Rijavec 2010.
Methods | Randomized phase II trial Eligible patients
Exclusion criteria not presented |
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Participants | D arm: not informed DG arm: not informed Demographics for study population: 75 randomly assigned, 69 participants (ITT population), median age 75 years (range 70 to 82) |
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Interventions | D arm: docetaxel 35 mg/m2 i.v. infusion on days 1, 8, and 15, every 4 weeks DG arm: docetaxel 35 mg/m2 i.v. infusion and gemcitabine 800 mg/m2 i.v. infusion on days 1, 8, and 15, every 4 weeks |
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Outcomes | Primary outcome
Secondary outcomes
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Notes | Study prematurely stopped because of slow accrual | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information on random sequence generation |
Allocation concealment (selection bias) | Unclear risk | No information on allocation concealment |
Blinding of outcome assessment (detection bias) OS and 1y OS rate outcome | Unclear risk | No information on blinding of outcome assessors. Study considered to have unclear impact on mortality outcomes |
Blinding of outcome assessment (detection bias) Other outcomes | Unclear risk | No information on blinding of assessors for other outcomes |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information for attrition bias analysis |
Selective reporting (reporting bias) | High risk | Results presented in abstract form only. Characteristics of included patients and toxicity partially presented |
Other bias | High risk | Trial was stopped prematurely because of slow accrual |