Status:
COMPLETED
Temozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer (Study P03247)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to demonstrate improvement in overall survival for the combination of whole brain radiation therapy (WBRT) plus temozolomide (TMZ) versus WBRT alone. Secondary objective i...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
March 31 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2006
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00076856
Start Date
March 31 2004
End Date
March 31 2006
Last Update
May 9 2017
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