Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma

Study Overview
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Brief Summary
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There are two types of external radiation treatments (proton beam and photon beam). As part of the participant's treatment, they will receive radiation to the entire central nervous system (CNS); this is known as craniospinal irradiation (CSI). In the past, photon radiation therapy has been used for CSI. In this study we will be examining the effects of proton beam radiation therapy. Studies have suggested that this kind of radiation can cause less damage to normal tissue than photon radiation therapy. The physical characteristics of proton beam radiation let the doctor safely deliver the amount of radiation delivered to the tumor that is normally delivered through standard therapy but spare more normal tissue in the process.

Detailed Description
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Before beginning radiation therapy, participants will have scans done in order to prepare for the radiation treatment. Doctors will use information gathered from these scans to plan the best way to deliver radiation to the tumor. The following procedures will be performed either before or during the radiotherapy: Hearing exam; neurocognitive exam; blood tests and cerebral spinal fluid test. Not everyone who participates in this study will receive the same amount of proton radiation therapy. The length of time and amount of radiation received will depend upon the condition of the participant's disease. Radiation treatment will be given once a day, 5 days a week (Monday-Friday). The overall treatment course will be approximately 6 weeks.

Official Title
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Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: An Assessment of Acute Toxicity and Long Term Neurocognitive, Neuroendocrine and Ototoxicity Outcomes

Conditions
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Brain Tumor, Medulloblastoma, Pineoblastoma

Intervention / Treatment
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* Radiation: proton beam radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must have undergone biopsy or attempted surgical resection and must have histologically confirmed medulloblastoma or pineoblastoma. Participants may have had a gross total resection, sub-total resection or biopsy only. For patients with no prior chemotherapy, treatment must start within 35 days of definitive surgery or as indicated if enrolled on therapeutic study Age range between 3 and 25 at the time of enrollment Life expectancy of greater than 3 months Blood laboratory values as outlined in the protocol Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation Exclusion Criteria: Patients with more than one previous chemotherapy regimen Patients with recurrent or progressive disease after one or more regimens of pre-radiation chemotherapy Patients with prior radiation therapy Any major uncontrolled or poorly controlled intercurrent illness that would limit compliance with study requirements Pregnant women

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proton Beam Radiation<br>Proton Beam Radiation | Radiation: proton beam radiation<br>* Given once a day, 5 days a week (Monday-Friday)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ototoxicity | Incidence and severity of ototoxicity at three years following the completion of radiation therapy. | 3 years | 
| Endocrine dysfunction | Incidence and severity of endocrine dysfunction at three years following completion of proton radiation therapy. | 3 years | 
| Neurocognitive Effects | Incidence and severity of neurocognitive sequelae overall and in subgroups based on whether or not methotrexate was used as part of the treatment regimen | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | 3-year progression free survival rate of pediatric medulloblastoma and pineoblastoma patients treated with proton CSI treatment. | 3 years | 
| Treatment efficiency | Speed of treating patients requiring cranial spinal irradiation and improve the safety of treating patients under anesthesia | 2 years | 
| Acute toxicity | Frequency and severity of acute side effects from CSI using proton beam therapy, including nausea, esophagitis, and weight loss. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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proton beam radiation