Colorectal Cancer SSG Research report: April 2015
Maxine Taylor, Senior Research Delivery Manager (RDM)
At the last meeting it was agreed that nominations for research lead for the group would be sent to the chair. This role could double up as colorectal
research specialty lead for the CRN: West of England as discussed last time. The two roles carry similar responsibility in terms of taking a network wide view
of the colorectal portfolio of studies and engaging clinicians to promote research opportunities to patients and meet the nationally set objectives for the
network. There will also be a requirement to report back to the SSG and lead discussion on research priorities as well as linking with the national clinical
studies group, attend at least one national meeting per year. Steve Falk has put his name forward for this role.
Key points for discussion:
1. The portfolio is generally sparse at present and referrals to sites where studies are open is encouraged. Available studies are listed below. Studies on the
national portfolio still open to new sites are also listed below.
2. FOCUS4 has the potential to recruit lots of patients but has been slow to start. New drugs are now coming through and this information needs to be
widely disseminated with clinicians encouraged to discuss with suitable patients. Open at all sites.
3. The Add Aspirin trial offers the opportunity for a high recruiting interesting study open to all sites. This study is about to be launched nationally and most
sites in the West of England have undertaken feasibility.
4. Network wide we are one of the highest recruiters into PulMICC. This study is only open at UHB within West of England.
5. Cancer specific objectives have been set by the Clinical Research Network and are on the following page. The recruitment objectives of 20% of incidence
overall and 7.5% of incidence into interventional studies were achieved for 2014-15 in West of England.
6. Recruitment into colorectal studies is shown in the graph and table below for the last financial year for each Trust. Information is taken from the national
recruitment database.
7. Further information about individual studies can be found at: http://public.ukcrn.org.uk/search/
8. For further information about local research activity please contact Maxine.taylor@nihr.ac.uk.
This report includes all research activity in CRN: West of England as well as Taunton and Yeovil.
National Specialty Objectives: 2015/16 objectives mapped to domains
DOMAIN 1: INCREASING THE BREADTH OF RESEARCH ENGAGEMENT IN THE NHS
Increasing the opportunities for patients to participate in NIHR CRN Portfolio studies
ID
Specialty
Objective
Measure
1.1
Cancer
Increase the opportunities for cancer patients to take
part in research studies, regardless of where they live,
as reflected in National Cancer Patient Experience
Survey responses
Number of LCRNs which have an action plan to increase access
in each subspecialty (eg by opening studies, increasing
awareness and forming referral pathways for access to
research)
National Target
15
DOMAIN 2: PORTFOLIO BALANCE
Delivering a balanced portfolio (across and within Specialties) that meets the needs of the local population and takes into account
national specialty priorities
ID
Specialty
Objective
Measure
2.2
Cancer
Increase the number of cancer patients participating in
studies, to support the national target of 20% cancer
incidence
Number of LCRNs recruiting at or above the national target of
20%, or with an increase compared with 2014-15
15
2.3
Cancer
Increase the number of cancer patients participating in
interventional trials, to support the national target of
7.5% cancer incidence
Number of LCRNs recruiting at or above the national target of
7.5%, or with an increase compared with 2014-15
15
2.4
Cancer
Deliver a Portfolio of studies including challenging trials
in support of national priorities
Number of LCRNs recruiting into studies in:
15




National Target
Cancer Surgery
Radiotherapy
Rare cancers (cancers with incidence <6/100,000/year)
Children's Cancer & Leukaemia and Teenagers &
Young Adults
DOMAIN 3: RESEARCH INFRASTRUCTURE
Developing research infrastructure (including staff capacity) in the NHS to support clinical research
ID
Specialty
Objective
Measure
National
Target
3.1
Cancer
Establish local clinical leadership and a defined portfolio
across the cancer subspecialty areas
Number of LCRNs with, for each of the 13 Cancer
subspecialties, a named lead and a defined portfolio of
available studies
15
Recruitment to Colorectal studies by study design type by CRN: West of England partner organisations
(April 14 - March 15)
90
80
70
44
60
50
40
30
19
23
20
7
10
8
15
1
3
0
Gloucestershire
Hospitals NHS
Foundation Trust
39
Great Western
Hospitals NHS
Foundation Trust
13
6
North Bristol NHS
Royal United
Trust
Hospital Bath NHS
Trust
Interventional
11
10
3
1
Taunton and
University Hospitals Weston Area Health Yeovil District
Somerset NHS
Bristol NHS
NHS Trust
Hospital NHS
Foundation Trust Foundation Trust
Foundation Trust
Observational
Current colorectal portfolio of
recruiting studies
Access to Cancer Therapies (ACT)
Aristotle
COPERNICUS
CORGI
CReST
Does aspirin increase the clinical response to
chemo-radiotherapy?
