A Phase II Trial of Intensity-Modulated Proton Therapy for Incompletely Resected Craniopharyngioma and Observation for Craniopharyngioma After Radical Resection
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any - 21 |
| Updated: | 10/17/2018 |
| Start Date: | June 22, 2016 |
| End Date: | June 2027 |
| Contact: | Thomas E. Merchant, DO, PhD |
| Email: | referralinfo@stjude.org |
| Phone: | 866-278-5833 |
Craniopharyngioma is a rare brain tumor that affects both children and adults. It arises in a
region of the brain near the pituitary gland, visual pathways, and central blood vessels.
Patients often present with headache, loss of vision or delayed growth. In some instances
they may present with imbalance of water and salts in the body.
The treatment for craniopharyngioma may be radical surgery or a combination of surgery and
radiation therapy. In some instances surgery is not required. If the tumor cannot be
completely removed, radiation therapy may be required. In this study we will use the most
advanced form of proton therapy which is called intensity-modulated proton therapy. This is a
newer form of radiation therapy which has a number of advantages over older forms of proton
therapy and conventional radiation therapy using x-rays.
The main goal of this study is to learn if proton therapy will effectively treat patients
with craniopharyngioma brain tumors and reduce side effects compared to more traditional
forms of radiation therapy.
region of the brain near the pituitary gland, visual pathways, and central blood vessels.
Patients often present with headache, loss of vision or delayed growth. In some instances
they may present with imbalance of water and salts in the body.
The treatment for craniopharyngioma may be radical surgery or a combination of surgery and
radiation therapy. In some instances surgery is not required. If the tumor cannot be
completely removed, radiation therapy may be required. In this study we will use the most
advanced form of proton therapy which is called intensity-modulated proton therapy. This is a
newer form of radiation therapy which has a number of advantages over older forms of proton
therapy and conventional radiation therapy using x-rays.
The main goal of this study is to learn if proton therapy will effectively treat patients
with craniopharyngioma brain tumors and reduce side effects compared to more traditional
forms of radiation therapy.
This study will include participants who are diagnosed or presumed to have craniopharyngioma
based on neuroimaging, intra-operative assessment, or the evaluation of cyst fluid or tissue
after limited or radical surgery. When possible, participants will be enrolled on protocol
prior to surgery.
PRIMARY OBJECTIVE:
- To estimate the distributions of progression-free and overall survival for children and
young adults with craniopharyngioma treated with intensity-modulated proton therapy
while monitoring for excessive central nervous system necrosis, clinically significant
vasculopathy, and permanent neurological conditions or deficits.
SECONDARY OBJECTIVES:
- To estimate the cumulative incidence of cystic intervention and the event-free survival
distribution for children and young adults with craniopharyngioma treated with
intensity-modulated proton therapy; and to compare the distributions of
progression-free, event-free and overall survival with the distributions for the St.
Jude Children's Research Hospital (SJCRH) cohort of patients treated with photon therapy
on which the design of this trial is based.
- To estimate the cumulative incidence of cystic intervention and the distributions of
progression-free survival, overall survival and the event-free 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
proton therapy.
OTHER PRE-SPECIFIED OBJECTIVES:
- To explore potential associations of clinical and treatment factors with the incidence
and severity of neurological, endocrine and cognitive deficits in children and young
adults with craniopharyngioma treated with radical surgery or proton therapy.
Descriptively compare findings for patients treated with proton therapy with the
reported findings for the updated SJCRH cohort treated with photon therapy.
- Using specific measures of sleep quality, excessive daytime sleepiness, daytime
activity, circadian rhythm, fatigue, symptom distresses, and quality of life, explore
associations of sleep, fatigue and quality of life with other measures of central
nervous system (CNS) effects, clinical and treatment factors in children and young
adults with craniopharyngioma treated with radical surgery or proton therapy.
- To evaluate and explore differences in physical performance and movement in children and
young adults with craniopharyngioma treated with radical surgery or proton therapy,
using specific measures of overall physical performance, flexibility, balance,
coordination, muscle strength and power, and cardiopulmonary fitness.
