View Clinical Trial (Medical Research Study)
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
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02114 |
| Conditions: |
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Brain Tumor - Low Grade Glioma - Astrocytoma - Ependymoma - Ganglioglioma |
| Purpose: |
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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.
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| Study Summary: |
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- 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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| Criteria: |
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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.
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| NCT ID: |
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NCT01288235 |
| Primary Contact: |
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Principal Investigator
Torunn I. Yock, MD
Massachusetts General Hospital
Torunn I. Yock, MD
Phone: 617-726-5184
Email: tyock@partners.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02114
United States
Torunn Yock, M.D.
Email: tyock@partners.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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