Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor
Recruitment status was: Recruiting
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.
Procedure: conventional surgery
Radiation: intraoperative radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis|
- Local control rate as measured by MRI with contrast at 1 year [ Designated as safety issue: No ]
|Study Start Date:||April 2004|
|Estimated Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107367
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Robert Weil, MD||The Cleveland Clinic|