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. 2012 Oct 17;2012(10):CD006469. doi: 10.1002/14651858.CD006469.pub2

Bezwoda 1986.

Methods Randomised Phase II trial
1982 to 1984
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
Outcomes OS
Response rates
Toxicity
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