Li 2015.
| Methods | "prospectively recruited AGC patients all over China" (did not state number of centres involved) 2 arms: "randomly assigned in a 1:1 ratio to receive S1 plus cisplatin (CS group) or fluorouracil plus cisplatin (CF group)" |
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| Participants | 255 patients screened, 120 received at least one cycle of CS, 116 received at least one cycle of CF Mean age: CS group ‐ 53.3 years, CF group ‐ 55 years "About 50% of the patients had low differentiated cancer. Approximately 85% of the patients had more than one site of metastasis and over half of the patients received previous gastrectomy" |
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| Interventions | "S‐1 was given as 40mg/m2 twice daily on day 1‐21 and cisplatin was 20mg/m2 iv drip on day 1‐4, repeated every 5 weeks in the CS group. In the CF group, 5‐Fu was given as 800 mg/m2/d CI 120h, and the dosage of cisplatin was 20mg/m2 iv on day 1‐4, repeated every 4 weeks" | |
| Outcomes | PFS (although TTP was stated as the primary endpoint, the definition they used is more consistent with PFS) OS Safety |
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| Notes | "As a pilot study, there is no need for sample size calculation. We planned to enroll 270 patients" | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomized grouping information for each patient was generated by central randomization system. At randomization, patients were stratified by ECOG PS (0‐1 vs. 2), numbers of metastasis sites (1 vs. > 1) and gastrectomy (yes vs no)" |
| Allocation concealment (selection bias) | High risk | "Neither patients nor investigators were masked to treatment assignment in this open‐label study" |
| Incomplete outcome data (attrition bias) efficacy | Unclear risk | Low rate of attrition but reasons not specified |
| Incomplete outcome data (attrition bias) safety | Unclear risk | Low rate of attrition but reasons not specified |
| Selective reporting (reporting bias) | Unclear risk | N/A |
| Other bias | High risk | "As a pilot study, there is no need for sample size calculation. We planned to enroll 270 patients" |
| Blinded review of CT/MRI‐scans? | High risk | "Investigators assessed tumor response and progression" |