A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis
- Determine the 1-year local control rate in patients undergoing resection of a solitary
brain metastasis comprising intraoperative radiotherapy using the INTRABEAM® system.
- Determine the survival of patients treated with this therapy.
- Determine distant recurrence of disease in patients treated with this therapy.
- Determine the toxicity of this therapy in these patients.
- Determine the quality of life of patients treated with this therapy.
OUTLINE: This is a nonrandomized study.
Patients undergo surgical resection of a brain metastasis. Patients then undergo
intraoperative radiotherapy using the INTRABEAM® system.
Quality of life is assessed at baseline and then every 3 months for 2 years.
Patients are followed within 48 hours after surgery, at 1 and 3 months, and then every 3
months for 2 years.
PROJECTED ACCRUAL: A total of 31-62 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Local control rate as measured by MRI with contrast at 1 year
Robert Weil, MD
The Cleveland Clinic
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|