the bctu coloproctology trials newsletter …...the royal marsden hospital (sutton) 61 stepping hill...
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Merry Christmas and Happy New Year from the Coloproctology Trials Team at Birmingham Clinical Trials
Unit!
Welcome to the Christmas 2010 issue of the Coloproctology Trials newsletter from all at BCTU.
The coloproctology portfolio at BCTU includes FOxTROT, CReST, FIAT, TREC, DREAMS
PROSPER, QUASAR and now also ROCSS.
The BCTU Coloproctology Trials
Newsletter
December 2011
Contents this Issue: FOxTROT Phase III trial update
Updates from the ongoing CReST, FIAT and TREC trials. 1st update from the DREAMS trial Surgical Trials Nurses Meeting Announcement
Thank you to everyone who has participated in our studies over this past year, both old collaborators
and those new ones joining us in 2011! We hope that you continue to support us and the coloproctology
trials to help improve outcomes for future patients. All of the trials in the coloproctology portfolio will
only be a success through your wholehearted support—so thank you for all of your time and efforts!
300 Patients Now Entered into the FOxTROT Trial 2011 has seen a steady increase in recruitment with patients now randomised from over 60 sites and the study now
open at 76 UK centres with more centres to follow in 2012. With the widening of the eligibility criteria to include all CT-
staged T3 tumours, the introduction of FOxTROT ‘lite’ and the re-introduction of OxCap for those patients not eligible
for panitumumab, recruitment has steadily increased.
Thank you to everyone involved at our randomising and newly opened centres, with your continued support recruit-
ment to FOxTROT will increase and we will achieve our target!
FOxTROT Pilot Trial Results Meeting and Publication
The FOxTROT Pilot Trial results meeting was held earlier
this year in Birmingham. The study recruited to target
with 150 patients randomised. The pilot trial demon-
strated the accuracy of radiological staging, the feasibility,
safety and tolerance of neoadjuvant chemotherapy and
pathological evidence of tumour downstaging with 6
weeks of pre-operative chemo.
The pilot trial paper is currently being finalised and will be
submitted in January. All collaborators will be informed as
soon as the paper has been accepted and as is the case
with all FOxTROT publications, all collaborators will be
cited as co-authors.
Removal of FOxTROT Arm D: Postoperative Panitumumab
Post-operative panitumumab has now been removed
from the FOxTROT trial. This follows the publication of the
results from the Intergroup N0147 study which closed
early after randomisation of 1,760 KRAS-wildtype stage III
colon cancer patients to FOLFOX ± cetuximab. The study
found no improvement in disease-free survival, significant
additional toxicity and worse compliance with chemother-
apy in the cetuximab arm. Continued overleaf.
FOxTROT - Update
Open Centre Open Centre Open Centre Open Centre
Local PI Local PI Local PI Local PI
1 Queen Elizabeth, Birmingham
20 Harrogate District Hospital
39 Russells Hall
58 Wythenshawe Hospital
Dr Neil Steven Dr Kim Last Prof David Ferry Dr Mike Braun
2 Derriford Hospital
21 Leighton Hospital
40 Castle Hill
59 Salisbury District
Miss Clare Adams Dr Mike Braun Dr Rajarshi Roy Dr Tim Iveson
3 Royal Lancaster Hospital
22 West Middlesex
41 The Royal Marsden Hospital (Fulham)
60 York Hospital
Dr David Eaton Dr Rizvana Ahmad Prof David Cunningham Dr Kim Last
4 Leeds General Hospital
23 Southend Hospital
