Hsu 2008.
Methods | Randomized phase II trial Inclusion criteria
Exclusion criteria
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Participants | GE arm: 43 participants (ITT population) ‐ median age: 62.3 years (33.9 to 78.6)/elderly participants not reported GP arm: 42 participants (ITT population) ‐ median age: 60.9 years (37.6 to 76)/elderly participants not reported |
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Interventions | GE arm: gemcitabine 1000 mg/m2 over 30‐minute i.v. infusion on days 1, 8, and 15 plus epirubicin 70 mg/m2 on day 15 GP arm: gemcitabine 1000 mg/m2 on days 1, 8, and 15 plus cisplatin 100 mg/m2 over 3‐hour i.v. infusion on day 15. Dose of cisplatin reduced to 80 mg/m2 after first 10 participants randomly assigned because of toxicity |
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Outcomes | Primary outcome
Secondary outcomes
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Notes | Despite multiple attempts, we could not contact study authors to retrieve data on the elderly population | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization was performed by an independent statistical office at the clinical trial centre of National Taiwan University Hospital, using a computer‐generated randomisation allocation sequence. The sequence was concealed until the treatment arms were assigned by the statistical office. EligIble patients were randomised in 1:1 ratio to two treatment arms, namely gemcitabine plus conventional‐dose epirubicin (GE) or gemcitabine—cisplatin (GC) arms" |
Allocation concealment (selection bias) | Low risk | Sequence concealed until treatment arms assigned by the statistical office |
Blinding of outcome assessment (detection bias) OS and 1y OS rate outcome | Unclear risk | Open‐label study considered to have unclear impact on mortality outcomes |
Blinding of outcome assessment (detection bias) Other outcomes | High risk | Open‐label study |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One participant refused randomization; 5 participants refused protocol treatment after randomization (1 in GC arm and 4 in GE arm) |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
Other bias | Unclear risk | Study designed for general population; elderly subgroup analysis not planned nor available |