Bezwoda 1986.
Methods | Randomised Phase II trial 1982 to 1984 |
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Participants | 50 women with recurrent or metastatic cervical cancer | |
Interventions | Arm 1: hydroxyurea 1.5 g/m2 po d1‐10, 14‐d rest period then maintenance with 1 g/m2 po d1‐14 q28 Arm 2: cisplatin 20 mg/m2 iv daily d1‐3 and methotrexate 100 mg/m2 iv d3 with leucovorin rescue |
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Outcomes | OS Response rates Toxicity |
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Notes | 3 patients were excluded (refused chemotherapy after randomisation). 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 | Low risk | Not documented but OS unlikely to be affected by blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 patients were excluded |
Selective reporting (reporting bias) | Low risk | Published report included all pre‐specified outcomes |
Other bias | High risk | Hydroxyurea (arm 1) arm stopped early owing to lack of response, only 12 patients randomised to cisplatin + methotrexate arm (arm 2), the remainder entered that arm as only treatment option once the hydroxyurea arm closed. Thus many randomised and trial results not used in meta‐analyses |