| Methods |
Multicentre RCT
2 arms
Quality score: D |
| Participants |
n = 120
Median age: 62 years
Metastatic disease: 100% |
| Interventions |
ILF: irinotecan 80 mg/m² + LV 500 mg/m² + 5‐FU 2000 mg/m² days 1, 8, 15, 22, 29, 36, repeated at 8 weeks
ELF: etoposide 120 mg/m² + LV 300 mg/m² + 5‐FU 500 mg/m² d 1‐3, repeated at d 22 |
| Outcomes |
Tumour response
Median overall survival
Hazard ratio |
| Notes |
— |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not stated |
| Allocation concealment (selection bias) |
Low risk |
Central allocation by the Co‐ordination Centre for Clinical trials Mainz |
| Incomplete outcome data (attrition bias)
efficacy |
Low risk |
Analysis of the full‐analysis set of all treated patients |
| Incomplete outcome data (attrition bias)
safety |
Low risk |
Analysis of the full‐analysis set of all treated patients |
| Selective reporting (reporting bias) |
Low risk |
Report includes all expected outcomes |
| Other bias |
Low risk |
N/A |
| Blinded review of CT/MRI‐scans? |
Unclear risk |
Not stated |
