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 : January 9, 2023
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|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 2025|
|Estimated Study Completion Date :||November 2025|
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||3 Years to 25 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
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|
|Responsible Party:||Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital|
|Other Study ID Numbers:||
P01CA021239 ( U.S. NIH Grant/Contract )
|First Posted:||February 5, 2010 Key Record Dates|
|Last Update Posted:||January 9, 2023|
|Last Verified:||January 2023|
proton beam radiation
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue