Katakami 2006.
Methods | Randomized phase II trial Eligibility criteria
Exclusion criteria
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Participants | CD arm: 68 participants (ITT population) – median age (range): 65 (31 to 75)/number of elderly not reported DG arm: 63 participants (ITT population) – median age (range): 61 (40 to 75)/number of elderly nor reported |
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Interventions | DG arm: docetaxel 60 mg/m2 over 1‐hour i.v. infusion on day 1 and gemcitabine 800 mg/m2 over 30‐minute i.v. infusion on days 1 and 8, every 3 weeks CD arm: cisplatin 80 mg/m2 over 1‐hour i.v. infusion and docetaxel 60 mg/m2 over 1‐hour i.v. infusion on day 1, every 3 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 | "Patients were randomly allocated to receive DC or DG stratified by study centre, disease stage (IIIB or IV) and sex" |
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 assessors for OS and 1yOS but study considered to have unclear impact on mortality outcomes |
Blinding of outcome assessment (detection bias) Other outcomes | High risk | No information on blinding of outcome assessors for other outcomes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Two patients in the DG arm did not receive any protocol treatment. One patient suffered from uncontrollable atrial fibrillation, and the investigator decided against this patient receiving protocol treatment. The other patient had a massive hematemesis from a gastric cancer that was discovered after enrolment (second primary). Because two patients were deemed ineligible, 131 patients were evaluated for survival, response, and toxicity" |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
Other bias | Unclear risk | Study was stopped because of toxicity before target population was enrolled. "The planned patient number was 150 (75 in each arm). However, an unexpected high incidence of grade 3 interstitial lung disease (ILD) was identified exclusively in DG arm by the Adverse Event Reporting system. The principal investigator stopped the enrolment into the trial on September 30, 2003. The Safety Committee reviewed the investigator’s report and recommended that the Japan Lung Cancer Cooperative Clinical Study Group terminate the study immediately because of lung injury in the DG arm" No data provided for the elderly subgroup |