1. SWAG SSG Upper GI Cancer Meeting
Clinical Research Network
West of England
SWAG SSG Upper GI Cancer Meeting
Friday 24 February 2017
Research Report

2. Clinical Research Network & Cancer Services
West ofEngland
SWAG - Somerset Wiltsire Avon & Gloucestershire
South West Children’s Cancer & Leukaemia
Research Network

3. NIHR CRN High Level Objectives
Increase number of participants into NIHR CRN portfolio studies
650,000 in England
21,905 in West of England
Increase the number of studies that deliver to time and target
Target 80%
Increase number of commercial studies delivered through network
Reduce NHS study set up times
Reduce time taken to recruit first participant

4. NIHR CRN Objectives for cancer
Recruit 20% of cancer incidence
West of England = 1,909
Recruit 7.5% of cancer incidence into interventional studies
West of England = 716
Include challenging studies
Cancer surgery – 4 recruits per 100,000 population
Radiotherapy – 6 recruits per 100,000 population
Rare cancers (<6 per 100,000) – 12 recruits per 100,000 population
Children & young people – 3 per 100,000 population
Teenagers & young adults – record number of year olds participating in research

9. Cancer specialty objective for 2017-18
Recruitment into at least 8 of the 13 Cancer subspecialties by either improving recruitment by 10% from 2016/17 or meeting the following recruitment targets per 100,000 population served: 
a) Neuro: Lung: 4
b) Breast: Sarcoma: 0.1
c) Colorectal: Skin: 0.2
d) Paediatrics: Urology: 8
e) Gynae: Head & Neck: 1
g) Haematology: Upper GI: 3
k) Supportive & Palliative Care and Psychosocial Oncology & Survivorship: 3

10. 2016/17 Q1-3 performance against 2017/18 Cancer specialty target

11. Open studies – Upper GI Cancer
16 Upper GI Cancer Studies are currently open across 7 Acute Trusts in the SWAG region.
70% of study sites are either meeting Recruitment to Time and Target (RTT) or only a short way behind with 2 studies yet to recruit:
-PLATFORM in Weston and Yeovil
-ACELARATE: Acelarin first line randomised pancreatic study in Weston and Yeovil
Sub-topic
Studies Open in SWAG
Adjuvant
Neo-AEGIS – UH Bristol
Add-Aspirin – 7 acute trusts in region
Advanced disease – 1st line
ROCS – UH Bristol, Weston, Taunton
GO2 – 7 acute trusts in region
ACELARATE – Weston, in set-up at UH Bristol
Advanced disease – 2nd line
ABC 06 – Swindon, UHBristol, North Bristol
EUROPAC 2 – UHBristol
Locally Advanced
SCALOP-2 - UHBristol
Neo-Adjuvant
ROMIO – UHBristol
Non-interventional/translational
PLATFORM – 6 acute trusts in region
RTL-Advanced - Taunton
Pre-Malignant
RECaD - Gloucestershire
Surgery
BIG ROMIO – UHBristol, Bath
ESPAC-4 – Gloucestershire, Swindon, UHBristol

12. Studies in set up – Upper GI Cancer
Portfolio ID
Study Title
Project type
Trust
Principal Investigator
20358
SCOPE 2: A randomised Phase II/III trial to study radiotherapy dose escalation in patients with oesophageal cancer treated with definitive chemoradiation with an embedded Phase II trial for patients with a poor early response using positron emission tomography (PET)
Non-commercial
Gloucestershire Hospitals
Dr Charlie Candish
16201
ESPAC-5F - European Study Group for Pancreatic Cancer - Trial 5F: Four arm, prospective, multicentre, randomised feasibility trial of immediate surgery compared with neoadjuvant chemotherapies and neoadjuvant chemoradiotherapy.
University Hospitals Bristol
19200
ACELARATE : A Phase III, open label, multicentre randomised clinical study comparing Acelarin (NUC1031) with Gemcitabine in patient with metastatic pancreatic carcinoma
 Dr Stephen Falk
19224
ACTICCA-1 :Adjuvant chemotherapy with gemcitabine and cisplatin compared to observation after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma
Dr Stephen Falk

13. Portfolio ID
Project Title
Site PI
BRAG rating
Planned end date
Recruited
Target
15390
ABC-06: A Phase III, randomised, multicentre, open-label study of active symptom control (ASC) alone or ASC with oxaliplatin/5FU chemotherapy for patients with locally advanced/metastatic biliary tract cancers previously treated with cisplatin/gemcitabine chemotherapy
Great Western Hospitals
Blesing, Dr Claire %
01/11/2017 2 8
University Hospitals Bristol
Falk, Dr Stephen J
-17.55% 6 10
19200
ACELARATE: A Phase III, open label, multicentre randomised clinical study comparing Acelarin (NUC1031) with Gemcitabine in patient with metastatic pancreatic carcinoma.
Yeovil District Hospital
Beaumont, Dr Erica
-38.00%
31/05/2018 1
Weston Area Health
Wells, Dr Tom
-27.73%
31/12/2017 4
30470
BIG ROMIO (RCT of minimally invasive or open oesophagectomy)
Barham, Mr Paul
-6.41%
30/09/2019 68
Royal United Hospitals Bath
Krysztopik, Mr Richard
36.55%
01/12/2018 3 7
4307
ESPAC-4: EUROPEAN STUDY GROUP FOR PANCREATIC CANCER - TRIAL 4. Combination versus single agent chemotherapy in resectable pancreatic ductal and peri-ampullary cancers.
Gloucestershire Hospitals
Candish, Dr Charlie
-36.03%
-23.05%
59.09% 45 30
15037
GO2: Alternative chemotherapy for frail or elderly patients with advanced gastric or oesophageal cancer
Hilman, Dr Serena
-31.80%
31/10/2017
-21.95% 17 29
-8.23%
26.77%
Taunton and Somerset
Walther, Dr Julie
-9.00%
-49.00%
Tillett, Dr Tania
77.77% 16