42 The Royal Marsden Hospital (Sutton)
61 Stepping Hill Hospital
Prof Matt Seymour Dr David Tsang Prof David Cunningham Dr Jurjees Hasan
5 Queen Elizabeth, Gateshead
24 North Staffordshire Hospital
43 Southampton General Hospital
62 South Tyneside District General
Dr Werner Dobrowsky Dr Fawzi Adab Dr Andrew Bateman Dr Ashraf Azzabi
6 Huddersfield Royal Infirmary
25 Northern Centre Cancer Treatment
44 Barnsley District General Hospital
63 Mid-Yorks NHS Trust
Dr Jo Dent Dr Fareeda Coxon Dr Debra Furniss Dr Daniel Swinson
7 Sandwell General Hospital
26 Southport & Ormskirk Hospital
45 Royal Devon & Exeter
64 Royal Preston/Sharoe Green Hospital
Mr Neil Cruickshank Dr Arthur Sun-Myint Dr Melanie Osborne Mr Nigel Scott
8 Charing Cross Hospital
27 Clatterbridge Oncology Centre
46 Heartlands Hospital
65 Chesterfield Royal Hospital
Dr Charles Lowdell Dr David Smith Mr Charles Hendrickse Dr Debra Furniss
9 Manor Hospital
28 Doncaster Royal Infirmary
47 Hope, Salford
66 City Hospital, Birmingham
Dr Andrew Hartley Dr Jonathon Wadsley Mr Nicholas Lees Mr Neil Cruickshank
10 Royal Bournemouth General
29 Wexham Park Hospital
48 St George's Hospital
67 St Mary’s Paddington
Dr Tamas Hickish Dr Marcia Hall Dr Fiona Lofts Dr Suzy Cleator
11 Poole General Hospital
30 Weston Park Hospital
49 Queens Medical Centre
68 Raigmore
Dr Tamas Hickish Dr Joanna Hornbuckle Dr Vanessa Potter Dr David Whillis
12 North Middlesex Hosptial
31 Bradford Royal Infirmary
50 Royal CornwallHospital
69 Worcester
Dr John Bridgewater Dr Andy Conn Dr Richard Ellis Dr David Farrugia
13 Dorset County Hospital
32 Frenchay & Southmead Hospitals
51 New Cross Hospital
70 Bangor
Dr Richard Osbourne Dr Kirsten Hopkins Dr Simon Grummet Dr Catherine Bale
14 Mount Vernon Hospital
33 Musgrove Park Hospital
52 Good Hope Hospital
71 UCLH
Dr Rob Glynne-Jones Dr Julie Walther Dr John Glaholm Prof Daniel Hochhauser
15 Royal Free Hospital
34 The Whittington Hospital
53 Queen Alexandra Hospital
72 Macclesfield
Dr Astrid Mayer Dr Pauline Leonard Dr Muthuramalingam Dr Catherine McBain
16 Bristol Royal Infirmary
35 Manchester Royal Infirmary
54 Ipswich Hospital
73 Countess of Chester
Mr Mike Thomas Mr Jim Hill Dr Rubin Soomal Mr Dale Vimalachandran
17 Scunthorpe General Hospital
36 The Christie
55 Glan Clwyd Hospital
74 Warrington & Halton
Dr Abdel Hamid Dr Mark Saunders Dr Simon Gollins Dr Adrian Moss
18 Diana Princess of Wales
37 Royal Liverpool Hospital
56 North Hampshire& Basingstoke
75 Weston General (WSM)
Dr Rajarshi Roy Mr Paul Rooney Dr Charlotte Rees Dr Marjorie Tomlinson
19 Queens Hospital (Romford)
38 The Princess Alexandra
57 Arrowe Park/Clatterbridge
76 Wrexham Maelor
Dr Sherif Raouf Dr John Bridgewater Dr Nicholas Day Dr Simon Gollins
FOxTROT Top Recruiters! The top three recruiting sites in
FOxTROT are:
1st University Hospital North Staffs
2nd Sandwell General Hospital
Joint 3rd: Charing Cross & St James’s University Hospital,
Leeds. Thank you & well done to the teams at those sites!
The centres that are currently participating in the FOxTROT trial are listed below.
Congratulations to the sites highlighted in red—all have already randomised at least 1 patient!
Removal of Post-Operative Panitumumab Due to the disappointing results in N0147, post-operative
panitumumab has now been removed. Please note, that
the randomisation to ± pre-operative panitumumab con-
tinues due to the definitive evidence that anti-EGFR mAb
therapy increases response rate and progression free sur-
vival time for macroscopic, KRAS-wildtype tumours.
