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Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation

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. Identifier: NCT01288235
Recruitment Status : Active, not recruiting
First Posted : February 2, 2011
Last Update Posted : August 18, 2020
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Torunn Yock, MD, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Brain Tumor Low Grade Glioma Astrocytoma Ependymoma Ganglioglioma Radiation: Proton radiotherapy Phase 2

Detailed Description:
- 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
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 : September 2022
Estimated Study Completion Date : September 2022

Arm Intervention/treatment
Experimental: Proton Radiotherapy
Proton Radiotherapy
Radiation: Proton radiotherapy
5 days a week

Primary Outcome Measures :
  1. 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.

  2. Neurocognitive sequelae [ Time Frame: 5 years ]
    To describe the incidence and severity of neurocognitive sequelae and correlate with radiation dose delivered to the brain.

Secondary Outcome Measures :
  1. Disease control [ Time Frame: 5 years ]
    To report the 3 year and 5 year local and distant disease control

  2. Acute effects [ Time Frame: 5 years ]
    To assess the acute effects of treatment including hair loss in the portal.

  3. Auditory function [ Time Frame: 5 years ]
    To correlate dose to the cochlea to auditory function.

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01288235

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
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Principal Investigator: Torunn I. Yock, MD Massachusetts General Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital Identifier: NCT01288235    
Other Study ID Numbers: 10-206
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Keywords provided by Torunn Yock, MD, Massachusetts General Hospital:
proton radiotherapy
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue