A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma or Observation After Radical Resection
- Conditions
- Craniopharyngioma
- Interventions
- Procedure: Radical Surgery or Limited SurgeryDevice: Proton TherapyDrug: ^1^8F-fluorodeoxyglucoseDrug: ^1^1C-methionine
- Registration Number
- NCT01419067
- Lead Sponsor
- St. Jude Children's Research Hospital
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 112
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Craniopharyngioma Patients Radical Surgery or Limited Surgery Craniopharyngioma patients will have 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). Patients who have had radical surgery or limited surgery prior to enrollment on this study and have no evidence of tumor will be observed for 5 years. Participants receive \^1\^8F-fluorodeoxyglucose and \^1\^1C-methionine will be given to aid in tumor visualization. Craniopharyngioma Patients ^1^1C-methionine Craniopharyngioma patients will have 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). Patients who have had radical surgery or limited surgery prior to enrollment on this study and have no evidence of tumor will be observed for 5 years. Participants receive \^1\^8F-fluorodeoxyglucose and \^1\^1C-methionine will be given to aid in tumor visualization. Craniopharyngioma Patients Proton Therapy Craniopharyngioma patients will have 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). Patients who have had radical surgery or limited surgery prior to enrollment on this study and have no evidence of tumor will be observed for 5 years. Participants receive \^1\^8F-fluorodeoxyglucose and \^1\^1C-methionine will be given to aid in tumor visualization. Craniopharyngioma Patients ^1^8F-fluorodeoxyglucose Craniopharyngioma patients will have 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). Patients who have had radical surgery or limited surgery prior to enrollment on this study and have no evidence of tumor will be observed for 5 years. Participants receive \^1\^8F-fluorodeoxyglucose and \^1\^1C-methionine will be given to aid in tumor visualization.
- Primary Outcome Measures
Name Time Method Estimate the progression-free and overall survival distributions for children and young adults with craniopharyngioma treated with limited surgery and proton therapy 5 years Reducing the clinical target volume margin to 5mm and using proton therapy, with the goal of reducing side effects from irradiation, will not increase the rate of tumor progression compared to photon therapy with a similar or larger clinical target volume margin.
- Secondary Outcome Measures
Name Time Method 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 5 years This will be improved by models based on clinical and treatment factors and longitudinal measures of CNS effects.
Estimate the distributions of progression-free survival and overall survival for children and young adults with craniopharyngioma treated only with primary surgical resection 5 years This will be improved by models based on clinical and treatment factors and longitudinal measures of CNS effects
Trial Locations
- Locations (2)
University of Florida Health Proton Therapy Institute
🇺🇸Jacksonville, Florida, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States