| Methods |
Multicentre, prospective, randomised, open‐label, phase III trial |
| Participants |
Histo: 15% Signet ring, 3% Others |
| Interventions |
"Untreated advanced gastric cancer patients randomly received docetaxel and cisplatin at 60 mg/m2 (day 1) followed by fluorouracil at 600 mg/m2/day (days 1–5; mDCF regimen) or cisplatin at 75 mg/m2 (day 1) followed by fluorouracil at 600 mg/m2/day (days 1–5; CF) every 3 weeks" |
| Outcomes |
"The primary end point was progression‐free survival (PFS). The secondary end points were OS, overall response rate (ORR), time‐to‐treatment failure (TTF), and safety" |
| Notes |
NCT00811447 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not stated what method was used. "Random assignment was centralized and stratified for center, liver metastases, prior gastrectomy, Karnofsky performance status (KPS) (80 or above vs below 80), and weight loss during the previous 3 months (5 % or less vs more than 5 %)" |
| Allocation concealment (selection bias) |
Low risk |
Random assignment was centralised |
| Incomplete outcome data (attrition bias)
efficacy |
Low risk |
All patients who received treatment were included in full analysis set |
| Incomplete outcome data (attrition bias)
safety |
Low risk |
All patients who received treatment were included in full analysis set |
| Selective reporting (reporting bias) |
Low risk |
Endpoints were all reported |
| Other bias |
Unclear risk |
N/A |
| Blinded review of CT/MRI‐scans? |
High risk |
"Tumor response and PFS were evaluated by investigators, and although much effort has been done to limit the bias in the evaluation of these parameters..." |
