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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00076856 |
Purpose
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 |
|---|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations
More Information
| Study ID Numbers: | P03247 |
| Study First Received: | February 4, 2004 |
| Last Updated: | March 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00076856 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Central Nervous System Neoplasms Brain Diseases Neoplastic Processes Neoplasms by Site Pathologic Processes Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Neoplasm Metastasis Alkylating Agents Nervous System Neoplasms |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Nervous System Diseases Central Nervous System Diseases Temozolomide Pharmacologic Actions Carcinoma Brain Neoplasms Neoplasms Lung Diseases Antineoplastic Agents, Alkylating Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |