Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation
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ClinicalTrials.gov Identifier: NCT01288235 |
Recruitment Status
:
Active, not recruiting
First Posted
: February 2, 2011
Last Update Posted
: October 17, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain Tumor Low Grade Glioma Astrocytoma Ependymoma Ganglioglioma | Radiation: Proton radiotherapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | January 2011 |
Estimated Primary Completion Date : | January 2020 |
Estimated Study Completion Date : | January 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Proton Radiotherapy
Proton Radiotherapy
|
Radiation: Proton radiotherapy
5 days a week
|
- Endocrine dysfunction [ Time Frame: 5 years ]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 ]To describe the incidence and severity of neurocognitive sequelae and correlate with radiation dose delivered to the brain.
- Disease control [ Time Frame: 5 years ]To report the 3 year and 5 year local and distant disease control
- Acute effects [ Time Frame: 5 years ]To assess the acute effects of treatment including hair loss in the portal.
- Auditory function [ Time Frame: 5 years ]To correlate dose to the cochlea to auditory function.

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Ages Eligible for Study: | 1 Year to 25 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Biopsy proven low grade glioma or astrocytoma, ependymoma, craniopharyngioma, meningioma, neurocytoma, medulloblastoma or gangliogliomas or other rare tumor requiring tumor bed or tumor irradiation. Patients with a presumed diagnosis of optic glioma or gliomas based on imaging and clinical characteristics will also be allowed on this trial.
- Patients with biopsy proven high grade glioma (excluding GBM) and a gross total resection and patients with non-disseminated atypical teratoid rhabdoid (ATRT) may also be included.
- Pathologic diagnosis must be based on pathology or pathology review by Department of Pathology at MGH or another DF/HCC institution.
- Age between 1-25 years.
- Life expectancy of greater than 1 year.
- ECOG Performance Status 0, 1, 2 or 3 or Lansky performance status 30 or greater.
- Girls and women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
Exclusion Criteria:
- Participants who have had radiotherapy to the site to be treated.
- Participants with known spinal or distant metastases. Patients with ependymoma, medulloblastoma or germinoma must have metastatic workup including spine MRI to rule out metastases.
- Uncontrolled intercurrent illness that would limit compliance with study requirements.
- Pregnant or breastfeeding women.
- Patients who cannot participate in contributing to the neurocognitive outcomes due to severe neurologic impairment or language barrier (ie not English or Spanish speaking) will be excluded from this study.

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): NCT01288235
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Torunn I. Yock, MD | Massachusetts General Hospital |
Responsible Party: | Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01288235 History of Changes |
Other Study ID Numbers: |
10-206 |
First Posted: | February 2, 2011 Key Record Dates |
Last Update Posted: | October 17, 2017 |
Last Verified: | October 2017 |
Keywords provided by Torunn Yock, MD, Massachusetts General Hospital:
proton radiotherapy |
Additional relevant MeSH terms:
Ganglioglioma Brain Neoplasms Astrocytoma Ependymoma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |