A Phase II Study of Temozolomide and Radiation Therapy in Patients With Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)
- Determine the intracranial response rate in patients with brain metastasis secondary to
non-small cell lung cancer treated with whole brain radiotherapy and temozolomide.
- Determine the time to radiological progression in patients treated with this regimen.
- Determine the time to neurological progression (confirmed by magnetic resonance imaging
(MRI)) in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients undergo whole brain radiotherapy once daily, 5 days a week, for 2 weeks (10
fractions). Patients also receive concurrent oral temozolomide once daily on days 1-14.
Beginning 3 weeks after the completion of chemoradiotherapy, patients receive oral
temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 6 courses in
the absence of neurologic (Central Nervous System, CNS) progression or unacceptable
Patients were followed every 3 months for 2 years.
ACCRUAL: A total of 26 patients were accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With Intracranial Response
Response was assessed per Response Evaluation Criteria in Solid Tumor (RECIST) by brain MRI in the 21 eligible and treated patients.Complete response (CR): complete disappearance of the clinically detectable malignant brain metastasis(es) being followed on MRI scan off corticosteroids and a stable or improving neurologic exam. Partial response (PR): greater than or equal to a 50% reduction in the sum of the product(s) of the maximal cross-sections on MRI scan with a stable or decreasing dose of corticosteroids and a stable or improving neurologic exam. Response = CR + PR
assessed every cycle while on treatment, then every 3 months for 2 years
H. I. Robins, MD, PhD
University of Wisconsin, Madison
United States: Federal Government