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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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT01419067). StuddyBuddy aggregates publicly available trial information.