Clinical Trial: Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: 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 Summary:

• 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.

Sponsor: Massachusetts General Hospital

Current Primary Outcome:

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

Original Primary Outcome:

• To estimate the incidence and severity of ototoxicity at three years following the completion of radiation therapy. [ Time Frame: 3 years ]
• To describe the incidence of endocrine dysfunction [ Time Frame: 3 years ]
• To describe the incidence and severity of neurocognitive sequelae overall and in subgroups based on whether or not methotrexate was used as part of the treatment regimen [ Time Frame: 3 years ]

Current Secondary Outcome:

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

Original Secondary Outcome:

• To determine the 3-year progression free survival rate of pediatric medulloblastoma and pineoblastoma patients treated with proton CSI treatment. [ Time Frame: 3 years ]
• To develop a new supine technique to improve the speed of treating patients requiring cranial spinal irradiation and improve the safety of treating patients under anesthesia [ Time Frame: 2 years ]
• To evaluate the acute side effects from CSI using proton beam therapy, including nausea, esophagitis, and weight loss. [ Time Frame: 2 years ]

Information By: Massachusetts General Hospital

Dates:
Date Received: February 3, 2010
Date Started: April 2010
Date Completion: April 2024
Last Updated: March 2, 2017
Last Verified: March 2017