- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01288235
Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation
January 5, 2023 updated by: Torunn Yock, MD, Massachusetts General Hospital
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
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.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 25 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Proton Radiotherapy
|
5 days a week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 years
|
Neurocognitive sequelae
Time Frame: 5 years
|
To describe the incidence and severity of neurocognitive sequelae and correlate with radiation dose delivered to the brain.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control
Time Frame: 5 years
|
To report the 3 year and 5 year local and distant disease control
|
5 years
|
Acute effects
Time Frame: 5 years
|
To assess the acute effects of treatment including hair loss in the portal.
|
5 years
|
Auditory function
Time Frame: 5 years
|
To correlate dose to the cochlea to auditory function.
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Torunn I. Yock, MD, Massachusetts General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2011
Primary Completion (Anticipated)
September 1, 2025
Study Completion (Anticipated)
September 1, 2025
Study Registration Dates
First Submitted
February 1, 2011
First Submitted That Met QC Criteria
February 1, 2011
First Posted (Estimate)
February 2, 2011
Study Record Updates
Last Update Posted (Estimate)
January 9, 2023
Last Update Submitted That Met QC Criteria
January 5, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Brain Neoplasms
- Ependymoma
- Astrocytoma
- Ganglioglioma
Other Study ID Numbers
- 10-206
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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