Mok 2005.
Methods | Randomized phase II trial, conducted at a single center (Department of Clinical Oncology of the Chinese University of Hong Kong) Inclusion criteria
Exclusion criteria
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Participants | GE arm: 45 participants (ITT population) ‐ median age (range): 61 (38 to 70) years/number of elderly not reported CP arm: 44 participants (ITT population) ‐ median age (range): 56 (23 to 72) years/number of elderly 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 etoposide 50 mg/m2 p.o. days 1 through 14, every 4 weeks GP arm: cisplatin 75 mg/m2 over 1‐hour i.v. infusion on day 1 plus gemcitabine 1000 mg/m2 over 30‐minute 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 | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Eligible patients who had signed informed consent were randomly assigned to the GE or the GP arm. Randomization was stratified according to disease stage (stage IIIb vs IV) and was independently performed by a Comprehensive Cancer Trial Unit at the Chinese University of Hong Kong |
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 assessment |
Blinding of outcome assessment (detection bias) Other outcomes | High risk | No information on blinding of assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence of attrition bias |
Selective reporting (reporting bias) | Low risk | No evidence of reporting bias |
Other bias | Unclear risk | No separate elderly subgroup analysis |