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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Temozolomide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No