- Estimate and compare the response of residual tumor and the incidence and severity of
structural, functional and vascular effects of normal brain in children and young adults
with craniopharyngioma after treatment with radical surgery or proton therapy using
specific methods of diffusion, contrast-enhancement, vascular and functional
neuroimaging, and explore the association between these and other measures of CNS
effects and clinical and treatment factors.
- Investigate the feasibility of using positron emission tomography (PET) as an in vivo
dose and distal edge verification system for craniopharyngioma patients treated with
proton therapy.
- Measure growth factor and cytokine responses in children and young adults with
craniopharyngioma after treatment with radical surgery or proton therapy, and explore
associations between these and other measures of CNS effects and clinical and treatment
factors. Descriptively compare findings for patients treated with proton therapy with
the reported findings for the updated SJCRH cohort treated with photon therapy.
based on neuroimaging, intra-operative assessment, or the evaluation of cyst fluid or tissue
after limited or radical surgery. When possible, participants will be enrolled on protocol
prior to surgery.
PRIMARY OBJECTIVE:
- To estimate the distributions of progression-free and overall survival for children and
young adults with craniopharyngioma treated with intensity-modulated proton therapy
while monitoring for excessive central nervous system necrosis, clinically significant
vasculopathy, and permanent neurological conditions or deficits.
SECONDARY OBJECTIVES:
- To estimate the cumulative incidence of cystic intervention and the event-free survival
distribution for children and young adults with craniopharyngioma treated with
intensity-modulated proton therapy; and to compare the distributions of
progression-free, event-free and overall survival with the distributions for the St.
Jude Children's Research Hospital (SJCRH) cohort of patients treated with photon therapy
on which the design of this trial is based.
- To estimate the cumulative incidence of cystic intervention and the distributions of
progression-free survival, overall survival and the event-free 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
proton therapy.
OTHER PRE-SPECIFIED OBJECTIVES:
- To explore potential associations of clinical and treatment factors with the incidence
and severity of neurological, endocrine and cognitive deficits in children and young
adults with craniopharyngioma treated with radical surgery or proton therapy.
Descriptively compare findings for patients treated with proton therapy with the
reported findings for the updated SJCRH cohort treated with photon therapy.
- Using specific measures of sleep quality, excessive daytime sleepiness, daytime
activity, circadian rhythm, fatigue, symptom distresses, and quality of life, explore
associations of sleep, fatigue and quality of life with other measures of central
nervous system (CNS) effects, clinical and treatment factors in children and young
adults with craniopharyngioma treated with radical surgery or proton therapy.
- To evaluate and explore differences in physical performance and movement in children and
young adults with craniopharyngioma treated with radical surgery or proton therapy,
using specific measures of overall physical performance, flexibility, balance,
coordination, muscle strength and power, and cardiopulmonary fitness.
- Estimate and compare the response of residual tumor and the incidence and severity of
structural, functional and vascular effects of normal brain in children and young adults
with craniopharyngioma after treatment with radical surgery or proton therapy using
specific methods of diffusion, contrast-enhancement, vascular and functional
neuroimaging, and explore the association between these and other measures of CNS
effects and clinical and treatment factors.
- Investigate the feasibility of using positron emission tomography (PET) as an in vivo
dose and distal edge verification system for craniopharyngioma patients treated with
proton therapy.
- Measure growth factor and cytokine responses in children and young adults with
craniopharyngioma after treatment with radical surgery or proton therapy, and explore
associations between these and other measures of CNS effects and clinical and treatment
factors. Descriptively compare findings for patients treated with proton therapy with
the reported findings for the updated SJCRH cohort treated with photon therapy.
Inclusion Criteria:
- Craniopharyngioma diagnosed by histology, cytology or neuroimaging or intra-operative
assessment
- Patients ages 0-21 years at the time of diagnosis
Exclusion Criteria:
- Prior history of fractionated radiation therapy
- Prior treatment with intracystic P-32 or intracystic bleomycin
- Pregnant females are excluded. Radiation has teratogenic or abortifacient effects
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Thomas E Merchant, DO, PhD
Phone: 866-278-5833
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