| Methods |
Study duration: 06/1986 ‐ 07/1992
Type of trial: Multicentre RCT, intention‐to‐treat basis
Number ineligible: 108 |
| Participants |
Stage III
Residual disease status ≤ 2cm
Performance status: SWOG 0‐2
Number randomised: 654
Number evaluable: 546 |
| Interventions |
Arm 1: IV cyclophosphamide (600 mg/m²) + IV cisplatin (100 mg/m²). Repeated every three weeks for a total of six cycles
Arm 2: IV cyclophosphamide (600 mg/m²) + IP cisplatin (100 mg/m²). Repeated every three weeks for a total of six cycles |
| Outcomes |
Overall survival
Pathological CR
Adverse effects: Anaemia, leukopenia, thrombocytopenia, abdominal pain, fever, tinnitus, hearing loss, neuromuscular effects, pulmonary effects |
| Notes |
Survival = time from randomisation to death (any cause)
Protocol change in Jan 1991, extending accrual for an additional year, to achieve large enough sample ≤ 0.5cm
Methodological quality = high |
| 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 |
Low risk |
Assessor blinding performed |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Low attrition |
| Selective reporting (reporting bias) |
Low risk |
Analysis by ITT; all expected outcomes reported |
| Other bias |
Low risk |
High quality trial |