FIAT Study
FOCUS-4: Molecular selection of therapy in
colorectal cancer
FOXFIRE
FOxTROT
IVICA: Intravenous iron in colorectal cancer
associated anaemia
NSCCG
Pulmonary Metastasectomy in Colorectal
Cancer (PulMICC)
Raman colon diagnostics
RAPPER
STARRCAT Trial: Surgical Timing After
Radiotherapy for Rectal Cancer
The seAFOod Polyp Prevention Trial
Gloucestershir
e Hospitals
NHS
Foundation
Trust
Great
Western
Hospitals
NHS
Foundati
on Trust
North
Bristol
NHS
Trust
Royal
United
Hospital
Bath NHS
Trust
Taunton
and
Somerset
NHS
Foundation
Trust
1
University
Hospitals
Bristol NHS
Foundation
Trust
15
9
2
11
Weston
Area
Health
NHS
Trust
10
1
5
8
2
2
1
3
1
5
4
3
Yeovil
District
Hospital
NHS
Foundation
Trust
Grand Total
25
1
11
2
11
1
6
8
2
1
4
1
2
1
4
1
2
10
2
13
1
2
1
2
9
20
20
9
33
3
9
2
22
12
1
2
9
1
25
12
2
14
Timing of Surgery after preoperative
radiotherapy 6 vs 12 weeks
TOTALS
2
34
4
14
20
2
34
83
11
3
203
The following table shows studies on the national colorectal portfolio open to new sites – April 2015. Some of these will be open and/or in set up within the
region already. http://public.ukcrn.org.uk/search/ for further information including recruitment criteria etc
ISRCTN Acronym & Title
Status
Type
Open to additional
sites
743586 Add-Aspirin - A phase III double-blind placebo-controlled randomised trial assessing the effects of aspirin on In Set-Up Interventional Yes, within and
48
disease recurrence and survival after primary therapy in common non-metastatic solid tumours.
NHS
outside lead country
Permission
Received
093514 Aristotle - A phase III trial comparing standard versus novel CRT as pre-operative treatment for MRI defined Open
47
locally advanced rectal cancer
Interventional Yes, within and
outside lead country
Beyond TME - The role of MRI in improving surgical technique and outcomes in exenterative pelvic surgery Open
for locally extensive primary or recurrent rectal cancer
Interventional Yes, within and
and
outside lead country
Observational
BRIGHTLIGHT: The 2012 TYA Cancer Cohort Study - Do specialist cancer services for teenagers and young Open
adults (TYA) add value?
