Wallace 1978.
Methods | Randomised Phase II trial September 1974 to June 1976 |
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Participants | 326 women with advanced, recurrent or persistent squamous cell cervical cancer not suitable for surgery or radiotherapy | |
Interventions | Arm 1: adriamycin 60 mg/m2 iv q21 Arm 2: adriamycin 60 mg/m2 iv, vincristine 1.5 mg/m2 iv q21 Arm 3: adriamycin 60 mg/m2 iv, cyclophosphamide 500 mg/m2 iv q21 |
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Outcomes | OS PFS Response rates Toxicity (WHO) |
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Notes | 65 patients ineligible (more than half for wrong histological subtype, remainder because of wrong primary, 2nd primary, elevated urea or creatinine, poor risk at entry or no evidence of progression after previous treatment; breakdown of numbers not given). Further 69 patients deemed to be not evaluable (inadequate data collection, therapy not initiated, insufficient follow‐up after first course, improper randomisation, clerical errors and others; no specific breakdown in numbers) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not documented |
Allocation concealment (selection bias) | Low risk | Closed envelope technique |
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 | High risk | 65 patients ineligible and further 69 patients deemed to be not evaluable balanced across groups |
Selective reporting (reporting bias) | Low risk | Published report included all pre‐specified outcomes |