Aoyama 2006.
| Methods | Randomized Controlled Study Multi centre Sample size calculation ‐ Power:80% to detect an absolute difference of 30% in median survival time with a 2 sided alpha level of 0.05 ‐ Calculated sample size: 178 patients ‐ Randomized: 132 patients |
|
| Participants | Mean age: 62 % patients with primary breast or lung cancers: 73 % patients with RPA Class 1: 14 % Withdrawals: 0 No. of patients in the Focal therapy plus WBRT arm: 65 No. of patients in the Focal therapy only arm: 67 Baseline Characteristics Comparability: Comparable totally Inclusion criteria ‐ 18 years or older ‐ One to four brain metastases, each with maximum diameter of no more than 3cm on contrast enhanced magnetic resonance imaging scans, derived from a histologically confirmed systemic cancer. ‐ KPS score >=70 Exclusion criteria ‐ Metastases from small cell carcinoma, lymphoma, germinoma and multiple myeloma |
|
| Interventions | Type of Focal intervention: Stereotactic Radiosurgery Dose of WBRT: 30Gy in 10 fractions, EQD22: 37.5Gy Sequence of WBRT: Pre focal intervention Time interval between focal intervention and WBRT: not reported |
|
| Outcomes | Overall survival Local intracranial disease progression Distant intracranial disease progression Neurocognitive function Toxicity |
|
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A permutated blocks randomizations algorithm was used with a block size of 4 |
| Allocation concealment (selection bias) | Low risk | Randomization was performed at the Hokkaido University Hospital Data Center |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
| Selective reporting (reporting bias) | Low risk | All pre‐specified primary and secondary outcomes were reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | The risk of bias from lack of blinding was high for subjective outcomes such as progression free survival, intracranial disease progression, neurocognitive function, health related quality of life and neurological adverse events and low for objective outcomes such as overall survival |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | The risk of bias from lack of blinding was high for subjective outcomes such as progression free survival, intracranial disease progression, neurocognitive function, health related quality of life and neurological adverse events and low for objective outcomes such as overall survival |