| Methods |
Study duration: 04/1989 ‐ 12/1996
Type of trial: multicentre RCT, intention‐to‐treat
Number ineligible: 5
Co‐interventions and other potential confounders: 7 clear cell cancer patients randomly allocated to systemic treatment were excluded from analyses |
| Participants |
Stage: II ‐ IV
Residual disease status: < 2cm
Performance status: ECOG < 2
Number randomised: 113
Number evaluable: 100 |
| Interventions |
Arm 1: IV epidox 60 mg/m² + IV CTX 600 mg/m² + IV cisplatin 50 mg/m². Repeated every four weeks for a total of six cycles
Arm 2: IV epidox 60 mg/m² + IV CTX 600 mg/m² + IP cisplatin 50 mg/m². Repeated every four weeks for a total of six cycles |
| Outcomes |
Overall survival
Disease‐free survival
Adverse effects |
| Notes |
Survival = time from randomisation to death (any cause) or Sept 1998 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Multicentre RCT |
| Allocation concealment (selection bias) |
Low risk |
Central allocation |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not described |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
< 20% attrition |
| Selective reporting (reporting bias) |
Low risk |
Analysis by ITT; all expected outcomes reported |
| Other bias |
Low risk |
Methodological quality = high |
