Whole Brain Radiotherapy in Combination With Gefitinib (Iressa) or Temozolomide (Temodal) for Brain Metastases From Non-Small Lung Cancer (NSCLC) A Randomized Phase II Trial
- Compare the efficacy of whole-brain radiotherapy combined with either gefitinib or
temozolomide, in terms of overall survival, in patients with non-small cell lung cancer
and brain metastases.
- Compare the tolerability and toxicity of these regimens in these patients.
- Compare the time to neurological disease progression, time to extracranial disease
progression, and time to overall disease progression, in patients treated with these
- Compare adverse events in patients treated with these regimens.
- Compare cognitive function and quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, parallel-group, multicenter study. Patients are
stratified according to extracranial disease (yes vs no), number of brain metastases (1-3 vs
≥ 4), prior chemotherapy (yes vs no), WHO performance status (0-1 vs 2), and participating
center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo whole-brain radiotherapy (WBRT) once daily on days 1-5 and 8-12
and receive oral gefitinib once daily on days 1-28. Gefitinib treatment repeats every
28 days in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo WBRT as in arm I and receive oral temozolomide once daily on
days 1-21. Temozolomide treatment repeats every 28 days in the absence of disease
progression or unacceptable toxicity.
Quality of life is assessed at baseline and on day 1 of courses 2, 3, and 5.
After completion of study therapy, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 30-86 patients (15-43 per treatment arm) will be accrued for
this study within 3 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Gianfranco Pesce, MD
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni