Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma
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.
Radiation: proton beam radiation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: An Assessment of Acute Toxicity and Long Term Neurocognitive, Neuroendocrine and Ototoxicity Outcomes|
- Ototoxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Incidence and severity of ototoxicity at three years following the completion of radiation therapy.
- Endocrine dysfunction [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Incidence and severity of endocrine dysfunction at three years following completion of proton radiation therapy.
- Neurocognitive Effects [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Incidence and severity of neurocognitive sequelae overall and in subgroups based on whether or not methotrexate was used as part of the treatment regimen
- Progression Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]3-year progression free survival rate of pediatric medulloblastoma and pineoblastoma patients treated with proton CSI treatment.
- Treatment efficiency [ Time Frame: 2 years ] [ Designated as safety issue: No ]Speed of treating patients requiring cranial spinal irradiation and improve the safety of treating patients under anesthesia
- Acute toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Frequency and severity of acute side effects from CSI using proton beam therapy, including nausea, esophagitis, and weight loss.
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||April 2024|
|Estimated Primary Completion Date:||April 2018 (Final data collection date for primary outcome measure)|
Experimental: Proton Beam Radiation
Proton Beam Radiation
Radiation: proton beam radiation
Given once a day, 5 days a week (Monday-Friday)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063114
|Contact: Torunn I Yock, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Torunn I Yock, MD email@example.com|
|Principal Investigator: Torunn I Yock, MD|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Anita Mahajan, M.D. firstname.lastname@example.org|
|Principal Investigator: Anita Mahajan, MD|
|Principal Investigator:||Torunn I Yock, MD||Massachusetts General Hospital|