MRC Clinical Trials Unit at UCL
90 High Holborn
London
WC1V 6LJ
ICON8 and ICON8B: mrcctu.icon8and8b@ucl.ac.uk
ICON8 Trial Schema and aims
|
First stage: Stage 1A |
Primary outcome measure: Feasibility and Safety in first 50 patients randomised per arm (approximately 150 patients) |
| Stage 1B | Primary outcome measure: Feasibility and Safety in first 50 patients randomised per arm with planned DPS (approximately 150 patients) |
| Second stage: | Primary outcome measure: 9-month Progression Free Survival in first 62 patients randomised per arm (approximately 186 patients) |
| Final stage: | Primary outcome measures: Progression Free Survival and Overall Survival
Secondary outcome measures: Toxicity, Quality of Life and Health Economics |
| Ancillary studies: | Translational Research |
ICON8 and ICON8B