Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation

Study Description

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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.

Study Design

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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 :	September 2022
Estimated Study Completion Date :	September 2022

Arms and Interventions

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

Outcome Measures

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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.

Eligibility Criteria

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Ages Eligible for Study:	1 Year to 25 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Locations

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)

Investigators

Principal Investigator:	Torunn I. Yock, MD	Massachusetts General Hospital

More Information

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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
Last Update Posted:	May 4, 2018
Last Verified:	May 2018

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