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. 2018 Feb 6;2018(2):CD011123. doi: 10.1002/14651858.CD011123.pub2

Gorbonova 2000.

Study characteristics
Methods Phase II parallel‐group RCT.
Open label study.
Participants Untreated metastatic melanoma.
Randomised participants: 30.
Interventions Two‐arm study:
  • Cisplatin 100 mg/m² IV on day 3, aranoza 600 mg/m² IV on days 1 to 2 every 4 weeks (N = 14);

  • Cisplatin 100 mg/m² IV on day 3, aranoza 600 mg/m² IV on days 1 to 2, and IFN‐α 3 mIU on days 5, 7, 9, 11, 13, 15, 17, 19 every 4 weeks (N = 14).

Outcomes Tumour response
Notes Cross‐over: not allowed.
Quality of life: not reported.
Participants with brain metastasis: excluded.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk There was insufficient information to permit judgement.
Allocation concealment (selection bias) Unclear risk There was insufficient information to permit judgement.
Blinding of participants and personnel (performance bias)
All outcomes Low risk As an open label study, no blinding of participants or personnel was possible. However, we believe that in this setting (metastatic melanoma), with the treatments tested and outcomes assessed, the knowledge of which intervention was received or administered (rather than the intervention itself), could not affect the outcomes under investigation. Therefore, we judged the risk of performance bias as low.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk There was insufficient information to permit judgement.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk There was insufficient information to permit judgement.
Selective reporting (reporting bias) Unclear risk There was insufficient information to permit judgement.
Other bias Unclear risk There was insufficient information to permit judgement.