Feasibility study of resection and GammaTile followed by concomitant external beam radiation therapy (EBRT) and temozolomide (TMZ) and adjuvant TMZ in newly diagnosed glioblastoma (GBM)
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Enrollment
This study is currently enrolling. -
Associated Conditions
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Research Area
Cancer Research -
Location
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Principal Investigator
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Sponsor
GT Medical Technologies, Inc
The purpose of this research study is to evaluate the safety of GammaTile in combination with the Stupp Protocol for the treatment of newly diagnosed Glioblastoma patients. A GammaTile (GT) is an FDA cleared device used to provide radiation therapy following the removal of a brain tumor. GT are small (2cm x 2cm x 0.4cm) collagen squares/tiles that contain sources of radiation that look like grains of rice. Your doctor will place tiles containing the radiation sources in the cavity left after surgically removing your brain tumor. They do not need to be removed as the collagen tiles will be absorbed by your body and the radiation sources can be left in place. The Stupp Protocol includes External Beam Radiation (EBRT) in combination with Temozolomide (TMZ) which is a chemotherapy drug. EBRT uses external beams to deliver radiation to the cavity left after surgical removal of your brain tumor. After the completion of EBRT/TMZ cycle additional treatment with TMZ will continue for 6 months. Use of GammaTile in combination with Stupp Protocol is investigational in this study.
Enrollment Form
This study is currently enrolling.