14. Portfolio ID
Project Title
Site PI
BRAG rating
Planned end date
Recruited
Target
18094
Neo-AEGIS: Randomised Clinical Trial of neoadjuvant and adjuvant chemotherapy (MAGIC regimen) vs. neoadjuvant chemoradiation (CROSS protocol) in adenocarcinoma of the oesophagus and oesophago-gastric junction.
University Hospitals Bristol
Falk, Dr Stephen J
-8.28%
31/12/2018 8 30
8880
OCCAMS - Oesophageal Cancer Clinical and Molecular Stratification. A Multicentre Study to Determine Predictive and Prognostic Biomarkers and Therapeutic Targets for Oesophageal and Junctional Adenocarcinoma including Whole Genome Sequencing.
Gloucestershire Hospitals
Barr, Prof Hugh
93.77%
30/10/2016 50 25
18432
PLATFORM: Planning treatment for oesophago-gastric cancer: a randomised maintenance therapy trial
Weston Area Health
Hilman, Dr Serena
-76.09%
16/02/2020
Elyan, Dr Sean
-12.46% 3 12
38.30% 15 23
Great Western Hospitals
Blesing, Dr Claire
43.52% 4
Taunton and Somerset
Cattell, Dr Emma
-32.00% 7
Yeovil District Hospital
Beaumont, Dr Erica
-19.00% 2
1203
RECaD: Raman spectroscopy for cancer and pre-cancer detection in the oesophagus
Stone, Dr Nick %
08/01/2017
368
14309
ROCS: Radiotherapy after Oesophageal Cancer Stenting Study
Blazeby, Prof Jane
-20.45%
30/09/2018 20 48
Walther, Dr Julie
39.00% 5 6
21.13%
31/03/2018

15. Portfolio ID
Project Title
Site PI
BRAG rating
Planned end date
Recruited
Target
13859
ROMIO feasability: RCT of minimally invasive or open oesophagectomy v1
University Hospitals Bristol
Blazeby, Prof Jane
454.20%
31/08/2015
123 20
18700
SCALOP-2: A multi-centre randomised study of induction chemotherapy followed by capecitabine (+/-nelfinavir) with high or standard dose radiotherapy for locally advanced non-metastatic pancreatic cancer
Falk, Dr Stephen J
13.08%
31/05/2021 9 31
20358
SCOPE 2: A randomised Phase II/III trial to study radiotherapy dose escalation in patients with oesophageal cancer treated with definitive chemoradiation with an embedded Phase II trial for patients with a poor early response using PET
-3.10%
01/04/2022 1 25
1752
ST03: A Randomised Phase II/III trial of Peri-operative Chemotherapy with or without Bevacizumab in Operable Oesophagogastric Adenocarcinoma
Gloucestershire Hospitals
Elyan, Dr Sean
-37.07%
31/03/2017 15 18
Great Western Hospitals
Blesing, Dr Claire
531.17% 19 3
20859
Developing a system for cancer patients to report symptoms online (eRAPID): Testing the usability of the eRAPID system with surgical patients and staff
12.78%
31/12/2017 28 45
12435
An analysis of Relative Telomere Length (RTL) during chemotherapy in patients with advanced gastro-oesophageal adenocarcinoma
Taunton and Somerset
Cattell, Dr Emma
-2.00%
31/12/2018 5 8

16. Current issues with cancer research locally
Gaps in the portfolio
Clinical pressures with some trial treatments
Pharmacy capacity issues
Extra time for administration of infusions
Extra length of treatment courses
Clinic space to see patients
Affordability to the NHS of the drugs we are researching
What should our regional portfolio look like?
Should we consider the whole region population when forecasting for trials?
Should we encourage more cross referral of patients for studies?
Should we select studies that will be more useful to the NHS?

17. Useful links https://www.crn.nihr.ac.uk/
National and local network information including training programmes templates, tools, contacts, videos etc
Open data platform. Look at performance across whole CRN including all specialty areas
/csg.ncri.org.uk/portfolio/portfolio-maps/
View current national portfolio of open, closed and ‘in set up’ cancer studies
See where a study is open across the country
Search for a study to fit criteria. Good for horizon scanning, eligibility criteria

18. Contacts Research Delivery Manager – maxine.taylor@nihr.ac.uk
Cancer portfolio facilitator –
Upper GI cancer research lead –