Methods |
Multicentre RCT
2 arms
Quality score: D |
Participants |
n = 71
Median age: 60 years |
Interventions |
5‐FU/Lv: Lv 200 mg/m²; 5‐FU 375 mg/m² d 1‐5, repeated at d 22
versus
5‐FU/Lv+E: Lv 200 mg/m²; 5‐FU 375 mg/m² d 1‐5, repeated at d 22; epirubicin 60 mg/m² d 1, repeated at d 22 |
Outcomes |
Median survival
Response rates
Secondary resectability |
Notes |
— |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Not stated |
Allocation concealment (selection bias) |
Unclear risk |
Not stated |
Incomplete outcome data (attrition bias)
efficacy |
Low risk |
Reasons for exclusion clearly documented and valid |
Incomplete outcome data (attrition bias)
safety |
Low risk |
Reasons for exclusion clearly documented and valid |
Selective reporting (reporting bias) |
Low risk |
Report includes all expected outcomes |
Other bias |
Unclear risk |
No ITT, missing information about type and schedule of follow‐up between groups |
Blinded review of CT/MRI‐scans? |
High risk |
Not stated, likely unblinded/by investigators |