Temozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer
- Registration Number
- PER-003-04
- Lead Sponsor
- SCHERING PLOUGH RESEARCH INSTITUTE,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Age greater than or equal to 18
Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC)
At least one brain metastasis diagnosed within 30 days of randomization
Brain metastases must not have been previously treated with WBRT or radiosurgery
No more than 2 sites of extracranial metastases
May have received prior radiation therapy to the primary tumor and/or systemic metastatic sites
Meets protocol requirements for specified laboratory values.
Written informed consent and cooperation of patient
Appropriate use of effective contraception if of childbearing potential.
Karnofsky Performance Status KPS greater than 70
Score less than 2 on all criteria of the Comprehensive Neurological Outcome Scale (CNOS)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Overall Survival<br>Measure:Overall Survival<br>Timepoints:all the study<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Time to radiological CNS progression<br>Measure:Time to radiological CNS progression<br>Timepoints:all the study<br>