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ESPAC-4   

Title

EUROPEAN STUDY GROUP FOR PANCREATIC CANCER (ESPAC) - Trial 4. Combination versus single agent chemotherapy in resectable pancreatic ductal and peri-ampullary cancers.


Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Recruitment
III Treatment Open Over 18 University of Liverpool and RLBUHT Eudract No: 2007-004299-38
Isrctn No: ISRCTN96397434
978

Purpose

Long term survival following resection for pancreatic cancer still needs to be improved. Adjuvant 5-FU/FA demonstrates significant improvement in overall survival following surgery, adjuvant gemcitabine demonstrates a survival advantage following surgical resection for pancreatic cancer. Gemcitabine plus capecitabine improves survival in patients with advanced pancreatic cancer compared with single agent gemcitabine


Trial Lead Organisations

  • The Royal Liverpool and Broadgreen University Hospital Trust
  • University of Liverpool
  • Chief Investigator: Professor John Neoptolemos


Trial Start Date

13/10/2008


Trial Coordinator

Chloe Smith


Trial Coordinator Email Address

chloe.smith@liv.ac.uk


Trial Coordinator Contact No

0151 794 8834


Website Treatment  

ESPAC-4 is a phase III, international, randomised controlled trial which aims to compare gemcitabine against gemcitabine + capecitabine in 1080 patients with ductal adenocarcinoma. It is anticipated that the trial will run in approximately 110 sites within 8 countries and will run for 8 years.

The study will randomise patients into one of two arms up to 12 weeks following pancreatic cancer resection surgery. The two treatment arms will be gemcitabine plus capecitabine versus gemcitabine. If one treatment shows superiority in terms of the primary and secondary endpoints, this could be recommended as a standard treatment in the UK.

Arm 1: Gemcitabine will be administered once a week for three weeks out of every four weeks (one cycle) for six cycles i.e. 24 weeks.

Arm 2: Gemcitabine will be administered on day 1, 8 and 15. Capecitabine will be administered orally for 21 days followed by 7 days? rest. Treatment will be repeated every 4 weeks for a total of 24 weeks

Trial Endpoints  


Primary Outcome  

  • Length of survival


Secondary Outcomes  

  • Toxicity
  • Quality of life
  • Two year survival
  • Five year survival
  • Relapse free survival (RFS)

Eligibility  

Inclusion Criteria:
  • Patients who have undergone complete macroscopic resction for ductal adenocarcinoma of the pancreas (R0 or R1 resection).
  • Completion of all pre-operative investigations.
  • Histological confirmation of the primary diagnosis.
  • Histological examination of all resection margins.
  • Patients randomised within 12 weeks of surgery and can begin treatment within 14 weeks.
  • No evidence of malignant ascites, liver metastasis, spread to other distant abdominal organs, peritoneal metastasis, spread to extra-abdominal organs
  • CT (chest, abdomen, pelvis) scan within 3 months prior to randomisation.
  • A WHO performance status < 2
  • Creatinine clearance = 50ml/min (according to Cockcroft and Gault)
  • Fully recovered from the operation and fit to take part in the trial.
  • Able to attend for administration of the adjuvant therapy.
  • Able to attend for long-term follow-up.
  • Life expectancy > 3 months.
  • No previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix).
  • No serious medical or psychological condition precluding adjuvant treatment.
  • Fully informed written consent given.


Exclusion Criteria:

  • Use of neo-adjuvant chemotherapy or other concomitant chemotherapy.
  • Patients with pancreatic lymphoma.
  • Macroscopically remaining tumour (R2 resection).
  • Patients with TNM Stage IV disease.
  • Patients younger than 18 years.
  • Pregnancy.
  • New York Heart Association Classification Grade III or IV.
  • Previous chemotherapy.
  • All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom.
  • Patients with known malabsorption.
  • Patients with neutrophil counts of <1.5 x 10^9/l.
  • Patients with thrombocyte counts of <100 x 10^9/l.
  • Patients with severe hepatic impairment.


FRANCE

  • 13385 Marseille CEDEX 5, CHU La Timone (Marseille) (Jean-Francois Seitz)
  • 31059 Toulouse, CHU Purpan (Toulouse) (Rosine Guimbaud)
  • 33604 Pessac, Hopital Haut Leveque (Pessac) (Eric Terrebonne)
  • 34295 Montpellier CEDEX 5, Hopital St Eloi (Montpellier) (Bertrand Millat)
  • 69008 Lyon, Hopital Prive Jean Mermoz (Lyon) (Pascal Artru)
  • 75012 Paris, Hopital Saint Antoine (Paris) (Leila Bengrine-Lefevre)
  • 75651 Paris CEDEX 13, Groupe Hospitalier Pitie Salpetriere (Paris) (Jean-Baptiste Bachet)
  • 92118 Clichy CEDEX, Hopital Beaujon (Clichy) (Pascal Hammel)

