| Methods |
Multicentre RCT
2 arms
Quality score: D |
| Participants |
n = 220
Median age: 64 years
ECOG 2‐3: 9%
Metastatic disease: 94% |
| Interventions |
FLO: oxaliplatin 85 mg/m²; leucovorin 200 mg/m² and FU 2.600 mg/m² as 24‐hour continuous infusion every 14 days
FLP: cisplatin 50 mg/m²; leucovorin 200 mg/m²; FU 2.000 mg/m² weekly for 6 weeks followed by a 2‐week rest |
| Outcomes |
Median overall survival
Tumour response
Toxicity |
| Notes |
A pre‐planned interim analysis of toxicity and response was conducted after 80 patients were included in the study |
| 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 |
ITT analysis of all randomised patients (n = 220) |
| Incomplete outcome data (attrition bias)
safety |
Low risk |
Analysis of all treated patients (n = 214) |
| Selective reporting (reporting bias) |
Unclear risk |
Report includes all expected outcomes (OS, RR and toxicity) |
| Other bias |
High risk |
Differences in baseline distribution of sex (42.9% versus 25% female) and metastatic disease (97.3% versus 90.7%). Preplanned interim analysis. |
| Blinded review of CT/MRI‐scans? |
Unclear risk |
Not stated |
