← Back to all trials
Active Not Recruiting
NCT01419067
A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma or Observation After Radical Resection
Conditions: Craniopharyngioma
Sex: All
Ages: N/A – 21 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 112
Sponsor: St. Jude Children's Research Hospital
Location: University of Florida Health Proton Therapy Institute Jacksonville Florida
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 combination with proton therapy. Proton therapy will be indicated for patients with diagnosed craniopharyngioma who are not treated with radical surgery (gross-total resection). Irradiated patients will undergo a series of evaluations designed to evaluate the effects of proton therapy. Similar evaluations will be performed on patients treated with radical surgery. Proton therapy will include 30 treatment fractions administered 5 days per week. Weekly imaging will be a requirement to monitor for cyst expansion and target volume deformation.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT01419067). StuddyBuddy aggregates publicly available trial information.