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

May 8, 2017 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall Survival

Secondary Outcome Measures

Outcome Measure
Time to radiological CNS progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2004

Primary Completion (Actual)

March 31, 2006

Study Completion (Actual)

March 31, 2006

Study Registration Dates

First Submitted

February 4, 2004

First Submitted That Met QC Criteria

February 5, 2004

First Posted (Estimate)

February 6, 2004

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P03247

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis Links

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carcinoma, Non-Small-Cell Lung

Clinical Trials on Temozolomide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe