Malkasian 1981.
Methods | Randomised Phase II trial | |
Participants | 41 women with recurrent and metastatic cervical cancer who had had as much surgery as was possible and radiotherapy where appropriate | |
Interventions | Arm 1: 5‐fluorouracil 450 mg/m2 iv d1‐5 and vincristine 1.5 mg/m2 d1 and d5 q35 Arm 2: doxorubicin 60 mg/m2 iv d1 q21 |
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Outcomes | Response rates Toxicity OS Time to treatment failure |
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Notes | 2 patients excluded (1 refused treatment after randomisation, 1 immediately lost to follow‐up). ITT analysis was 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 | 2 patients excluded. No missing outcome data |
Selective reporting (reporting bias) | Low risk | Published report included all pre‐specified outcomes |
Other bias | Low risk | No hint at any other possible biases |