| Methods |
Single‐centre RCT
2 arms
Quality score: D |
| Participants |
n = 60
Median age: 56 years
Metastatic disease: 82%
ECOG 2‐3: 17% |
| Interventions |
5‐FU 2600 mg/m² over 24 hours d 1, repeated at d 15
versus
EAP: etoposide 120 mg/m² d 4‐6; adriamycin 20 mg/m² d 1,7; cisplatin 40 mg/m² d 2, 8, repeated at d 29 |
| Outcomes |
Median survival
Time to progression
Response rates
Toxicity |
| Notes |
Study published as abstract, information on final results provided by first author (Popov 2002). Final publication in Medical Oncology 2008. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Method of random numbers |
| Allocation concealment (selection bias) |
Unclear risk |
Not stated |
| Incomplete outcome data (attrition bias)
efficacy |
Low risk |
No excluded patients |
| Incomplete outcome data (attrition bias)
safety |
Low risk |
No excluded patients |
| Selective reporting (reporting bias) |
Low risk |
Report includes all expected outcomes |
| Other bias |
Unclear risk |
N/A |
| Blinded review of CT/MRI‐scans? |
Low risk |
Independent response review was performed by a joint interdisciplinary committee not involved in the study |
