Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107367
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2005-04-05
Brief Title:
Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor
Sponsor:
The Cleveland Clinic
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III 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 III 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 III 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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCF-CTSRC-1065 | None | None | None |
| CCF-K992577 | None | None | None |
| CCF-IRB-7003 | None | None | None |
| CCF-510K | None | None | None |