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) |