The new version of the protocol will be circulated in Janu-
ary 2012, please con tact the team at BCTU if you have any
questions.
FOxTROT Patient DVD We have now produced a patient DVD to supplement the
patient consent process. The DVD has been produced in
conjunction with CRUK and over 125 copies have already
been distributed. If you have used the DVD we would be
delighted to receive your feedback and if you would like
additional copies then please contact the FOxTROT team.
FOxTROT To Open Internationally! Following the enthusiastic reception for FOxTROT at ASCO
2011, the study is set to open internationally early next
year.
In December, we held a launch meeting in Denmark
where several Danish hospitals signed up to participate in
the trial. We now plan to open to recruitment in early
2012.
Additionally, ASCO generated much interest from a con-
sortium in Austria and from centres in both France and
America where we hope to run parallel studies to the
trial!
The CReST Trial - Update
CReST is now the biggest and only ongoing colorectal stent trial!
Almost 130 patients now
randomised into CReST!
Recruitment to CReST is gathering
momentum! We now have 50 sites
open to recruitment and almost 130
patients randomised! Thank you to all
sites which have randomised a pa-
tient!
Top Recruiters!
Congratulations & thank
you to the team at
St James’s University
Hospital Leeds who were
our best recruiter this
year! There was tough competition
for 2nd place but MRI won and Brad-
ford Royal Infirmary came 3rd!
Open Centres Local PI Open Centres Local PI 1 Addenbrooke's Hospital Miss Nicola Fearnhead 27 North Tees and Hartlepool Mr Talvinder Gill
2 Bradford Royal Infirmary Professor Clive Kay 28 Northwick Park Hospital/ St Marks Dr Arun Gupta
3 Warwick Hospital Mr James Francombe 29 Princess of Wales Hospital Mr Barry Appleton
4 Darent Valley Hospital Mr Michael Parker 30 Queen Alexandra Hospital, Portsmouth Ms Asha Senapati
5 Derby City General Hospital Dr Rajeev Singh 31 Queen Elizabeth – Birmingham Dr Colm Forde
6 Derriford Hospital Ms Clare Adams 32 Queen Elizabeth – Gateshead Mr Mark Katory
7 Frimley Park Hospital Mr David P. Edwards 33 Queens Hospital (Romford) Dr P Premchand
8 Gartnavel Hospital Dr S Chandramohan 34 Queens Medical Centre Mr Nicholas C. Armitage
9 Glasgow Royal Infirmary Dr S Chandramohan 35 Raigmore Hospital Professor Angus J M Watson
10 Harrogate District Hospital Mr David Leinhardt 36 Royal Albert Edward Infirmary Mr Marius Paraoan
11 Imperial College Hospital Mr Peter Dawson 37 Royal Cornwall Hospital Mr William Faux
12 Ipswich Hospital Dr Avijit Basu 38 Royal Devon & Exeter Miss Patricia Boorman
13 James Paget University Hospital Mr Roshan Lal 39 Royal Sussex County Hospital Mr Marc Lamah
14 John Radcliffe Hospital Dr Raman Uberoi 40 Russells Hall Hospital Dr Sauid Ishaq
15 Kings College Hospital Proffesor Suzanne Ryan 41 Salisbury District Mr Simon Sleight
16 Leeds General Hospital Dr Damian Tolan 42 Salford Royal Hospital Mr Nicholas Lees
17 Leicester General / Royal Infirmary Mr Baljit Singh 43 Scarborough General Hospital Dr Ian Renwick
18 Leighton Hospital Mr Chelliah Selvasekar 44 Scunthorpe General Hospital Mr Syed Ahmed
19 Manchester Royal Infirmary Mr Jim Hill 45 The Royal Bolton Hospital Dr Anthony Maxwell
20 Mid Yorks (Pinderfields / Dewsbury) Mr Christopher Macklin 46 The Ulster Hospital Dr Grant Caddy
21 Musgrove Park Hospital Dr Rudi Matull 47 Southmead/Frenchay (North Bristol) Miss Anne Pullyblank
22 Neville Hall Hospital Dr Nick Cross 48 University Hospital Of North Durham Mr Jagmohan Varma
23 Newcastle (Freeman Hospital) Mr Barry Appleton 49 Western General Hospital Mr Hugh Paterson
24 North Devon District Hospital Mr Mark Cartmell 50 Whipps Cross University Hospital Mr Pasquale Giordano 25 North Manchester General Hospital Dr Richard Hammonds 51 Yeovil District Hospital Mr Jonathan Ockrim
26 Northern General Hospital (Sheffield) Mr Steven Brown
In May 2011, the 99th patient was randomised
into CReST—this made CReST the largest ever
colorectal stenting trial!
