| Methods |
Multicentre RCT
3 arms
Quality score: A |
| Participants |
n = 280
Median age: 62 years
Metastatic disease: 86%
ECOG 2‐3: 17% |
| Interventions |
FU: 5‐FU 800 mg/m² CI d 1‐5, repeated at d 29
versus
FP: 5‐FU 800 mg/m² CI d 1‐5; cisplatin 20 mg/m² d 1‐5, repeated at d 29
versus
UFTM: UFT (uracil/tegafur) 375 mg/m² twice daily p.o., mitomycin 5 mg/m² d 1, repeated at d 8 |
| Outcomes |
Median survival
Response rates
Toxicity |
| Notes |
Full information about second‐line therapy given: 51% of participants in the combination therapy arms and 57% of participants in the single‐agent 5‐FU arm received a second‐line therapy |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Minimisation |
| Allocation concealment (selection bias) |
Low risk |
JCOG data centre |
| Incomplete outcome data (attrition bias)
efficacy |
Low risk |
ITT |
| Incomplete outcome data (attrition bias)
safety |
Low risk |
ITT |
| Selective reporting (reporting bias) |
Low risk |
Report includes all expected outcomes |
| Other bias |
Low risk |
Both combination chemotherapy arms (FP and UFTM) were combined in the analysis. High rates of second‐line therapy. |
| Blinded review of CT/MRI‐scans? |
Unclear risk |
"objective responses confirmed by central review at regular group meetings" |
