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

Colucci 1995.

Methods Multicentre RCT
 2 arms
 Quality score: D
Participants n = 71
 Median age: 60 years
Interventions 5‐FU/Lv: Lv 200 mg/m²; 5‐FU 375 mg/m² d 1‐5, repeated at d 22
 versus
 5‐FU/Lv+E: Lv 200 mg/m²; 5‐FU 375 mg/m² d 1‐5, repeated at d 22; epirubicin 60 mg/m² d 1, repeated at d 22
Outcomes Median survival
 Response rates
 Secondary resectability
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated
Allocation concealment (selection bias) Unclear risk Not stated
Incomplete outcome data (attrition bias) 
 efficacy Low risk Reasons for exclusion clearly documented and valid
Incomplete outcome data (attrition bias) 
 safety Low risk Reasons for exclusion clearly documented and valid
Selective reporting (reporting bias) Low risk Report includes all expected outcomes
Other bias Unclear risk No ITT, missing information about type and schedule of follow‐up between groups
Blinded review of CT/MRI‐scans? High risk Not stated, likely unblinded/by investigators