A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases
- Determine the 6-month and 1-year local control rate in patients with newly diagnosed
supratentorial brain metastases treated with brachytherapy using the intracavity
GliaSite^® Radiation Therapy System (RTS) after surgical resection.
- Determine the overall survival of patients treated with this regimen.
- Determine distant brain recurrence in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Assess the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo surgical resection of the metastatic brain lesion(s) followed by
implantation of the GliaSite^® Radiation Therapy System (RTS). Beginning within the 21 days
after surgical resection, patients undergo brachytherapy using the GliaSite^® RTS over 3-7
days. Patients with tumor(s) remaining after surgery also undergo stereotactic radiosurgery
14-42 days after surgical resection and after completion of brachytherapy. Treatment
continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at 1 and 3 months, and then every 3 months for 2
Patients are followed at 1 and 3 months and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Six-month local control rate
Michael A. Vogelbaum, MD, PhD
The Cleveland Clinic
United States: Federal Government
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|