Lu 2014.
Methods | "randomized phase II clinical trial conducted at Guizhou Cancer Hospital, China" | |
Participants | "a total of 94 consecutive patients were enrolled to Guizhou Cancer Hospital and randomly divided into two arms: OXS group (47 cases) and S‐1 group (47 cases)" In both arms, about 3/4 of participants were males Median age was 63 and 65 years in the OXS and S‐1 groups |
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Interventions | "Advanced gastric cancer patients were treated with S‐1 daily for first 2 weeks of a 3‐week cycle, or S‐1 daily for first 2 weeks plus 130 mg/m2 of oxaliplatin administered as a 2‐hour intravenous infusion on day 1 of a 3‐week cycle. S‐1 was orally administered in a fixed quantity according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40 mg two times daily; 1.25,BSA,1.5 m2, 50 mg two times daily; and BSA more than 1.5 m2, 60 mg two times daily" | |
Outcomes | "The primary endpoint was OS, defined as time from date of randomization to date of death from any cause. The secondary endpoints included PFS, RR, and safety profile." | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization was generated using a computer‐generated random sequence concealed in consecutively numbered opaque sealed envelopes" |
Allocation concealment (selection bias) | Low risk | "Randomization was generated using a computer‐generated random sequence concealed in consecutively numbered opaque sealed envelopes" |
Incomplete outcome data (attrition bias) efficacy | Low risk | No patient was lost to follow‐up |
Incomplete outcome data (attrition bias) safety | Low risk | No patient was lost to follow‐up |
Selective reporting (reporting bias) | Unclear risk | OS, PFS, RR and safety included; possible loss of information because of the way the adverse events were categorised and analysed |
Other bias | Unclear risk | N/A |
Blinded review of CT/MRI‐scans? | Unclear risk | Not stated |