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Lead
St. Jude Children's Research Hospital
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 therapy using a 5mm clinical target volume margin while monitoring for excessive central nervous system necrosis.
The Secondary Objectives of this study:
* To estimate the cumulative incidence of cystic intervention and the event-free survival distribution for children and young adults with craniopharyngioma treated with limited surgery and proton therapy using a 5mm clinical target volume margin; and compare the distributions of progression-free, event-free and overall survival with the distributions for the St. Jude Children's Research Hospital cohort of 93 patients on which the design of this trial is based.
* To estimate the distributions of progression-free survival and overall survival for children and young adults with craniopharyngioma treated only with primary surgical resection and to compare these distributions with the distributions observed for patients treated with limited surgery and proton therapy.
Age
0–21
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Craniopharyngioma diagnosed by histology, cytology or neuroimaging.
Patients ages 0-21 years at the time of diagnosis.
You may not be 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.
Clareo Health | A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma or Observation After Radical Resection