| Methods |
Random allocation, unmasked design |
| Participants |
100; 60 had brain metastases (26 in the treatment arm, 34 controls), and 40 had gliomas (20 in each arm) |
| Interventions |
Treatment group: Phenytoin 15mg/kg oral loading in 3 divided doses, followed by 5mg/kg po qd (n=45). If intolerance, phenobarbital was used instead (n=1). The control group did not receive treatment |
| Outcomes |
For prevention of seizures after start of therapy, phenytoin was not better than placebo in brain metastases (P = 0.6, logrank), and in gliomas (P=0.95, logrank) |
| Notes |
Trial stopped at 100 pts because seizure and survival rates were lower than expected. The investigators had estimated the sample size for a statistical power of 80% to detect a 15% difference between groups. The trial ultimately had a power of 20% to detect a positive difference |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