The independent Data Monitoring Committee has
met three times and reviewed the unblinded data,
they do not have any concerns about the success
rate of stenting in the trial or concerns about the
complications of stenting.
A paper on the first 50 stented patients is cur-
rently in draft and we hope to submit that early in
the new year.
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40
60
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120
140
160
Act
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Actual recruitment
per month
Open sites
Target active sites
Actual active sites
Actual cumulative recruitment
Target cumulative
recruitment
The TREC Trial—Update
Centre Local PI
1 Good Hope Hospital Stephan Korsgen
2 University Hospital, Birmingham Simon Bach
3 John Radcliffe Hospital Chris Cunningham
4 Colchester General Hospital Matthew Tutton
5 St Richard’s Hospital, Chichester Jay Simson
6 Bradford Royal Infirmary Mark Steward
7 St James University Hospital David Sebag-Montefiore
The TREC Trial Is Now Open To Recruitment! The TREC trial is a phase II feasibility study to compare radical TME surgery versus short course
pre-operative radiotherapy with delayed local excision for the treatment of early rectal cancer.
TREC Objectives TREC aims to assess the feasibility & inform the de-
sign of a large, phase III, multi-centre RCT.
Primary Objective:
Recruitment: To develop effective strategies for ran-
domising patients. Recruitment will be measured at
12, 18 and 24 months.
Secondary Objectives
Safety: Comparison of morbidity/mortality in both
arms.
Efficacy: To demonstrate that SCPRT & TEMS pro-
duces clear tumour downstaging.
Current Status of TREC TREC funding began in late 2011 and so far 7
UK centres are open to the study
A further 8 UK centres are to open early in
2012
Patients have so far been registered from 4
sites.
TREC is on target.
We need 46 patients need to be randomised into
the study over the next 24 months and with the
rapid increase in the number of sites opening,
this is an achievable target!
Open TREC Centres
How To Get Involved:
If you would like to get involved in the TREC trial then please contact the TREC office:
E-mail: [email protected] Tel: 0121 415 9105
The CReST Trial - Update
Research Nurse Appointment
We are delighted to announce that we now have a
new research nurse working on
CReST, Sheila Walsh. Sheila is
based at MRI with the CReST
CI, Mr Jim Hill. Sheila starts in
January and will be contacting
you to arrange visits to your
centre.
CReST To Open Internationally
We have now received ethical approval to open
CReST in South Africa! The site will shortly be
open and we hope to randomise the first patient in
early 2012. Further sites are going through the set
up process in Australia, where we hope to open 3
centres initially.
With our international collaborators coming on-
board, we’re looking forward to an even greater up-
turn in recruitment!
The Fistula-In-Ano Trial - Update
The Fistula-In-Ano Trial comparing Biodesign® Surgisis® anal fistula plug versus surgeon’s preference
for transsphincteric fistula-in-ano.
Trial Design: Patients will be randomised into FIAT trial in a 1:1 ratio of Fistula Plug to Surgeon’s Preference: advancement flap, cutting seton, fistulotomy or LIFT.
