Status:
ACTIVE_NOT_RECRUITING
A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma or Observation After Radical Resection
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Craniopharyngioma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief Summary
The goal of this study is to determine the feasibility and safety of treating patients with a brain tumor known as craniopharyngioma with limited surgery and a 5mm clinical target volume margin in com...
Detailed Description
The primary objectives of this study : To estimate the progression-free and overall survival distributions for children and young adults with craniopharyngioma treated with limited surgery and proton...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Craniopharyngioma diagnosed by histology, cytology or neuroimaging.
- Patients ages 0-21 years at the time of diagnosis.
- Exclusion Criteria
- Prior history of fractionated radiation therapy.
- Prior treatment with intracystic P-32, intracystic bleomycin or radiosurgery.
- Pregnant females are excluded. Radiation has teratogenic or abortifacient effects.
Exclusion
Key Trial Info
Start Date :
August 22 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT01419067
Start Date
August 22 2011
End Date
July 1 2026
Last Update
October 17 2025
Active Locations (2)
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1
University of Florida Health Proton Therapy Institute
Jacksonville, Florida, United States, 32206
2
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105