Temozolomide Versus Temozolomide + Whole Brain Radiation In Stage IV Melanoma Patients With Asymptomatic Brain Metastases
- Compare the efficacy of temozolomide with or without radiotherapy in terms of overall
survival in patients with stage IV melanoma with asymptomatic brain metastases.
- Compare the time to appearance of neurological symptoms in patients treated with these
- Compare the progression-free survival of patients treated with these regimens.
- Compare the quality of life and quality-adjusted survival of patients treated with
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to LDH
levels (less than 225 U/L vs 225 U/L or more), concurrent metastases (visceral vs soft
tissue), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral temozolomide once daily on days 1-5. Treatment continues
every 4 weeks for a maximum of 1 year in the absence of disease progression or
- Arm II: Patients receive temozolomide as in arm I and whole brain radiotherapy on days
8-12 and 15-19 during the first course of chemotherapy.
Quality of life is assessed before beginning each course and then every 4 weeks after
completion of study drug.
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study within 2 years.
Allocation: Randomized, Primary Purpose: Treatment
Juergen C. Becker, MD, PhD
United States: Federal Government