Bonomi 1985.
Methods | Randomised Phase II trial | |
Participants | 581 women with squamous cell carcinoma of the cervix considered incurable with surgery or radiation | |
Interventions | Arm 1: cisplatin 50 mg/m2 iv q21 Arm 2: cisplatin 100 mg/m2 q21 Arm 3: cisplatin 20 mg/m2 iv daily d1‐5 q21 All arms to a maximum dose of 400 mg/m2 |
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Outcomes | Response rates Toxicity OS PFS |
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Notes | 54 excluded (5 no histological confirmation of tumour, 32 wrong cell type, 3 inadequate renal function, 8 second or wrong primary tumour, 2 inadequate performance status, 4 improper pre‐protocol treatment). There were a further 30 women who could not be evaluated (8 inadequate pathological material, 3 improper randomisation, 2 clerical error, 11 never received cisplatin, 1 removed by investigator, 5 inadequate data). ITT analysis not performed | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not documented |
Allocation concealment (selection bias) | Unclear risk | Not documented |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not documented but OS unlikely to be affected by blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 54 excluded. There were a further 30 women who could not be evaluated. ITT analysis not performed |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | No hint at any other possible biases |