Methods | Randomised controlled trial | |
Participants | 85 FIGO (1976) IA-IB Grade 2 and 3 | |
Interventions | Cisplatin 50 mg/m2 × 6 cycles Q 28/7 versus observation | |
Outcomes | DFS 83% versus 64% OS 88% versus 82% Adverse events in adjuvant chemotherapy arm: nausea and vomiting in more than 2/3 of patients; but in severe form in less than 10% of courses; leukopenia and thrombocytopenia in 14% of patients but >= Grade 3 in only 1% of patients; no episodes of febrile infection Adverse events in no adjuvant chemotherapy arm: not reported Median follow-up: 69 months |
|
Notes | Patients with residual disease in both arms | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Based on tables of random numbers |
Allocation concealment (selection bias) | Low risk | Central randomisation by telephone call to co-ordinating centre |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | Deemed ineligible after randomisation: T: 0/41 (0%) C: 2/44 (5%) Did not report whether any further loss to follow-up occurred |
Blinding of outcome assessors (detection bias) | Unclear risk | Not reported |
Selective reporting (reporting bias) | Unclear risk | Intention-to-treat analysis; adverse events in the ‘no adjuvant chemotherapy’ arm were not reported |