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

Eigentler 2008.

Study characteristics
Methods Phase III parallel‐group RCT.
Open label study.
Multicentre trial.
Participants Particpants with metastasised melanoma after complete metastasectomy.
Randomised participants: 139.
Interventions Two‐arm trial:
  • Vindesine 3 mg/kg IV twice a week the first 26 weeks following 3 mg/m² every 3 weeks for an additional 26 weeks and finally every 4 weeks for the remaining 52 weeks of the treatment period (N = 69);

  • Observation (N = 73).

Outcomes Progression‐free survival.
Overall survival.
Notes Cross‐over: not reported.
Quality of life: evaluation of the quality of life was insufficient because of the low feedback rate of the questionnaires.
Participants with brain metastasis: not reported.
Median follow‐up: 46 months.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "...permuted block (size 12) randomization list"
Comment: Randomisation method was adequate.
Allocation concealment (selection bias) Low risk Risk was likely low because this was a multicentre trial with centralised randomisation.
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 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.