As with all clinical trials, there are a set of inclusion and exclusion criteria that patients need to meet before they can be offered entry into the trial. FOCUS4 has two main periods when patients may be offered enrolment:
First, at the start of the registration period when the patient is asked for permission for a sample of their tumour to be sent to a central laboratory for molecular tests. The inclusion and exclusion criteria for this registration period are given below.
Second, when the molecular test results have been returned, the patient is assessed for eligibility for the trial that is most suited to their type of tumour. Currently, there are two trials that will soon be opened (FOCUS4-C and FOCUS4-N) and the inclusion and exclusion criteria are given below.
Inclusion and exclusion criteria for Registration
Inclusion and exclusion criteria for FOCUS4-B
Inclusion and exclusion criteria for FOCUS4-D