Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-26 @ 8:54 AM
Study NCT ID:
NCT00006259
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2000-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Radiation Therapy in Treating Patients With Brain Metastases
Sponsor:
Case Comprehensive Cancer Center
Organization:
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:
True
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?: