Van Cutsem 2015.
Methods | Prospective, multinational, randomised, phase II study Fifty‐two sites in the USA and 11 countries in Europe screened and randomised patients |
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Participants | The majority (69%) of patients were male; mean age was 59 years | |
Interventions | 3‐arm study: docetaxel/oxaliplatin (TE), docetaxel/oxaliplatin/5‐FU (TEF), and docetaxel/oxaliplatin/capecitabine (TEX) | |
Outcomes | PFS OS ORR Safety |
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Notes | "Tumour response was evaluated every 8 weeks and classified according to best overall response (World Health Organization criteria). Responses were confirmed by two evaluations conducted ≥4 weeks apart" | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not clear what method |
Allocation concealment (selection bias) | Low risk | RandomiSed centrally using an interactive voice response system |
Incomplete outcome data (attrition bias) efficacy | Low risk | "primary efficacy population was the full analysis population (FAP: all randomized and treated patients analysed in the arm to which they were randomized), with supportive analyses conducted using the intent‐to‐treat (ITT: all randomized patients) and per protocol (PP: assessable patients [received study treatment and had ≥1 post‐baseline tumour assessment] without any major protocol violation) populations" |
Incomplete outcome data (attrition bias) safety | Low risk | "primary efficacy population was the full analysis population (FAP: all randomized and treated patients analysed in the arm to which they were randomized), with supportive analyses conducted using the intent‐to‐treat (ITT: all randomized patients) and per protocol (PP: assessable patients [received study treatment and had ≥1 post‐baseline tumour assessment] without any major protocol violation) populations" |
Selective reporting (reporting bias) | Low risk | PFS, OS, ORR, safety |
Other bias | Unclear risk | N/A |
Blinded review of CT/MRI‐scans? | Unclear risk | Not stated |