A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis
A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis
RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I/II trial is studying radiation therapy to see how well it works in treating patients who are undergoing surgery to remove a metastatic brain tumor.
OBJECTIVES:
Primary
Secondary
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.
DISEASE CHARACTERISTICS:
Newly diagnosed supratentorial solitary brain metastasis by enhanced MRI or CT scan
No primary lymphoma, germ cell carcinoma, or small cell lung cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other