Cleveland, Ohio 44195


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.

Study summary:

OBJECTIVES: Primary - Determine the 1-year local control rate in patients undergoing resection of a solitary brain metastasis comprising intraoperative radiotherapy using the INTRABEAM® system. Secondary - 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.


DISEASE CHARACTERISTICS: - Newly diagnosed supratentorial solitary brain metastasis by enhanced MRI or CT scan - Resectable disease - Histological evidence of metastatic carcinoma by intraoperative pathology - No primary lymphoma, germ cell carcinoma, or small cell lung cancer PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - At least 3 months Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Cardiovascular - No uncontrolled hypertension - No unstable angina pectoris - No uncontrolled dysrhythmias Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No serious infection - No other medical illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior temozolomide or polifeprosan 20 with carmustine implant (Gliadel® wafer) for brain metastasis Endocrine therapy - Not specified Radiotherapy - No prior brain radiotherapy of any kind, including local or whole brain external beam radiotherapy, brachytherapy, or stereotactic radiosurgery - No concurrent external beam radiotherapy to the brain - Not planning adjuvant whole brain radiotherapy after study therapy Surgery - Not specified Other - No other prior conventional or investigational local or systemic agents for brain metastasis



Primary Contact:

Study Chair
Robert Weil, MD
The Cleveland Clinic

Backup Contact:


Location Contact:

Cleveland, Ohio 44195
United States

Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente
Phone: 866-223-8100

Site Status: Recruiting

Data Source:

Date Processed: June 25, 2018

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