Sadighi 2006.
Methods | Single‐centre RCT 2 arms Quality score: D | |
Participants | n=86 Mean age: 56 years Metastatic disease: 100% | |
Interventions | ECF: epirubicin 60 mg/m² + cisplatin 60 mg/m² + 5‐FU 750 mg/m²/day as 5 days continuous infusion; repeated at d 22 for 6 cycles TCF: docetaxel 60 mg/m² + cisplatin 60 mg/m² + 5‐FU 750 mg/m² as 5 days continuous infusion; repeated at d 22 for 6 cycles |
|
Outcomes | Response rate Quality of life Overall survival Progression‐free survival | |
Notes | Extensive analysis of QoL data | |
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 | Unclear risk | No information regarding numbers of patients beside response rates (primary endpoint) |
Incomplete outcome data (attrition bias) safety | High risk | For QoL evaluation, only 71 patients were included in the comparative analysis because 15 patients did not complete the QoL measurements at the beginning of the study |
Selective reporting (reporting bias) | High risk | Missing information regarding PFS as secondary endpoint |
Other bias | Unclear risk | N/A |
Blinded review of CT/MRI‐scans? | Unclear risk | Not stated |