Bond 1976.
Methods | Randomised Phase II trial | |
Participants | Number of participants not stated in the paper. Number included in the analysis was 41. Women with histologically confirmed squamous cell carcinoma of the cervix. Most had previously received radical radiotherapy followed by recurrence of local disease, distant metastases or both | |
Interventions | Arm 1: doxorubicin 50 mg iv, vincristine 2 mg iv, methotrexate 50 mg iv all d1 q28 Arm 2: doxorubicin 50 mg iv, vincristine 2 mg iv, methotrexate 50 mg iv, bleomycin 15 mg iv all d1 q28 |
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Outcomes | Toxicity Response rates Median survival |
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Notes | Standard doses of drugs given regardless of height, weight or surface area in order to avoid risk of incorrect dose calculation when treatment administered by junior staff. No ITT analysis | |
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 | Unclear risk | Number of participants not stated in the paper. Number included in the analysis was 41 |
Selective reporting (reporting bias) | Unclear risk | Total number of trial participants not stated only those evaluable |
Other bias | Unclear risk | No comparison of patient characteristics between the 2 groups given |