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

Running, not enrolling · Phase 2

Conditions studied: Craniopharyngioma

In brief

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.

Key facts

Study ID

NCT01419067

Run by

St. Jude Children's Research Hospital

People needed

112

Starts

2011-08-22

Expected to finish

2026-07-01

Last updated by the study team

2026-06-17

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Craniopharyngioma diagnosed by histology, cytology or neuroimaging.
• Patients ages 0-21 years at the time of diagnosis.

You may not qualify if…

• 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.

Where it is running

• University of Florida Health Proton Therapy Institute — Jacksonville, Florida, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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