Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation

Status: Recruiting
Phase: Phase 2
Diagnosis: Pediatric Brain Tumor
NCT ID: NCT01288235 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-206

 

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.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital

Overall PI:
Karen Marcus, MD, Brigham and Women's Hospital

Site-responsible Investigators:
Torunn Yock, MD, Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility 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.
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