Sculier 2002.
Methods | Randomized multi‐center phase III trial Eligible patients
Exclusion criteria
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Participants | CCI arm: 94 participants (ITTpopulation) ‐ 45 participants > 60 years of age CCG arm: 92 participants (ITT population) ‐ 52 participants > 60 years of age IG arm: 94 participants (ITT population) ‐ 46 participants > 60 years of age |
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Interventions | CCI arm: cisplatin 60 mg/m2 over 60‐minute i.v. infusion and carboplatin AUC3 over 30‐minute i.v. infusion and Ifosfamide 4500 mg/m2 over 18‐hour i.v. infusion on day 1, every 4 weeks CCG arm: cisplatin 60 mg/m2 over 60‐minute i.v. infusion on day 1 and carboplatin AUC3 over 30‐minute i.v. infusion on day 1 and gemcitabine 1000 mg/m2 as on days 1, 8, and 15, every 4 weeks IG arm: ifosfamide 4500 mg/m2 over 18‐hour i.v. infusion on day 1 and gemcitabine 1000 mg/m2 on days 1, 8, and 15, every 4 weeks Responding participants given additional courses until best response, disease progression, or major toxicity |
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Outcomes | Primary outcome
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Notes | Despite multiple attempts to contact study authors, no data related to elderly subgroup analysis obtained | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomisation was performed centrally using the minimisation technique and stratified according to centre, Karnofsky PS, presence of brain metastases and prior chest irradiation" |
Allocation concealment (selection bias) | Unclear risk | "Treatment allocation was obtained by calling the ELCWP (European Lung Cancer Working Party) data centre" |
Blinding of outcome assessment (detection bias) OS and 1y OS rate outcome | Unclear risk | No information on blinding |
Blinding of outcome assessment (detection bias) Other outcomes | High risk | No information on blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Four (1.4%) were ineligible for the study (three in the CCG arm and one in the IG arm) for the following reasons: small‐cell lung cancer histology, prior chemotherapy administration, increased bilirubinaemia prior to randomisation, absence of informed consent" |
Selective reporting (reporting bias) | Low risk | No evidence of reporting bias |
Other bias | Unclear risk | No separate elderly subgroup analysis |