Gridelli 2003.
Methods | Randomized phase III open‐label trial Inclusion criteria
Exclusion criteria
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Participants | V arm: 233/median age at baseline: 74 (range 63 to 85) years; 19% ECOG 2 G arm: 233/median age at baseline: 74 (range 70 to 86) years; 18% ECOG 2 GV arm: 232/median age at baseline: 74 (range 69 to 84) years; 20% ECOG 2 > 70% of entire population had ADL score of 6; 50% had IADL score > 75% |
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Interventions | V arm: vinorelbine 30 mg/m2 i.v. infusion on days 1 and 8, every 3 weeks for maximum of 6 cycles G arm: gemcitabine 1200 mg/m2 i.v. infusion on days 1 and 8, every 3 weeks for maximum of 6 cycles GV arm: gemcitabine 1000 mg/m2 i.v. infusion on days 1 and 8 plus vinorelbine 25 mg/m2 i.v. infusion on days 1 and 8, every 3 weeks for maximum of 6 cycles |
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Outcomes | Primary outcome
Secondary outcomes
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Notes | Statistical analysis planned to test whether GV was superior to each single agent separately (estimated 370 events to detect improvement from 27 weeks to 36 weeks on overall survival corresponding to HR 0.75, with 1‐tailed alpha error of 5%, power 0.87) Two geriatric scales (Active Daily Life (ADL) and Intrumental Active Daily Life (IADL)) completed by investigators at baseline and after third and sixth cycles Quality of life assessed by European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire (QLQ‐C30) and Lung Cancer‐Specific Module (QLC‐LC13). Response and toxicity assessed by WHO criteria |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomisation was performed centrally at the Clinical Trials Office National Cancer Institute (Naples, Italy), using a computer‐generated procedure of minimization. Patients were stratified according to institution, ECOG, performance status (0, 1 or 2) and disease stage (IIIB versus IV)" |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not mentioned |
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 | No evidence of attrition bias |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
Other bias | Low risk | No evidence of other bias |