Ling 2018.
| Study characteristics | ||
| Methods | Single‐centre RCT Study enrolment commenced 1st January 2010 and follow‐up ended 26th September 2015 |
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| Participants | Disease: advanced GC confirmed by oesophago‐gastro‐duodenoscopy or post‐surgical pathology, including those inoperable or relapsed/metastasis after surgery Previous treatment status: disease progression after DCF chemotherapy Number of participants: 107 enrolled between 1st January 2010 and 1st June 2013 Median age: 53 (31 to 71) years Number of male participants: 70 ECOG PS status: 81 PS0‐1 and 26 PS2 Extent of disease: 46 locally advanced and 61 metastatic Study locations: single centre in China Other relevant key eligibility criteria were: adequate routine bloods including liver and kidney function; normal ECG |
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| Interventions | Arm A (56 participants): intravenous epirubicin 50 mg/m² on Day 1, intravenous oxaliplatin 85 mg/m² on Day 1 and oral capecitabine 625 mg/m² twice daily D1‐14 of 21‐day cycle Arm B (51 participants): intravenous irinotecan 180 mg/m² on Day 1, intravenous leucovorin 400 mg/m² on Day 1, intravenous 5‐FU, 400mg/m² on Day 1 over 24 hours of 14‐day cycle |
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| Outcomes | Endpoints: RR, DCR, safety, PFS, OS | |
| Notes | Text in Chinese. No HR was reported. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was performed using a digit randomisation table |
| Allocation concealment (selection bias) | Unclear risk | Unable to assess on the published full text |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Unable to assess on the published full text |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unable to assess on the published full text |
| Imbalance in baseline characteristics across arms (confounding) | Low risk | The baseline characteristics of patients in the different groups were similar with regard to age, sex ratio, ECOG PS, surgical history, disease stage, histological subtype, and number of metastatic organs. |
| Incomplete outcome data (attrition bias) for outcomes other than QoL | Low risk | Efficacy analyses were performed on intention‐to‐treat population (all the randomised participants) |
| Incomplete outcome data (attrition bias) for QoL outcome | Low risk | Not relevant |
| Selective reporting (reporting bias) | Low risk | No protocol was available, however, all important outcomes were reported |
| Other bias | Low risk | No obvious potential source of bias |