General aim

Once phase I trials have determined an appropriate 'therapeutic' dose, the first real evaluation of the treatment's anti-tumour effect comes with the phase II trials (see Box 3.2). The aim here is to assess the activity, feasibility and toxicity of a given dose and schedule and thus to screen out insufficiently active treatments. Individual phase II studies will usually focus on a specific cancer type. This will influence the stage of disease for which a patient is considered suitable for such a study, the outcome measure used to

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