The primary purpose of the study is to evaluate the efficacy and safety of temozolomide compared to semustine in the treatment of patients with glioblastoma multiforme or anaplastic astrocytoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
151
Temozolomide orally for 5 consecutive days (Day 1 through Day 5) every 28 days, at a dose of 150 mg/m2/day for subjects previously treated with chemotherapy, or 200 mg/m2/day for subjects who have not received previous chemotherapy.
Semustine orally once every 28 days at a dose of 150 mg/m2/day.
Progression-free survival
Time frame: 2 months, 3 months, and 6 months
Overall survival
Time frame: 6 months
Objective response
Time frame: 6 months
Scoring of health-related quality of life
Time frame: 6 months
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