Ethics approval and consent to participate
Cancer
WEST, CANCER
The trial was sponsored by Sheffield Teaching Hospitals NHS Foundation Trust and run by the Cancer Research UK Clinical Trials Unit, University of Birmingham. The protocol and subsequent amendments were approved by the West Midlands–Edgbaston Research Ethics Committee (09/H1208/42) and local institutional review boards in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice Guidelines. Signed informed consent was obtained from all patients before registration. Oversight of the trial was provided by the independent Data Monitoring Committee.