Thigpen 1989.
Methods | Randomised Phase II trial April 1982 to July 1985 |
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Participants | 331 women with advanced or recurrent squamous cell cervical cancer no longer amenable to control by surgery or radiotherapy | |
Interventions | Arm 1: cisplatin 50 mg/m2 iv rate 1 mg/minute q21 days Arm 2: cisplatin 50 mg/m2 iv rate over 24 h q21 days |
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Outcomes | Response rates OS PFS Toxicity |
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Notes | 63 patients deemed ineligible (7 other primary site, 4 second primary, 26 wrong histological subtype, 26 no documentation of cervical primary, 1 elevated blood nitrogen urea at entry, 1 GOG performance status 4 at entry). 6 further patients with unevaluable (1 clerical error at entry, 1 never treated, 1 inadequate pathology, 2 inadequate data submitted, 1 not documented reason for unevaluability) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Latin square arrangement balancing the sequence of assigned regimens within and across institutions |
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 | High risk | 63 patients excluded as ineligible and further 6 patients were unevaluable balanced across groups |
Selective reporting (reporting bias) | Low risk | Published report included all pre‐specified outcomes |
Other bias | Low risk | No hint at any other possible biases |