| Methods |
Study duration: 1990 ‐ 1996
Type of trial: single centre RCT |
| Participants |
Stage: III
Residual disease status: < or > 2cm
Time from surgery to chemotherapy: unclear
Performance status: ECOG < 4
Number randomised: 90
Number evaluable: 90 (46 IV and 44 IP) |
| Interventions |
Arm 1: IV carboplatin 350 mg/m² + IV cyclophosphamide 600 mg/m². Repeated every three to four weeks for a total of six cycles
Arm 2: IP carboplatin 350 mg/m² + IV cyclophosphamide 600 mg/m². Repeated every three to four weeks for a total of six cycles |
| Outcomes |
Overall survival
Disease‐free survival
Adverse effects: Leukopenia, thrombocytopenia, IP administration complications |
| Notes |
No salvage chemotherapy offered to any patient after recurrence
Methodological quality = low |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No details provided |
| Allocation concealment (selection bias) |
Unclear risk |
No details provided |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not described |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Insufficient information for assessment |
| Selective reporting (reporting bias) |
Unclear risk |
Expected outcomes reported; ITT not described |
| Other bias |
Unclear risk |
Low quality trial |
