Protocols


FOCUS4 COMMON TERMINOLOGY

A description of terms used commonly throughout the FOCUS4 Protocol

TERM MEANING
FOCUS4 The whole FOCUS4 Trial Programme
Master Protocol The FOCUS4 Master Protocol describes the procedures for patient identification, registration, biomarker testing and initial 16 weeks of standard therapy procedures. It also contains generic information relating to all trials in the FOCUS4 Trial Programme.
FOCUS4-A The name for a specific trial (letter A onwards)
Trial Protocol The protocol for a specific trial (letter A onwards)
Molecular cohort The molecular sub-group determined from the biomarker tests performed on the tumour sample sent off at registration.
The current molecular cohort classification when FOCUS4 opens is:
  • BRAF mutation
  • PIK3CA mutation 
  • KRAS or NRAS mutations
  • EGFR dependent (wild type for all mutations above)
Biomarker defined cohort Same as molecular cohort
Stage I, II, III or IV The interim analysis stages in the MAMS design.
Phase 2 or 3 The phases of the trial:
Phase 2 includes stages I and II
Phase 3 includes stages III and IV
Step 1 or 2 The patient information and consent steps for registration (Step 1) and randomisation (Step 2)
Period Registration or trial period
Level Refers to the categorisation of participating trial sites into levels 1, 2 or 3. Initial treatment for some molecular cohorts may be limited to higher level sites.