A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases
Data relevant to the evaluation the effectiveness of the GliaSite RTS for a resected
dominant brain metastases will be collected. The GliaSite RTS is a radionuclide applicator
and liquid radionuclide (Iotrex) designed to deliver intracavitary radiation therapy for
resected brain tumors. In this case, it will irradiate the resected margins. Brain
metastases not surgically removed will be then treated with radiosurgery
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint of this study is to evaluate the 6 month and 1 year local control rate for 1-3 brain metastases treated with intracavitary radiation therapy.
Data collected at the time of implant, within 72 hours of implant, pre-brachytherapy, brachytherapy, radiosurgery, 1 and 3 months post brachytherapy and every 3 months thereafter
Yes
Allen K Sills, Jr., MD
Principal Investigator
University Hospital
United States: Food and Drug Administration
GS-700
NCT00589212
October 2003
March 2008
Name | Location |
---|---|
Methodist University Hospital | Memphis, Tennessee 38104 |