Temozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer (Study P03247)

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Brain Neoplasms

• Registration Number: NCT00076856
• Lead Sponsor: Merck Sharp & Dohme LLC

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

Not available

Study Timeline

• Study First Submitted: 2004-02-04
• Study First Submitted QC: 2004-02-05
• Study First Posted: 2004-02-06
• Study Start: 2004-03-31
• Primary Completion: 2006-03-31
• Study Completion: 2006-03-31
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall Survival

Secondary Outcome Measures

Name	Time	Method
Time to radiological CNS progression