Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003574
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Radiation Therapy in Treating Patients With Progressive or Recurrent Malignant Brain Tumors
Sponsor:
New Approaches to Brain Tumor Therapy Consortium
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multi-Center Open-Label Clinical Study to Evaluate the Safety and Performance of the Proxima GliaSite RTS a Radiation Delivery System in Patients With Recurrent Malignant Brain Tumors Undergoing Surgical Resection
Status:
COMPLETED
Status Verified Date:
2000-11
Last Known Status:
None
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 Radiation therapy uses high-energy x-rays to damage tumor cells Giving radiation therapy in different ways may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of radiation therapy in treating patients who are undergoing surgical removal of progressive or recurrent malignant brain tumors
PURPOSE Phase II trial to study the effectiveness of radiation therapy in treating patients who are undergoing surgical removal of progressive or recurrent malignant brain tumors
Detailed Description:
OBJECTIVES I Evaluate the safety of the GliaSite RTS in patients with progressive or recurrent malignant brain tumors undergoing surgical resection II Evaluate the performance of the GliaSite RTS in these patients
OUTLINE This is an open label multicenter study Patients undergo surgical resection of the tumor followed by surgical placement of the GliaSite device in the resection cavity One to 2 weeks after surgery patients receive brachytherapy consisting of an infusion of iodine I-125 The I-125 solution is removed and collected 5-7 days later The device is surgically removed within 24 hours Patients are followed at 24 hours 14 days and 1 year post device removal
PROJECTED ACCRUAL Approximately 20-40 patients will be accrued for this study
OUTLINE This is an open label multicenter study Patients undergo surgical resection of the tumor followed by surgical placement of the GliaSite device in the resection cavity One to 2 weeks after surgery patients receive brachytherapy consisting of an infusion of iodine I-125 The I-125 solution is removed and collected 5-7 days later The device is surgically removed within 24 hours Patients are followed at 24 hours 14 days and 1 year post device removal
PROJECTED ACCRUAL Approximately 20-40 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| JHOC-NABTT-9801 | None | None | None |
| NABTT-9801 | None | None | None |