hospital;Compare event-free survival (EFS) with participants treated with conventional radiation therapy at St. Jude Children's Research Hospital;Compare survival distributions with participants treated with conventional radiation therapy at St. Jude Children's Research Hospital;Compare survival distributions between groups