Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation
Some patients with brain tumors receive standard radiation to help prevent tumor growth. Although standard radiation kills tumor cells, it can also damage normal tissue in the process and lead to more side effects. This research study is looking at a different form of radiation called proton radiotherapy which helps spare normal tissues while delivering radiation to the tumor or tumor bed. Proton techniques irradiate 2-3 times less normal tissue then standard radiation. This therapy has been used in treatment of other cancers and information from those other research studies suggests that this therapy may help better target brain tumors then standard radiation.
Low Grade Glioma
Radiation: Proton radiotherapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation: An Assessment of Long Term Neurocognitive, Neuroendocrine Adn Ototoxicity Outcomes|
- Endocrine dysfunction [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]To describe the incidence of endocrine dysfunction (neuroendocrine and end organ defects) at 3 and 5 years after radiotherapy.
- Neurocognitive sequelae [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]To describe the incidence and severity of neurocognitive sequelae and correlate with radiation dose delivered to the brain.
- Disease control [ Time Frame: 5 years ] [ Designated as safety issue: No ]To report the 3 year and 5 year local and distant disease control
- Acute effects [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]To assess the acute effects of treatment including hair loss in the portal.
- Auditory function [ Time Frame: 5 years ] [ Designated as safety issue: No ]To correlate dose to the cochlea to auditory function.
|Study Start Date:||January 2011|
|Estimated Primary Completion Date:||January 2020 (Final data collection date for primary outcome measure)|
Experimental: Proton Radiotherapy
Radiation: Proton radiotherapy
5 days a week
- Participants will receive proton radiotherapy at the Francis H. Burr Proton Therapy Center which is located at the Massachusetts General Hospital. They will receive the proton radiotherapy 5 days per week. The number of weeks the participant will be receiving proton radiotherapy depends upon the tumor type and location and how well they are tolerating the treatment. Participant's will have a physical exam weekly during proton radiotherapy treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288235
|Contact: Torunn I. Yock, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Torunn Yock, M.D. email@example.com|
|Principal Investigator: Torunn I. Yock, MD|
|Dana-Farber Cancer Institute||Not yet recruiting|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator: Karen Marcus, MD|
|Principal Investigator:||Torunn I. Yock, MD||Massachusetts General Hospital|