Observational Yes, within
country only
lead
101331 CAPITAL - A dose finding study evaluating the safety and tolerability of Capecitabine and Aflibercept in Open
62
patients with unresectable metastatic colorectal cancer deemed unsuitable for doublet/ triplet
chemotherapy
Interventional Yes, within
country only
lead
COGS2 - Colorectal Cancer Genetic Susceptibility Study 2
Open
Observational Yes, within and
outside lead country
CONSCOP - A feasibility randomised controlled trial (RCT) of contrast enhanced vs non-enhanced In Set-Up Interventional -unknowncolonoscopy in index bowel cancer screening to reduce bowel cancer mortality
NHS
Permission
Received
CORGI - The Genetic Study of Colorectal Cancer Families without known inherited predispositions
Open
Deferral of Surgery - Timing and Deferral of Rectal Surgery Following a Continued Response to Pre-operative Open
Chemoradiotherapy
Observational Yes, within and
outside lead country
Observational Yes, within
country only
lead
EORTC 40091/ BOS2 - Randomized phase II trial evaluating the efficacy of FOLFOX alone, FOLFOX plus In Set-Up Interventional Yes, within and
bevacizumab and FOLFOX plus panitumumab as perioperative treatment in patients with resectable liver Pending
outside lead country
metastases from wild type KRAS colorectal cancer
NHS
Permission
FIAT Study - The Fistula-In-Ano trial comparing Surgisis anal fistula plug versus surgeon's preference for Open
transsphincteric fistula-in-ano
Interventional Yes, within
country only
lead
871632 FOxTROT - Fluoropyrimidine, Oxaliplatin & Targeted Receptor pre-Operative Therapy for colon cancer. A Open
46
randomised trial assessing whether preoperative chemotherapy and/or an anti-EGFR monoclonal antibody
improves outcome in high-risk operable colon cancer.
Interventional Yes, within and
outside lead country
256164 HART - Hughes Abdominal Repair Trial
90
Interventional Yes, within and
outside lead country
Open
HEAL
CRC:
DCT - Open
Eliciting peoples’ preferences for Healthy Eating and Active Lifestyle Intervention After Treatment for Colore
ctal Cancer using Discrete Choice Experiments.
Observational Yes, within
country only
IMPRESS Trial - Improving radical treatment through MRI evaluation of pelvic sigmoid cancers (the IMPRESS Open
trial)
Interventional Yes, within and
outside lead country
InterAACT - A Multicentre Randomised Phase II Advanced Anal Cancer Trial
Open
Interventional Yes, within and
outside lead country
MARVEL - Molecular pAthologic and MRI investigation of the prognostic and redictive importance of Open
extramural VEnous invasion in rectaL cancer
Observational Yes, within and
outside lead country
MERCURY 2 - Low Rectal Cancer Study
Observational Yes, within and
outside lead country
Open
lead
MicroRNA Expression in Ulcerative Colitis and UCCancer - MicroRNA expression profiles in blood and Open
tissues from patients with ulcerative colitis: identifying biomarkers for progression to cancer.
Observational Yes, within
country only
lead
Non-invasive diagnostic testing for Gastro-intestinal disease - Non-invasive testing for the diagnosis and Open
assessment of Gastro-intestinal disease
Observational Yes, within
country only
lead
Predisposition to serrated neoplasia and tumours (PRESENT) study - An investigation of genetic factors Open
involved in predisposition to and pathogenesis of serrated polyps and cancers of the large bowel: The
Predisposition to Serrated Neoplasia and Tumours (PRESENT) study
950375 PROSPECT - Improving the prediction of metastatic disease in primary colorectal cancer - Improving the Open
15
prediction of metastatic disease in primary colorectal cancer: Prospective multicentre evaluation of a
prognostic model of conventional predictive variables and novel variables derived from perfusion computed
tomography
Observational Yes, within
country only
lead
Interventional Yes, within and
outside lead country
Pulmonary Metastasectomy in Colorectal Cancer (PulMICC) - A Randomised feasibility study of Pulmonary Open
Metastasectomy in Colorectal Cancer
Interventional Yes, within
country only
lead
RAPPER - Radiogenomics: assessment of polymorphisms for predicting the effects of radiotherapy
Observational Yes, within
country only
lead
Open
SERENADE - SERENADE: Screening for synchronous metastases in colorectal cancer using Hepatic Diffusion Open
weighted MRI.
059268 The seAFOod Polyp Prevention Trial - A randomised controlled trial of eicosapentaenoic acid (EPA) and/or Open
47
aspirin for colorectal adenoma (or polyp) prevention during colonoscopic surveillance in the NHS Bowel
Cancer Screening Programme: The seAFOod (Systematic Evaluation of Aspirin and Fish Oil) polyp prevention
trial.
Interventional Yes, within and
and
outside lead country
Observational
Interventional Yes, within
country only
lead