Study characteristics |
Methods |
Randomised 2:1, open‐label, non‐comparative, multicentre |
Participants |
106 randomised. First‐line glioblastomas |
Interventions |
Vandetanib + Stupp protocol vs no vandetanib + Stupp protocol |
Outcomes |
OS: 16.6 vs 15.9 months (P = 0.8, HR not available)
PFS: 7.7 vs 6.2 months (HR not available)
PFS12: 0.25 vs 0.39
Toxicities: mostly haematological – 4.3% clots
|
Notes |
Used MacDonald criteria for radiological assessments |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
“patients were randomly assigned 2:1 at registration to receive RT and temozolomide…” |
Allocation concealment (selection bias) |
High risk |
Not concealed. Open‐label trial |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Not concealed. Open‐label trial |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Uncertain |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
13 patients registered but did not proceed to randomisation. |
Selective reporting (reporting bias) |
Low risk |
All prespecified endpoints reported. |
Other bias |
Low risk |
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