GERMANY

  • 17475 Greifswald, Ernst-Moritz-Arndt-Universitat Greifswald (Markus Lerch)
  • 69120 Heidelberg, University Hospital Of Heidelberg (Markus Buchler)
  • D-20246 Hamburg, UKE Hamburg (Jakob Izbicki)

SWEDEN

  • 581 85 Linköping, Universitetssjukhuset i Linkoping (Johan Haux)
  • 651 85 Karlstad, Centralsjukhuset i Karlstad (Mattias Elmlund)
  • 856 43 Sundsvall, Lanssjukhuset Sundsvall (Petra Flygare)
  • S-631 88 Eskilstuna, Malarsjukhuset Eskilstuna (Pehr Lind)
  • S-721 89 Västerås, Vastmanlands Sjukhus Vasteras (Andrzej Piwowar)
  • S-901 85 Umeå, Norrlands Universitetssjukhus (Umea) (Niels Hilmer Nielsen)
  • SE-118 83 Stockholm, Karolinska University Hospital (Stockholm) (Jan-Erik Frödin)
  • SE-205 02 Malmö, Skane University Hospital (Malmo) (David Borg)
  • SE-221 85 Lund, Universitetssjukhuset i Lund (David Borg)
  • SE-751 85 Uppsala, Akademiska Sjukhuset (Uppsala) (Bengt Glimelius)

UK: ENGLAND

  • Ashford, William Harvey Hospital (Ashford) (Mathilda Cominos)
  • Ashington, Wansbeck General Hospital (Ashington) (Paula Mulvenna)
  • Barnstaple, North Devon District Hospital (Barnstaple) (Mark Napier)
  • Basingstoke, Basingstoke and North Hampshire Hospital (Charlotte Rees)
  • Bedford, Bedford Hospital, Primrose Oncology Unit (Venkata Ramesh Bulusu)
  • Birmingham, Queen Elizabeth Hospital (Birmingham) (Yuk Ting Ma)
  • Bishop Auckland, Bishop Auckland General Hospital (Fareeda Coxon)
  • Blackburn, Royal Blackburn Hospital (David Chang)
  • Blackpool, Blackpool Victoria Hospital (Muthiah Sivaramalingam)
  • Bournemouth, The Royal Bournemouth Hospital (Tamas Hickish)
  • Bradford, Bradford Royal Infirmary (Sue Cheeseman)
  • Bristol, Bristol Haematology and Oncology Centre (Stephen Falk)
  • Bury St. Edmunds, West Suffolk Hospital (Bury St. Edmunds) (Daniel Patterson)
  • Cambridge, Addenbrooke's Hospital (Cambridge) (Pippa Corrie)
  • Canterbury, Kent and Canterbury Hospital (Mathilda Cominos)
  • Carlisle, Cumberland Infirmary (Carlisle) (Jonathan Nicoll)
  • Cheltenham, Cheltenham General Hospital (Charles Candish)
  • Colchester, Essex County Hospital (Colchester) (Devyanee Basu)
  • Coventry, University Hospital Coventry (Sharmila Sothi)
  • Crewe, Leighton Hospital (Crewe) (Arshad Jamil)
  • Darlington, Darlington Memorial Hospital (Fareeda Coxon)
  • Dartford, Darent Valley Hospital (Dartford) (Jasvinder Kaur)
  • Derby, Royal Derby Hospital (Kate Shankland)
  • Durham, University Hospital of North Durham (Fareeda Coxon)
  • Eastbourne, Eastbourne District General Hospital (Angus Robinson)
  • Exeter, Royal Devon & Exeter Hospital (Elizabeth Toy)
  • Gloucester, Gloucestershire Royal Hospital (Gloucester) (Charles Candish)
  • Great Yarmouth, James Paget Hospital (Great Yarmouth) (Ulrike Dernedde)
  • Grimsby, Diana Princess of Wales Hospital (Grimsby) (Rajarshi Roy)
  • Guildford, Royal Surrey County Hospital (Guildford) (Sebastian Cummins)
  • Hastings, Conquest Hospital (Hastings) (Angus Robinson)
  • Hereford, The County Hospital (Hereford) (Nick Reed)
  • Huddersfield, Huddersfield Royal Infirmary (Emma Rathbone)
  • Huntingdon, Hinchingbrooke Hospital (Huntingdon) (Cheryl Palmer)
  • Ipswich, Ipswich Hospital (Liz Sherwin)
  • Lancaster, Royal Lancaster Infirmary (David Fyfe)
  • Leeds, St. James's University Hospital (Leeds) (Alan Anthoney)
  • Leicester, Leicester Royal Infirmary (Edwina Scott)
  • Liverpool, Royal Liverpool University Hospital (Daniel Palmer)
  • London, Guy's Hospital (London) (Paul Ross)
  • London, Hammersmith Hospital (London) (Harpreet Wasan)
  • London, King's College Hospital (London) (Paul Ross)
  • London, Royal Free Hospital (London) (Roopinder Gillmore)
  • London, Royal Marsden Hospital (London & Sutton) (David Cunningham)
  • London, St. Bartholomew's Hospital (London) (Sarah Slater)
  • Maidstone, Kent Oncology Centre (Maidstone) (Mark Hill)
  • Manchester, The Christie (Manchester) (Juan Valle)
  • Margate, Queen Elizabeth The Queen Mother Hospital (Margate) (Mathilda Cominos)
  • Middlesbrough, James Cook University Hospital (Middlesbrough) (Nick Wadd)
  • Newcastle upon Tyne, Freeman Hospital (Newcastle) (Philip Atherton)
  • Newport, St. Mary's Hospital (Newport, IoW) (Prokopios Dimopoulos)
  • North Shields, North Tyneside General Hospital (North Shields) (Paula Mulvenna)
  • Norwich, Norfolk and Norwich University Hospital (Tom Roques)
  • Nottingham, Nottingham City Hospital (Victoria Brown)
  • Nottingham, Nottingham City Hospital (Michelle Cunnell)
  • Oxford, Churchill Hospital (Oxford) (Kinnari Patel)
  • Peterborough, Peterborough City Hospital (Karen McAdam)
  • Plymouth, Derriford Hospital (Plymouth) (David Sherriff)
  • Poole, Poole Hospital (Richard Osborne)
  • Preston, Royal Preston Hospital (Elaine Young)
  • Redditch, Alexandra Hospital (Redditch) (Kamalnayan Gupta)
  • Romford, Queen's Hospital (Romford) (Sherif Raouf)
  • Salisbury, Salisbury District Hospital (Alaaeldin Shablack)
  • Sheffield, Weston Park Hospital (Sheffield) (Jonathan Wadsley)
  • Shrewsbury, Royal Shrewsbury Hospital (Kathirvelu Dhinakaran)
  • Southampton, Southampton General Hospital (Tim Iveson)
  • Stafford, Stafford Hospital (Caroline Connolly)
  • Stoke-on-Trent, University Hospital North Staffordshire (Stoke) (Arshad Jamil)
  • Swindon, The Great Western Hospital (Swindon) (Claire Blesing)
  • Torquay, Torbay Hospital (Torquay) (Louise Medley)
  • Westcliff-on-Sea, Southend Hospital (Westcliff-on-Sea) (David Tsang)
  • Winchester, Royal Hampshire County Hospital (Winchester) (Luke Nolan)
  • Wirral, The Clatterbridge Cancer Centre (Wirral) (Daniel Palmer)
  • Worcester, Worcestershire Royal Hospital (Worcester) (Kamalnayan Gupta)
  • Yeovil, Yeovil District Hospital (Erica Beaumont)

