The investigator propose a single-center randomized phase II controlled study designed to compare the management of first recurrence of GBM using etoposide versus tamoxifen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Cross Cancer Institute
Edmonton, Alberta, Canada
RECRUITING3 month progression-free survival
Time between randomization and radiographic or clinical progression leading to change in therapy for recurrent disease or death due to any cause.
Time frame: 3 months
One-year progression-free survival
Time between randomization and radiographic or clinical progression leading to change in therapy for recurrent disease or death due to any cause.
Time frame: 12 months
Overall survival
Time between randomization and death due to any cause. Patients without an event will be censored the last time they were known to be alive.
Time frame: Median, 6-month, 1-year, and 2-year OS rates will be measured
Health-related quality-of-life status
Health-related quality-of-life will be assessed using the EORTC QLQ-BN20 brain tumor module questionnaire. This is a self-report questionnaire consisting of 20 items that assess future uncertainty, visual disorder, motor dysfunction, and communication deficit in brain tumor patients
Time frame: Throughout study completion, up to 5 years.
Adverse events
This includes fatigue, hematologic toxicities (neutropenia, thrombocytopenia, leukopenia, anemia), liver toxicities, hypertension, diarrhea, seizures and thrombosis and will all be recorded.
Time frame: Throughout the whole duration of the trial, up to 5 years
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