Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-02-21 @ 6:44 PM
Study NCT ID:
NCT00983359
Status:
COMPLETED
Last Update Posted:
2017-06-06
First Post:
2009-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stereotactic Radiation Therapy in Treating Patients With Brain Metastases
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Phase II Trial of Focal Therapy in the Treatment of Patients With 1-3 Brain Metastases
Status:
COMPLETED
Status Verified Date:
2017-05
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 send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase II trial is study how well stereotactic radiation therapy works in treating patients with brain metastases
PURPOSE: This phase II trial is study how well stereotactic radiation therapy works in treating patients with brain metastases
Detailed Description:
OBJECTIVES:
Primary
* To determine the neurological death rate following the initiation of conformal stereotactic radiotherapy in patients with 1-3 brain metastases.
Secondary
* To determine the overall survival rate at 6 months.
* To determine the progression-free survival rate or brain metastases recurrence rate at 6 months.
* To determine the time to neurological death, time to systemic death, and Karnofsky decay time.
* To determine the frequency and severity of adverse events associated with conformal stereotactic radiotherapy.
OUTLINE: Patients undergo conformal stereotactic radiotherapy over 5 days to an area including 3 mm around the metastases or the surgical cavity. Patients may receive additional radiotherapy if symptomatic metastases emerge at different sites.
After completion of study treatment, patients are followed up at 1 and 2 months and then every 3 months thereafter.
Primary
* To determine the neurological death rate following the initiation of conformal stereotactic radiotherapy in patients with 1-3 brain metastases.
Secondary
* To determine the overall survival rate at 6 months.
* To determine the progression-free survival rate or brain metastases recurrence rate at 6 months.
* To determine the time to neurological death, time to systemic death, and Karnofsky decay time.
* To determine the frequency and severity of adverse events associated with conformal stereotactic radiotherapy.
OUTLINE: Patients undergo conformal stereotactic radiotherapy over 5 days to an area including 3 mm around the metastases or the surgical cavity. Patients may receive additional radiotherapy if symptomatic metastases emerge at different sites.
After completion of study treatment, patients are followed up at 1 and 2 months and then every 3 months thereafter.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-03139 | REGISTRY | Clinical Trials Reporting Program (CTRP) | View |