Primary Objectives: ·To assess if the anal fistula plug improves symptom specific quality of life
Secondary Objectives are to assess:
· Fistula healing rates · Faecal continence · Complication & re-intervention rates · Cost-effectiveness · Health economic benefits
EUA: High transsphincteric fistula ≥ 1/3 of sphincter complex
Insertion of draining seton
MRI fistulography
RANDOMISE
Fistula Plug Insertion
Surgeons Preference
Advancement Flap
Cutting Seton
Fistulotomy
Research Nurse Appointment Let me take this opportunity to introduce you to the newly appointed FIAT Trial Re-search Nurse, Ms Catherine Moriarty. Catherine in based in Leeds with the FIAT Trial CI, Professor David Jayne. Catherine’s main role will involve visiting sites and carrying out site initiation visits. She will also help you to get your patient pathway in place and be on hand to pro-vide support and advice with regards to patient recruitment into the trial. Catherine's contact details are: [email protected]
The FIAT Trial is now open to recruitment!
We currently have 19 centres open to recruitment and we have recruited 14 Patients.
LIFT Procedure
Baseline MRI Scan The baseline MRI scan should be performed within 6 months of Randomisation in all cases. The majority will be performed in the period between initial EUA with seton insertion and randomisation. After completion of the scan, a reporting proforma—Baseline MRI Form should be completed. Completed Baseline MRI Forms should be forwarded to the trials office along with a copy of the baseline MRI on CD.
A reminder of MRI Scans and timings
Follow-up MRI SCAN MRI follow-up will be done for all patients at ei-ther: 1. Early failure of surgical treatment to evaluate fistula recurrence, OR 2. 12 months after randomised treatment, to as-sess for residual abnormality and confirm healing. This MRI scan should use the same parameters used for baseline imaging.
Status Update: The First patient was recruited in May 2011 from Dorset County Hospital.
We currently have 19 centres open to recruitment and we have recruited 13 Patients.
A huge CONGRATULATIONS and WELL DONE to Mr Michael Thomas
and the Team at DORSET COUNTY HOSPITAL who recruited the first patient into
FIAT in MAY 2011! Thank you for your efforts in getting the first
patient entered into the study.
Open Centres and Recruitment:
CONGRATULATIONS and WELL DONE to the sites highlighted in pink—all have al-ready
A reminder of the Key Eligibility Criteria:
1. Clinical diagnosis of high transsphincteric cryp-toglandular fistula-in-ano. 2. EUA to characterise the nature of the fistula. 3. Fistula tract ≥ 2cm. 4. Single internal fistula opening present at EUA. 5. Draining seton insertion for minimum 6 weeks prior to randomisation. 6. Patients must be > 18. 7. Cryptoglandular aetiology.
Key Inclusion
Criteria:
1. Unable/unwilling to provide informed consent 2. Contraindication to general anaesthesia. 3. Low transsphincteric fistulae. 4. Non-cryptoglandular fistulae e.g. Crohns, obstetric, irra-diation, malignant etc. 5. Other perineal fistulae e.g. rectovaginal fistulae, pouch-vaginal fistulae etc. 6. Complex disease in which more than one internal fistula opening is present 7. Clinical evidence of active perianal sepsis. 8. Cultural or religious objection to the use of pig tissue. 9. Absolute contraindication to MRI scan 10. Patients with recurrent anal fistulae previously treated with a fistula plug.
Key Exclusion
Criteria:
RANDOMISATION NOTEPAD A easy eligibility checklist is provided on the randomisation notepad. Helpful if completed prior to randomisation.
Its not to late to participate in FIAT please contact the Trials team at: FIAT@[email protected]
Or FIAT Trial Coordinator: Ms Manjinder Kaur, Tel: 0121 415 9104;
e-mail: [email protected]
The DREAMS Trial—Dexamethasone Reduces Emesis After Major Colorectal Surgery
Friday
9th March
2012
Objective of DREAMS DREAMS is a phase IV, double-blind, multicentre RCT
which aims to establish if pre-operative dexamethasone re-
duces post-operative nausea and vomiting for patients un-
dergoing elective, bowel resections.
