Box 32 Key roles of a phase II trial

♦ Assess activity

♦ Assess feasibility

♦ Assess toxicity

♦ Screen out inactive treatments assess activity, and the level of activity that the agent needs to demonstrate if it is to be considered potentially useful.

For cytotoxic agents, phase II studies are often carried out in patients with metastatic disease, with tumour response as the activity measure. Wherever possible, standard outcome measures should be used to facilitate comparison across studies; response is often assessed by the 'RECIST' criteria [3], the key features of which are described in Box 3.3.

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