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

Cui 2013.

Study characteristics
Methods Phase II parallel‐group RCT.
Double‐blind study.
Participants Untreated metastatic melanoma harbouring no mutations in KRAS, NRAS, BRAF, or c‐kit genes.
Participants randomised: 114.
Interventions Two‐arm trial:
  • Dacarbazine 250 mg/m² IV daily on days 1 to 5 and endostar 7.5 mg/m² IV daily on days 1 to 14 every 3 weeks up to 12 cycles (N = 57);

  • Dacarbazine 250 mg/m² IV daily on days 1 to 5 (N = 57).

Outcomes Overall survival.
Progression‐free survival.
Tumour response.
Toxicity.
Notes Cross‐over: not reported.
Quality of life: not reported.
Participants with brain metastasis: excluded.
Median follow‐up: not available.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Simple stratified randomization with permuted blocks of size 2 was used to create a prospective randomization schedule".
Comment: Randomisation method was adequate.
Allocation concealment (selection bias) Low risk Quote: "Random assignment of patients was performed by designated personnel at each participating site in a double‐blind fashion such that the investigator and patient did not know the treatment assignment"
Comment: Allocation was likely concealed.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "Double‐blind".
Comment: This method ensured low risk of performance bias.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "Double‐blind".
Comment: This method ensured low risk of detection bias.
Incomplete outcome data (attrition bias)
All outcomes Low risk Missing outcome data were balanced across intervention groups, with similar reasons for missing data across groups.
Selective reporting (reporting bias) Low risk No differences between protocol and published report.
Other bias Low risk The study appeared to be free of other sources of bias.