| Methods |
Multicentre RCT
2 arms
Quality score: D |
| Participants |
n = 316
Median age: 56 years |
| Interventions |
XP: capecitabine 1000 mg/m² twice daily d 1–14; cisplatin 80 mg/m² d 1 every 3 weeks
versus
FP: 5‐FU 800 mg/m²/d as continuous infusion d 1–5 every 3 weeks; cisplatin 80 mg/m² d 1 every 3 weeks |
| Outcomes |
Progression‐free‐survival, overall survival
Tumour response
Toxicity |
| Notes |
— |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random permuted block design |
| Allocation concealment (selection bias) |
Unclear risk |
Not stated |
| Incomplete outcome data (attrition bias)
efficacy |
Low risk |
Analysis of ITT population (n = 316) |
| Incomplete outcome data (attrition bias)
safety |
Low risk |
Analysis of all treated patients (n = 311) |
| Selective reporting (reporting bias) |
Low risk |
Report includes all expected outcomes |
| Other bias |
Low risk |
Patients followed up for OS till end of study regardless of withdrawal + ITT vs PP, and unadjusted vs adjusted analyses performed |
| Blinded review of CT/MRI‐scans? |
Low risk |
An independent review committee (IRC) reviewed patients’ radiological images and assessed tumour responses without knowledge of treatment assignment |
