Spots Global Cancer Trial Database for Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor

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Trial Identification

Brief Title: Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor

Official Title: A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis

Study ID: NCT00107367

Conditions

Metastatic Cancer

Interventions

conventional surgery

intraoperative radiation therapy

Study Description

Brief Summary: 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.

Detailed Description: 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.