KRGGC 1992.
Methods | Multicentre RCT 2 arms | |
Participants | n = 60 Inoperable or metastatic gastric adenocarcinoma |
|
Interventions | FP: cisplatin 50 mg/m²; 5‐FU 250 mg/m² on day 1; 5‐FU 250 mg/m² days 2‐5 FPEPIR: cisplatin 50 mg/m²; 5‐FU 250 mg/m² days 2‐5; epirubicin 30 mg/m² day 2 |
|
Outcomes | Response rates
Overall survival Toxicity |
|
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Low risk | Sealed envelopes |
Incomplete outcome data (attrition bias) efficacy | High risk | 5 patients not evaluated: 3 death from PD with 4 weeks of treatment, 1 due to relocation, 1 due to absence of follow‐up exam |
Incomplete outcome data (attrition bias) safety | Unclear risk | Toxic reactions classified by "standardization of reporting of results of cancer treatment" grading |
Selective reporting (reporting bias) | Low risk | RR, OS, toxicity (but not CTCAE/WHO) |
Other bias | Unclear risk | N/A |
Blinded review of CT/MRI‐scans? | Unclear risk | Not stated |