DREAMS is the first joint collaboration between the surgical-
trainee led West Midlands Research Collaborative (WMRC)
and the BCTU.
The 1st patient was randomised into DREAMS
by the team at QE! - Thank you to the whole
team at the site!
Current Status of DREAMS
Funded by the BDRF
Open at 6 UK centres with an additional 20 going
through the set-up phase
18 patients now recruited from the QE, Birmingham
Protocol to be submitted for publication early in 2012 Recruitment on target!
The DREAMS website for randomisation is
now live! Please contact the DREAMS office
to set up your unique username and pass-
word.
How to Get Involved If you would like to participate in the DREAMS trial then
please contact a member of the colo-
rectal team at BCTU (contacts over-
leaf). We would be delighted to have
you onboard!
DATE FOR YOUR DIARY - UPCOMING MEETING Research Nurses Meeting for Colorectal Surgical
Clinical Trials Friday 9th March 2011, Birmingham
We would like to invite all nurses participating in colorectal surgery trials to attend our up-
coming Research Nurses Meeting for Colorectal Surgical Trials.
The meeting will take place on Friday 9th March 2011 at a central location in Birming-ham city centre.
One of the biggest challenges of surgical trials is recruitment: the main focus of this meet-
ing will therefore be specific issues research nurses face in recruiting patients into the trials in the colorectal surgery portfolio.
Sessions will include: Problems in recruitment into the surgical trials.
Overcoming barriers to recruitment into surgical trials.
Brief overviews of the currently recruiting BCTU Colorectal portfolio of surgical trials:
FIAT, CReST, TREC and FOxTROT & DREAMS from the trial Chief Investigators.
This one day meeting will provide an excellent opportunity for Colorectal Research Nurses working on surgical trials to meet and share their experiences.
We would be delighted if you could attend – please save the date. We will be in touch in the new year with a finalised agenda and invitation. In the meantime please contact the
Coloproctology Team to express your interest in attending this exciting meeting or contact
us for further information. ([email protected]; [email protected]; [email protected])
The Coloproctology Team At BCTU
RANDOMISATIONS AND CONTACTS OVER THE CHRISTMAS PERIOD
TELEPHONE RANDOMISATION WILL CLOSE AT 4.00pm ON THURSDAY 22nd DECEMBER 2011 AND REOPEN AT
9am WEDNESDAY ON 4th JANUARY 2012.
For urgent FOxTROT Clinical Queries, please contact the FOxTROT Chief Investigator, Professor Dion Morton on: 07530 593 885
For urgent CReST clinical queries, please contact the CReST Chief Investigator, Mr Jim Hill, on: 07545193094
For urgent FIAT Clinical Queries, please contact the FIAT Chief Investigator, Professor David Jayne on: [email protected] or 0113 206 5281
For urgent DREAMS Clinical Queries, please contact the DREAMS Chief Investigator, Professor Dion Morton on: 07530 593 885
FOxTROT - From 14th December until 4th January 2012 please send blocks for KRAS testing to: Dr Philippe Taniere,
FOxTROT Trial Laboratory, Department of Cellular Pathology, Level –1, QE Hospital Birmingham,
Mindelsohn Way, Edgbaston,
Birmingham, B15 2WB
For urgent randomisation queries for FOxTROT, CReST, FIAT, TREC and DREAMS,
please contact the Coloproctology Trials Manager, Dr Laura Magill on 07966 098477.
Coloproctology Trials Team Leader: Dr Laura Magill, Tel: 0121 415 9105; E-mail: [email protected]
FIAT Trial Coordinator: Ms Manjinder Kaur,
Tel: 0121 415 9104; e-mail: [email protected]
FOxTROT Trial Administrator: Mr James Brown, Tel: 0121 415 9013; e-mail: [email protected]
FOxTROT Data Manager: Mr Andrew Palmer
Tel: 0121 415 9106; e-mail: [email protected]
CReST and DREAMS Trial Administrator: Mrs Manijeh Ghods, Tel: 0121 415 9012; e-mail: [email protected]