Temozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer (Study P03247AM3)(COMPLETED) - Tabular View

Tracking Information
First Received Date ^ICMJE	February 4, 2004
Last Updated Date	March 1, 2007
Start Date ^ICMJE	March 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Overall Survival
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00076856 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Time to radiological CNS progression
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Temozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer (Study P03247AM3)(COMPLETED)
Official Title ^ICMJE	A Randomized, Open-Label Phase 2 Study of Temozolomide Added to Whole Brain Radiation Therapy Versus Whole Brain Radiation Therapy Alone for the Treatment of Brain Metastasis From Non-Small Cell Lung Cancer
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 is to demonstrate an improvement in the time to radiological CNS progression with the addition of TMZ to WBRT.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis Brain Neoplasms
Intervention ^ICMJE	Drug: Temozolomide
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	100
Completion Date	November 2007
Primary Completion Date
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00076856
Responsible Party
Study ID Numbers ^ICMJE	P03247
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	March 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP