Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006259
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2000-09-11
Brief Title:
Stereotactic Radiation Therapy in Treating Patients With Brain Metastases
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Trial of Radiosurgery Alone for Brain Metastases in Elderly Patients or Patients With Poor Performance Status
Status:
COMPLETED
Status Verified Date:
2020-07
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 radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue
PURPOSE Phase II trial to study the effectiveness of stereotactic radiation therapy in treating patients who have brain metastases
PURPOSE Phase II trial to study the effectiveness of stereotactic radiation therapy in treating patients who have brain metastases
Detailed Description:
OBJECTIVES I Determine the efficacy of stereotactic radiosurgery without whole brain radiotherapy in elderly patients or patients with poor performance status who have brain metastases II Determine the neurologic function in these patients after receiving this treatment regimen III Determine the quality of life in these patients with this treatment regimen
OUTLINE Patients undergo stereotactic head frame placement followed by stereotactic radiosurgery using Gamma Knife on day 1 Quality of life is assessed one week prior to and one week after treatment and then at 2 4 6 8 10 and 12 months Patients are followed at one week at 2 4 6 8 10 and 12 months every 4 months for one year and then every 6 months for 3 years
PROJECTED ACCRUAL Approximately 52 patients will be accrued for this study within 2 years
OUTLINE Patients undergo stereotactic head frame placement followed by stereotactic radiosurgery using Gamma Knife on day 1 Quality of life is assessed one week prior to and one week after treatment and then at 2 4 6 8 10 and 12 months Patients are followed at one week at 2 4 6 8 10 and 12 months every 4 months for one year and then every 6 months for 3 years
PROJECTED ACCRUAL Approximately 52 patients will be accrued for this study within 2 years
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