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

Thuss‐Patience 2005.

Methods Multicentre RCT
 2 arms
 Quality score: A
Participants n = 90
 Median age: 62.5 years
 Metastatic disease: 98%
 ECOG 2‐3: 3%
Interventions DF: docetaxel 75 mg/m² d 1 + FU 200 mg/m²/day as a 24‐hour continuous infusion d 1‐21, repeated at d 22
 versus
 ECF: epirubicin 50 mg/m² d 1 + cisplatin 60 mg/m² d 1 + FU 200 mg/m²/as a 24‐hour continuous infusion d 1‐21, repeated at d 22
Outcomes Tumour response
 Median survival
 Median time to progression
 Toxicity
Notes Phase II study
The trial was not intended and not statistically powered to perform a head‐to‐head comparison of response rate and toxicity of the 2 treatment arms. ECF serves as an internal control arm to avoid selection bias.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random numbers
Allocation concealment (selection bias) Low risk Central allocation
Incomplete outcome data (attrition bias) 
 efficacy Low risk Analysis of the full analysis set
Incomplete outcome data (attrition bias) 
 safety Low risk Analysis of the full analysis set
Selective reporting (reporting bias) Low risk Report includes all expected outcomes
Other bias High risk The trial was not intended and not statistically powered to perform a head‐to‐head comparison of response rate and toxicity of the 2 treatment arms, ECF serves as an internal control arm to avoid selection bias.
Blinded review of CT/MRI‐scans? Low risk Tumour response was assessed together with an independent radiologist