| Methods |
Study duration: 01/1988 ‐ 02/1992
Includes data to 15 Sept 1993
Type of trial: Single centre RCT
Number ineligible: 10 (pathology review) + 7 (refused assigned treatment, 4 IP, 3 IV) + 8 (not evaluable) = 25 |
| Participants |
Stage: IIC to IV
Residual disease status: ≤ 1 cm or > 1 cm
Performance status: ECOG 1‐2
Number randomised: 87
Number evaluable: 62 evaluable for survival data, 67 evaluable for toxicity |
| Interventions |
Arm 1: IV cisplatin 100 mg/m² + IV cyclophosphamide 600 mg/m². Repeated every three weeks for a total of six cycles
Arm 2: IP cisplatin 200 mg/m² + IP etoposide 350 mg/m². Repeated every four weeks for a total of six cycles |
| Outcomes |
Overall survival
Disease‐free survival
Adverse effects: leukopenia, GI, neurologic, renal, IP catheter‐related complications |
| Notes |
Survival = time from randomisation to death (any cause) or last follow‐up
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 |
High risk |
> 20% incomplete data for disease‐free survival and response to treatment |
| Selective reporting (reporting bias) |
Unclear risk |
Expected outcomes reported; ITT not described |
| Other bias |
Unclear risk |
More women in the IV group had ECOG performance status of 0 (14 vs 5) |
