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. 2017 Aug 29;2017(8):CD004064. doi: 10.1002/14651858.CD004064.pub4

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
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