Methods |
Multicentre RCT
2 arms
Quality score: B |
Participants |
n = 77
Metastatic disease: 46%
ECOG 2‐3: 88% |
Interventions |
FA: 5‐FU 270 to 300 mg/m² CI d 1‐ 5; adriamycin 25 mg/m² d 5, repeated at d 22
versus
FAP: 5‐FU 270 to 300 mg/m² CI d 1‐ 5; adriamycin 25 mg/m² d 5; cisplatin 70 mg/m² d 1, repeated at d 22 |
Outcomes |
Median survival
Response rates |
Notes |
Translated from Japanese |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Not stated |
Allocation concealment (selection bias) |
Low risk |
Sequential opaque envelopes |
Incomplete outcome data (attrition bias)
efficacy |
Low risk |
All evaluable pts analysed |
Incomplete outcome data (attrition bias)
safety |
Low risk |
All evaluable pts analysed |
Selective reporting (reporting bias) |
Low risk |
Report includes all expected outcomes |
Other bias |
Unclear risk |
N/A |
Blinded review of CT/MRI‐scans? |
High risk |
Evaluated during group meetings |