Stereotactic Radiation Therapy in Treating Patients With Brain Metastases
Recruitment status was Recruiting
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
Unspecified Adult Solid Tumor, Protocol Specific
Radiation: stereotactic radiosurgery
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Focal Therapy in the Treatment of Patients With 1-3 Brain Metastases|
- Neurological death rate [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival rate or brain metastases recurrence rate at 6 months [ Designated as safety issue: No ]
- Time to neurological death [ Designated as safety issue: No ]
- Time to systemic death [ Designated as safety issue: No ]
- Karnofsky decay time [ Designated as safety issue: No ]
- Frequency and severity of adverse events [ Designated as safety issue: Yes ]
|Study Start Date:||April 2007|
|Estimated Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
- To determine the neurological death rate following the initiation of conformal stereotactic radiotherapy in patients with 1-3 brain metastases.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00983359
|United States, Ohio|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210-1240|
|Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 firstname.lastname@example.org|
|Principal Investigator:||Mario Ammirati, MD||Ohio State University Comprehensive Cancer Center|