Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00253448
Status:
COMPLETED
Last Update Posted:
2011-08-29
First Post:
2005-11-11
Brief Title:
Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Trial of Conventional Radiotherapy With Stereotactic Radiosurgery to High Risk Tumor Regions as Determined by Functional Imaging in Patients With Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2011-08
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 Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue Radiation therapy uses high-energy x-rays to kill tumor cells Giving stereotactic radiosurgery together with radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving stereotactic radiosurgery together with radiation therapy works in treating patients with glioblastoma multiforme
PURPOSE This phase II trial is studying how well giving stereotactic radiosurgery together with radiation therapy works in treating patients with glioblastoma multiforme
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility and efficacy of stereotactic radiosurgery to high-risk tumor regions and conventional radiotherapy in patients with glioblastoma multiforme
Determine overall survival of patients treated with this regimen
Secondary
Determine 6-month progression-free survival of patients treated with this regimen
Determine the absence of tumor growth andor activity on conventional MRMR spectroscopy imaging in patients treated with this regimen
Determine the frequency and severity of RTOG Radiation Therapy Oncology Group CNS toxic effects in patients treated with this regimen
Determine the neurologic function and quality of life of patients treated with this regimen
OUTLINE This is a pilot study
Patients undergo stereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy No more than 2 weeks later patients undergo conventional radiotherapy once daily 5 days a week for 6 weeks
Quality of life is assessed at baseline weekly during radiotherapy at 1 and 3 months after completion of radiotherapy and then every 3 months for 2 years every 6 months for 3 years and annually thereafter
After completion of study treatment patients are followed periodically for at least 5 years
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
Primary
Determine the feasibility and efficacy of stereotactic radiosurgery to high-risk tumor regions and conventional radiotherapy in patients with glioblastoma multiforme
Determine overall survival of patients treated with this regimen
Secondary
Determine 6-month progression-free survival of patients treated with this regimen
Determine the absence of tumor growth andor activity on conventional MRMR spectroscopy imaging in patients treated with this regimen
Determine the frequency and severity of RTOG Radiation Therapy Oncology Group CNS toxic effects in patients treated with this regimen
Determine the neurologic function and quality of life of patients treated with this regimen
OUTLINE This is a pilot study
Patients undergo stereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy No more than 2 weeks later patients undergo conventional radiotherapy once daily 5 days a week for 6 weeks
Quality of life is assessed at baseline weekly during radiotherapy at 1 and 3 months after completion of radiotherapy and then every 3 months for 2 years every 6 months for 3 years and annually thereafter
After completion of study treatment patients are followed periodically for at least 5 years
PROJECTED ACCRUAL A total of 35 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 |
|---|---|---|---|
| CASE-CWRU-1302 | OTHER | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |