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

Yamamura 1998.

Methods Multicentre RCT
 2 arms
 Quality score: C
Participants n = 71
Interventions MTX/5‐FU/THP: methotrexate 50 mg/m², 5‐FU 650 mg/m², pirarubicin 20 mg/m² d 1, repeated at d 15
 versus
 5‐FU: 5‐FU 650 mg/m² d 1, repeated at d 15
Outcomes Median survival
 Toxicity
Notes Study translated from Japanese
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated
Allocation concealment (selection bias) Low risk Centralised. Phone call
Incomplete outcome data (attrition bias) 
 efficacy Low risk 71/74 evaluable
Incomplete outcome data (attrition bias) 
 safety Low risk 71/74 evaluable
Selective reporting (reporting bias) High risk No response rates available
JCOG criteria for toxicity
Other bias Unclear risk Study translated from Japanese
Blinded review of CT/MRI‐scans? Unclear risk N/A

Abbreviations: 
 BSA: body surface area
 BSC: best supportive care
 CI: continuous infusion
 CT: computed tomography
 d: day
 dFUR: 5‐Deoxyfluouridine
 ECOG: Eastern Cooperative Oncology Group
 5‐FU: 5‐Fluorouracil
 FA: folinic acid
 h: hour
 IQR: interquartile range
 ITT: intention‐to‐treat
 i.v.: intravenous
 KI: Karnofsky‐Index
 KPS: Karnofsky performance status
 Lv: leucovorin
 NCI‐CTC: National Cancer Institute Common Toxicity Criteria
 OS: overall survival
 p.o.: per os (orally)
 PFS: progression‐free survival
 QoL: quality of life
 RCT: randomised controlled trial
 RR: response rate
 TTP: time to progression
 UFT: uracil/ftorafur
 w: week
 WHO: World Health Organization

If not stated differently, all drugs were given as intravenous bolus or short infusion (duration max. 2 hours)