A Phase III Study of Conventional Radiation Therapy Plus Thalidomide (NSC#66847) Versus Conventional Radiation Therapy for Multiple Brain Metastases
I. Compare the overall survival of patients with multiple brain metastases treated with
radiotherapy with or without thalidomide.
II. Compare the time to tumor progression in patients treated with these regimens.
III. Compare the time to neuro-cognitive progression in patients treated with these
IV. Compare the cause of death distribution in patients treated with these regimens.
V. Compare the frequency of toxic effects of these regimens in these patients. VI. Evaluate
and compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
recursive partitioning analysis class (I vs II) and planned chemotherapy after whole brain
irradiation (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients undergo radiotherapy once daily 5 days a week for 3 weeks. Arm II: Patients
undergo radiotherapy as in arm I. Beginning on the first day of radiotherapy, patients
receive oral thalidomide once daily.
Treatment with thalidomide continues for 2 years in the absence of disease progression or
unacceptable toxicity. Quality of life is assessed at baseline, at completion of
radiotherapy, and then every 2 months for 1 year.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months
for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 332 patients (166 per treatment arm) will be accrued for this
study within 14.5 months.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The log-rank statistic will be used.
Up to 6 years
Radiation Therapy Oncology Group
United States: Food and Drug Administration
|Radiation Therapy Oncology Group||Philadelphia, Pennsylvania 19107|