Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor
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|ClinicalTrials.gov Identifier: NCT00107367|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : April 6, 2005
Last Update Posted : January 10, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer||Procedure: conventional surgery Radiation: intraoperative radiation therapy||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis|
|Study Start Date :||April 2004|
|Estimated Primary Completion Date :||April 2010|
- Local control rate as measured by MRI with contrast at 1 year
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107367
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100|
|Study Chair:||Robert Weil, MD||The Cleveland Clinic|