| Methods |
Multicentre RCT
2 arms
Quality score: D |
| Participants |
n = 118
Median age: 62.5 years
Metastatic disease: 100% |
| Interventions |
XI: capecitabine 1000 mg/m² twice daily d 1‐14 + irinotecan 250 mg/m² d 1, repeated at d 22
versus
XP: capecitabine 1000 mg/m² twice daily d 1‐14 + cisplatin 80 mg/m² d 1, repeated at d 22 |
| Outcomes |
Median overall survival
1‐ and 2‐year rate of OS
Tumour response
Toxicity |
| Notes |
The reported results are from the first stage of the study (design with adaptive interim analysis) |
| 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 |
| Incomplete outcome data (attrition bias)
efficacy |
Low risk |
Analysis of the full‐analysis set of all treated patients with at least one efficacy assessment |
| 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 |
High risk |
Results are from the first stage of the study (design with adaptive interim analysis) |
| Blinded review of CT/MRI‐scans? |
Unclear risk |
Not stated |
