NCT00076856

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Temozolomide

Timeline

• Start date: 2004-03-31
• Primary completion: 2006-03-31
• Completion: 2006-03-31
• First posted: 2004-02-06
• Last updated: 2017-05-09