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Table 1 Trial Outcome Measures

From: Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial

Trials stage

Primary outcome measures

Secondary outcome measures

Pilot phase

Safety*

Feasibility

Activity Stage I

I: Failure-free survival (FFS)†

Overall survival (OS)

  

Toxicity

  

Skeletal related events

Activity Stage II

I: Failure-free survival (FFS)†

Overall survival (OS)

  

Toxicity

  

Skeletal related events

Activity Stage III

I: Failure-free survival (FFS)†

Overall survival (OS)

  

Toxicity

  

Skeletal related events

Efficacy Stage IV

D: Overall survival

Quality of life

  

Cost effectiveness

  

Failure-free survival†

  

Toxicity

  

Skeletal related events

  1. *Based on toxicity
  2. †Including biochemical failure (see protocol)
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Trials

ISSN: 1745-6215