Cadron 2005.
Methods | Randomised Phase III trial | |
Participants | 24 women with histologically confirmed cervical cancer with distant metastases after surgery or recurrence after radiotherapy | |
Interventions | Arm 1: cisplatin 37.5 mg/m2 iv d1‐2 q28 Arm 2: cisplatin 37.5 mg/m2 iv d1‐2 and Ifosfamide 2 g/m2 iv d1‐2, mesna 0.5 g/m2, 5‐fluorouracil 500 mg/m2 d1‐2, folinic acid 30 mg/m2 d1‐2 q28 |
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Outcomes | Response rates Toxicity (WHO) OS |
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Notes | 3 patients ineligible (did not receive chemotherapy owing to rapid progression). ITT analysis performed. Trial stopped early owing to poor accrual | |
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 | 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 |