Ocvirk 2012.
Methods | Single‐centre RCT
2 arms Quality score: D |
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Participants | n = 85 Median age: 55 years Metastatic disease: 85% ECOG 2‐3: 6% |
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Interventions | ECF: epirubicin 50 mg/m² i.v. d 1 + cisplatin 60 mg/m² i.v. d 1 i.v.+ 5‐ FU 200 mg/m²/day continuous infusion d 1‐14, repeated at d 22 ECX: epirubicin 50 mg/m² i.v. d1+ cisplatin 60 mg/m² i.v. d 1 + capecitabine 825 mg/m² orally twice daily d 1‐14, repeated at d 22 Treatment was discontinued in case of disease progression, unacceptable toxicity, or if the patient refused further treatment |
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Outcomes | Overall survival Response rates Time to progression Toxicity |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The method of sequence generation is not described |
Allocation concealment (selection bias) | Low risk | "Randomisation and allocation were done by a registration center" |
Incomplete outcome data (attrition bias) efficacy | Low risk | All randomised patients were included in the ITT analysis |
Incomplete outcome data (attrition bias) safety | Low risk | All randomised patients were included in the ITT analysis |
Selective reporting (reporting bias) | Low risk | N/A ‐ except that TTP rather than PFS reported |
Other bias | High risk | Response assessment was done by abdominal ultrasound and/or abdominal CT (not CT of the thorax and abdomen). Both methods are insufficient. |
Blinded review of CT/MRI‐scans? | High risk | Response assessment was done by abdominal ultrasound and/or abdominal CT (not CT of the thorax and abdomen). Both methods are insufficient. |