A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma or Observation After Radical Resection

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Treatments: Fluorodeoxyglucose F18

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.