Abbreviations and Glossary

Term Definition
aCRC Advanced Colorectal Cancer
AE Adverse Event
ADL Activities of Daily Living
ALP Alkaline Phosphatase (also known as ALKP)
ALT Alanine Transaminase
AR Adverse Reaction
AREG Amphiregulin
APCgene Adenomatous Polyposis Coli Gene
AST Aspartate Transaminase
AZ AstraZeneca
BD or BID Twice Daily

Biomarker defined cohort

The molecular sub-group determined from the biomarker tests performed on the tumour sample sent off at registration. The molecular cohort classification is:

  • BRAF mutation
  • PIK3CA mutation
  • KRAS or NRAS mutations
  • EGFR dependent (wild type for all mutations above)
BRAF v-raf murine sarcoma viral oncogene homolog B1
BSA Body Surface Area
CEA Carcino-embryonic Antigen
CF Consent Form:
  • CF1 = for registration
  • CF2 = for randomisation
  • CF3 = for optional biopsy sub-study
CFI Chemotherapy Free Interval
CI Chief Investigator
CI Confidence Interval
Cohort Molecular Cohort
COIN Continuous chemotherapy plus cetuximab, or Intermittent chemotherapy with standard continuous palliative combination chemotherapy with oxaliplatin and a fluoropyrimidine in first line treatment of metastatic colorectal cancer
COIN-B Intermittent chemotherapy plus continuous or intermittent cetuximab in the first-line treatment of advanced colorectal cancer
CR Complete Response (RECIST)
CRC Colorectal Cancer
CRF Case Report Form
CRN Clinical Research Network
CRP C-Reactive Protein
CR-UK Cancer Research UK
CTA Clinical Trials Authorisation
CTAAC Clinical Trials Awards and Advisory Committee
CTCAE Common Terminology Criteria for Adverse Events
CTIMP Clinical trial of an investigational medicinal product
CTU Clinical Trials Unit
DH Department of Health
DM Data Manager
DMC Data Monitoring Committee
DNA Deoxyribonucleic Acid
DPA (UK) Data Protection Act
DUSP4 & 6 Dual Specific Phosphatases 4 & 6
ECG Electrocardiogram
ECMC Experimental Cancer Medicine Centre
EDTA Ethylene Diamine Tetraacetic Acid
EGFR Epidermal Growth Factor Receptor (also HER-1 and Erb1)
EME Efficacy Mechanism Evaluation
EREG Epiregulin
EU European Union
EudraCT European Union Drug Regulatory Agency Clinical Trial
FBC Full Blood Count
FFPE Formalin Fixed Paraffin Embedded
FOCUS4 The whole FOCUS4 Trials Programme
FOLFIRI 5FU, folinic acid and Irinotecan
FOLFOX 5FU, folinic acid and Oxaliplatin
5FU 5-Fluorouracil
GCP Good Clinical Practice
GFR Glomerular Filtration Rate
GP General Practitioner
GSK GlaxoSmithKine
HER Human Epidermal Growth Factor Receptor (family of EGFR, HER-2, HER-3, HER-4). In non-human species, often termed as Erb-B (1-4) but these are standardised to EGFR and HER (2-4) in the FOCUS4 Protocols
HR Hazard Ratio
IB Investigator Brochure
IBW Ideal Body Weight
ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
IDMC Independent Data Monitoring Committee
IHC Immunohistochemistry
IMP Investigational Medicinal Product
IRAS Integrated Research Application System
ISRCTN International Standard Randomised Controlled Trial Number
IWRS Interactive Web Response System
ITT Intention-to-Treat
LDH Lactate Dehydrogenase
Level Refers to the categorisation of sites into levels 1, 2 or 3
LFTs Liver Function Tests
LLN Lower Limit of Normal
LSA Lack of Sufficient Activity
LVEF Left Ventricular Ejection Fraction
KRAS v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog
m2 Metre-squared
MAMS Multi Arm Multi Stage
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 Trials Programme.
mCRC Metastatic Colorectal Cancer
Mg Magnesium
mg Milligrams
MHRA Medicines and Healthcare products Regulatory Agency
ml Millilitre
mmHg Millimetres of Mercury
MMR Mis-matched Repair
Molecular cohort The molecular sub-group determined from the biomarker tests performed on the tumour sample sent off at registration. The molecular cohort classification  is:
  • BRAF mutation
  • PIK3CA mutation
  • KRAS or NRAS mutations
  • EGFR dependent (wild type for all mutations above)
MRC Medical Research Council
MRC CTU Medical Research Council Clinical Trials Unit
MREC Main Research Ethics Committee
mRNA Messenger Ribonucleic Acid
mSec Millisecond
MTD Maximum Tolerated Dose
MUGA Multi Gated Acquisition Scan
NCI National Cancer Institute
NCRI National Cancer Research Institute
NCRN National Cancer Research Network
NHS National Health Service
NHSCR National Health Service Central Register
NHS-IC National Health Service Information Centre
NIHR National Institute for Health Research
NIHR CSP National Institute for Health Research Co-ordinated System for gaining NHS Permission
NIMP Non-Investigational-Medicinal Product
NRAS Neuroblastoma RAS viral (v-ras) oncogene homolog
ONS Office of National Statistics
OS Overall Survival (an additional potential primary outcome)
OxMdG Oxaliplatin , 5FU and Folinic acid
PALS Patient Advice and Liaison Services
PD Progressive Disease (RECIST)
Period Registration or trial period
PFS Progression-Free Survival (the primary outcome)
PH Proportional Hazards
Phase 2 or 3 Phases of the trial:
Phase 2 includes Stages I and II
Phase 3 includes Stages III and IV
PI Principal Investigator
PIK3CA Phosphatidylinositol-4, 5-bisphosphate 3-kinase, catalytic subunit alpha
PIS Patient Information Sheet:
  • PIS1 = for registration
  • PIS2 = for randomisation
  • PIS3 = for optional biopsy sub-study
PR Partial Response (RECIST)
PS Performance Status
PTEN Phosphatase and Tensin homolog
QA Quality Assurance
QC Quality Control
QL Quality of Life
R&D Research and Development
RCT Randomised Controlled Trial
REC Research Ethics Committee
RECIST Response Evaluation Criteria In Solid Tumors
RGC Research Governance Committee
RGF Research Governance Framework (for Health and Social Care)
SAE Serious Adverse Event
SAP Statistical Analysis Plan
SAR Serious Adverse Reaction
SD Stable Disease (RECIST)
SNP Single-Nucleotide Polymorphism
SOP Standard Operating Procedure
SPC Summary of Product Characteristics
Stage I, II, III or IV Interim analysis stages in the MAMs design
Step 1 or 2 The patient information and consent steps for registration (step 1) and randomisation (step 2)
SUSAR Suspected unexpected serious adverse reaction
TCGA The Cancer Genome Atlas
TGF Transforming Growth Factor
TKI Tyrosine Kinase Inhibitor
TM Trial Manager
TMF Trial Master File
TMG Trial Management Group
Trial Protocol The protocol for a specific trial (letter A onwards)
TSC Trial Steering Committee
UAR Unexpected Adverse Reaction
U&Es Urea and Electrolytes
UKCRN UK Clinical Research Network (now the NIHR CRN)
VEGF Vascular Endothelial Growth Factor
WHO World Health Organization
WT Wild type
XELOX Xeloda (Capecitabine) plus Oxaliplatin