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
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Brain Neoplasms
Both
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Brain Neoplasms
Trial Information
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
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Authority:
United States: Food and Drug Administration
Study ID:
P03247
NCT ID:
NCT00076856
Start Date:
March 2004
Completion Date:
November 2007
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- Neoplasm Metastasis
- Brain Neoplasms
- Brain Neoplasms
- Neoplasms
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Neoplasm Metastasis
- Neoplasms, Second Primary
Name | Location |
|---|
