Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT00107367
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2005-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor
Sponsor:
The Cleveland Clinic
Organization:
Study Overview
Official Title:
A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis
Status:
UNKNOWN
Status Verified Date:
2009-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: