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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00076856 |
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.
Condition | Intervention | Phase |
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Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis Brain Neoplasms |
Drug: Temozolomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Study ID Numbers: | P03247 |
Study First Received: | February 4, 2004 |
Last Updated: | March 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00076856 |
Health Authority: | United States: Food and Drug Administration |
Thoracic Neoplasms Non-small cell lung cancer Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Temozolomide Carcinoma Brain Neoplasms |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasm Metastasis Carcinoma, Non-Small-Cell Lung Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Pharmacologic Actions Neoplasms |
Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents |