Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01063114|
Recruitment Status : Active, not recruiting
First Posted : February 5, 2010
Last Update Posted : December 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor Medulloblastoma Pineoblastoma||Radiation: proton beam radiation||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: An Assessment of Acute Toxicity and Long Term Neurocognitive, Neuroendocrine and Ototoxicity Outcomes|
|Actual Study Start Date :||April 2010|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
Experimental: Proton Beam Radiation
Proton Beam Radiation
Radiation: proton beam radiation
Given once a day, 5 days a week (Monday-Friday)
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063114
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Torunn I Yock, MD||Massachusetts General Hospital|