Moseley 1976.
Methods | Randomised Phase II trial | |
Participants | 5 women with squamous cell cervical cancer considered to be unsuitable for surgery. These women were part of a larger trial of 35 patients with squamous cell cancer in a variety of primary sites | |
Interventions | Arm 1: CCNU (lomustine) 100‐130 mg/m2 po depending on bone marrow reserves d1 plus bleomycin 0.5 mg/kg im or iv d8, 11, 15, 18, 22, 25, 29, 32, 36, 39 q42 days Arm 2: CCNU 100‐130 mg/m2 po depending on bone marrow reserves d1 plus vinblastine 0.1 mg/kg iv d8, 15 plus methotrexate 0.5 mg/kg iv (maximum 25 mg) d8, 15 plus bleomycin 0.5 mg/kg im or iv d8, 15, 18, 22, 25, 29, 32 q56 days Maximum cumulative dose of bleomycin is 300 mg |
|
Outcomes | Response rates Toxicity |
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Notes | 1 patient dropped out after cycle 1 day 1 treatment (single‐dose CCNU) to have treatment elsewhere and was considered unevaluable. No ITT analysis performed | |
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 |