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:
8. For further information about local research activity please contact .
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
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) / 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
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:
- 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
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
Current colorectal portfolio of recruiting studies / Gloucestershire Hospitals NHS Foundation Trust / Great Western Hospitals NHS Foundation Trust / North Bristol NHS Trust / Royal United Hospital Bath NHS Trust / Taunton and Somerset NHS Foundation Trust / University Hospitals Bristol NHS Foundation Trust / Weston Area Health NHS Trust / Yeovil District Hospital NHS Foundation Trust / Grand Total
Access to Cancer Therapies (ACT) / 15 / 10 / 25
Aristotle / 1 / 9 / 1 / 11
COPERNICUS / 2 / 2
CORGI / 11 / 11
CReST / 1 / 1
Does aspirin increase the clinical response to chemo-radiotherapy? / 5 / 8 / 4 / 8 / 25
FIAT Study / 3 / 6 / 2 / 1 / 12
FOCUS-4: Molecular selection of therapy in colorectal cancer / 2 / 4 / 1 / 2 / 1 / 10
FOXFIRE / 2 / 2
FOxTROT / 1 / 5 / 4 / 1 / 2 / 13
IVICA: Intravenous iron in colorectal cancer associated anaemia / 2 / 2
NSCCG / 3 / 1 / 3 / 1 / 1 / 9
Pulmonary Metastasectomy in Colorectal Cancer (PulMICC) / 20 / 20
Raman colon diagnostics / 9 / 9
RAPPER / 2 / 22 / 9 / 33
STARRCAT Trial: Surgical Timing After Radiotherapy for Rectal Cancer / 1 / 1 / 2
The seAFOod Polyp Prevention Trial / 12 / 2 / 14
Timing of Surgery after preoperative radiotherapy 6 vs 12 weeks / 2 / 2
TOTALS / 34 / 4 / 14 / 20 / 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. for further information including recruitment criteriaetc
ISRCTN / Acronym & Title / Status / Type / Open to additional sites74358648 / Add-Aspirin- A phase III double-blind placebo-controlled randomised trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common non-metastatic solid tumours. / In Set-Up NHS Permission Received / Interventional / Yes, within and outside lead country
09351447 / Aristotle- A phase III trial comparing standard versus novel CRT as pre-operative treatment for MRI defined locally advanced rectal cancer / Open / Interventional / Yes, within and outside lead country
Beyond TME- The role of MRI in improving surgical technique and outcomes in exenterative pelvic surgery for locally extensive primary or recurrent rectal cancer / Open / Interventional and Observational / Yes, within and outside lead country
BRIGHTLIGHT: The 2012 TYA Cancer Cohort Study- Do specialist cancer services for teenagers and young adults (TYA) add value? / Open / Observational / Yes, within lead country only
10133162 / CAPITAL- A dose finding study evaluating the safety and tolerability of Capecitabine and Aflibercept in patients with unresectable metastatic colorectal cancer deemed unsuitable for doublet/ triplet chemotherapy / Open / Interventional / Yes, within lead country only
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 colonoscopy in index bowel cancer screening to reduce bowel cancer mortality / In Set-Up NHS Permission Received / Interventional / -unknown-
CORGI- The Genetic Study of Colorectal Cancer Families without known inherited predispositions / Open / Observational / Yes, within and outside lead country
Deferral of Surgery- Timing and Deferral of Rectal Surgery Following a Continued Response to Pre-operative Chemoradiotherapy / Open / Observational / Yes, within lead country only
EORTC 40091/ BOS2- Randomized phase II trial evaluating the efficacy of FOLFOX alone, FOLFOX plus bevacizumab and FOLFOX plus panitumumab as perioperative treatment in patients with resectable liver metastases from wild type KRAS colorectal cancer / In Set-Up Pending NHS Permission / Interventional / Yes, within and outside lead country
FIAT Study- The Fistula-In-Ano trial comparing Surgisis anal fistula plug versus surgeon's preference for transsphincteric fistula-in-ano / Open / Interventional / Yes, within lead country only
87163246 / FOxTROT- Fluoropyrimidine, Oxaliplatin & Targeted Receptor pre-Operative Therapy for colon cancer. A randomised trial assessing whether preoperative chemotherapy and/or an anti-EGFR monoclonal antibody improves outcome in high-risk operable colon cancer. / Open / Interventional / Yes, within and outside lead country
25616490 / HART- Hughes Abdominal Repair Trial / Open / Interventional / Yes, within and outside lead country
HEAL CRC: DCT- Elicitingpeoples’preferencesforHealthyEatingandActiveLifestyle InterventionAfterTreatmentforColorectalCancerusingDiscrete ChoiceExperiments. / Open / Observational / Yes, within lead country only
IMPRESS Trial- Improving radical treatment through MRI evaluation of pelvic sigmoid cancers (the IMPRESS trial) / Open / 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 extramural VEnous invasion in rectaL cancer / Open / Observational / Yes, within and outside lead country
MERCURY 2- Low Rectal Cancer Study / Open / Observational / Yes, within and outside lead country
MicroRNA Expression in Ulcerative Colitis and UCCancer- MicroRNA expression profiles in blood and tissues from patients with ulcerative colitis: identifying biomarkers for progression to cancer. / Open / Observational / Yes, within lead country only
Non-invasive diagnostic testing for Gastro-intestinal disease- Non-invasive testing for the diagnosis and assessment of Gastro-intestinal disease / Open / Observational / Yes, within lead country only
Predisposition to serrated neoplasia and tumours (PRESENT) study- An investigation of genetic factors involved in predisposition to and pathogenesis of serrated polyps and cancers of the large bowel: The Predisposition to Serrated Neoplasia and Tumours (PRESENT) study / Open / Observational / Yes, within lead country only
95037515 / PROSPECT - Improving the prediction of metastatic disease in primary colorectal cancer- Improving the 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 / Open / Interventional / Yes, within and outside lead country
Pulmonary Metastasectomy in Colorectal Cancer (PulMICC)- A Randomised feasibility study of Pulmonary Metastasectomy in Colorectal Cancer / Open / Interventional / Yes, within lead country only
RAPPER- Radiogenomics: assessment of polymorphisms for predicting the effects of radiotherapy / Open / Observational / Yes, within lead country only
SERENADE- SERENADE: Screening for synchronous metastases in colorectal cancer using Hepatic Diffusion weighted MRI. / Open / Interventional and Observational / Yes, within and outside lead country
05926847 / The seAFOod Polyp Prevention Trial- A randomised controlled trial of eicosapentaenoic acid (EPA) and/or 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. / Open / Interventional / Yes, within lead country only