Skip to main content
. 2012 Oct 17;2012(10):CD006469. doi: 10.1002/14651858.CD006469.pub2

Wallace 1978.

Methods Randomised Phase II trial
September 1974 to June 1976
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
Outcomes OS
PFS
Response rates
Toxicity (WHO)
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