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

Shirao 2013.

Methods Multicentre RCT
 2 arms
 Quality score: B
The study was conducted in Japan .
Participants n = 237
 Median age: 60 years
 Metastatic disease: 100% (all patients had peritoneal metastasis), confirmed by imaging and/or ascites
 ECOG 2‐3: 3.4%
Interventions 5‐FU: 5‐FU 800 mg/m² d 1‐5, repeated at d 29
 versus
 MF: methotrexate 100 mg/m² d 1 + 5‐FU 600 mg/m² d 1 + leucovorin rescue (leucovorin 10 mg/m² x 6) d 1, repeated at d 8
Outcomes Overall survival, ingestion‐possible survival (=surviving days free from nutrition support in patients with sufficient ingestion aat baseline, ingestive improvement in patients without sufficient ingestion at baseline), safety
Notes The study was registered as NCT00149201 and UMIN‐CTR number C000000123.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Minimization
Allocation concealment (selection bias) Low risk Algorithm concealed to investigators
Incomplete outcome data (attrition bias) 
 efficacy Low risk 2 non‐treated patients were excluded in each group.
Incomplete outcome data (attrition bias) 
 safety Low risk 2 non‐treated patients were excluded in each group.
Selective reporting (reporting bias) High risk No response and PFS reported
Other bias High risk Second‐line treatment was given to 80.7% of patients in the 5‐FU group and 72.9 in the MF group, planned interim analysis
Blinded review of CT/MRI‐scans? Unclear risk N/A (no response and PFS reported)