MRC Clinical Trials Unit at UCL
Institute of Clinical Trials & Methodology
90 High Holborn
The primary research objectives fall into 3 main categories:
In the interval following standard first-line chemotherapy, do the proposed interventions improve progression-free survival and overall survival compared with placebo in the biomarker-defined cohorts?
FOCUS4 is an adaptive, molecularly stratified trial which aims to improve the efficiency with which new novel agents can be tested in the colorectal cancer setting. Patients will be registered with newly-diagnosed advanced or metastatic disease from colorectal cancer, undertake a centralised molecular analysis of their tumour and be offered entry into the most appropriate trial based on the results of the molecular tests. Some trials will adapt over time and use a Multi-Stage design that analyses the trial data at pre-specified timepoints to determine whether the new agent is having a strong treatment effect.
There are a number of advantages to the FOCUS4 design (see Trial Schema):
In addition to assessment of any clinical benefit from new agents, FOCUS4 also aims to move with the developing field of biomarkers.