UK: N. IRELAND

  • Belfast, Belfast City Hospital (Martin Eatock)

UK: SCOTLAND

  • Edinburgh, Western General Hospital (Edinburgh) (Lucy Wall)
  • Glasgow, The Beatson West of Scotland Cancer Centre (Glasgow) (Alec McDonald)
  • Inverness, Raigmore Hospital (Inverness) (Neil McPhail)

UK: WALES

  • Bangor, Ysbyty Gwynedd (Bangor) (Rachel Williams)
  • Bangor, Ysbyty Gwynedd (Bangor) (Anna Mullard)
  • Cardiff, Velindre Hospital (Cardiff) (Tom Crosby)
  • Rhyl, Glan Clwyd Hospital (Rhyl) (Angel Garcia-Alonso)
  • Swansea, Singleton Hospital (Swansea) (Colin Askill)
  • Wrexham, Wrexham Maelor Hospital (Duncan Wilkins)

FRANCE

  • 51092 Reims CEDEX, CHU Robert Debre (Reims) (Stephanie Lagarde)
  • 60021 Beauvais CEDEX, Centre Hospitalier de Beauvais (Suzanne Nguyen)
  • 75014 Paris, Institut Mutualiste Montsouris (Paris) (Brice Gayet)

GERMANY

  • 04103 Leipzig, Universitatsklinikum Leipzig (Joachim Mössner)
  • 44791 Bochum, St. Josef Hospital (Bochum) (Waldemar Uhl)
  • D-81675 Munchen, Klinikum Rechts Der Isar Der TU Munchen (Jörg Kleeff)
  • D-81675 Munchen, Klinikum Rechts Der Isar Der TU Munchen (Jens Siveke)

INDIA

  • , Basavatarakam Indo American Cancer Hospital ( New Contact)
  • , Medanta Hospital ( New Contact)
  • , Nizam's Institute of Medical Sciences ( New Contact)
  • Mumbai-400012, Tata Memorial Centre (Mumbai) (Shailesh Shrikhande)

ITALY

  • 40138 Bologna, Bologna University (Cristina Di Marco)

SWEDEN

  • 413 45 Göteborg, Sahlgrenska Universitetssjukhusetmore (Goteborg) (Tor Ekman)

UK: ENGLAND

  • Northwood, Mount Vernon Cancer Centre (Northwood) (Mark Harrison)
  • Truro, Royal Cornwall Hospital (Truro) (Emma Cattell)

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