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Clinical Trials > ESPAC-3 / ESPAC-3(v2)  

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ESPAC-3 / ESPAC-3(v2)   

Title

European Study Group for Pancreatic Cancer (ESPAC) - Trial 3. Adjuvant Chemotherapies in Resectable Pancreatic Cancer


Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
III Treatment Closed University of Liverpool and RLBUHT Eudract No: N/A
Isrctn No: ISRCTN37494643

Purpose

Pancreatic cancer is one of the major causes of cancer death in Central and Northern European countries as well as in North America, Australasia and Japan 1. Initial treatment involves surgical resection Despite recent improvements in resection rates for localised pancreatic cancer, long-term survival following surgery alone remains poor with a median of 11-15 months, 2-year survival of 20-40% and 5-year survival of around 10% 2, 3. ESPAC-3 was formulated as a result of the ESPAC-1 study.


Trial Start Date

07/07/2000


References

1. Parkin DM, Muir CS, Whelan SL, Sao Y-T, Ferlay J, in the adjuvant setting Powell J. (Eds). Cancer incidence in five continents. Vol VI. Lyon: International Agency for Research on Cancer 1992 (IARC Scientific Publications No. 120) 2. Neoptolemos JP, Russell RCG, Bramhall S, Theis B for the UK Pancreatic Cancer Group. Low mortality following resection for pancreatic and periampullary tumours in 1026 patients: UK survey of pancreatic specialist units. Br J Surg 1997; 84: 1370-6. 3. Beger HG, Link KH, Poch B, Gansauge F. Pancreatic cancer - recent progress in diagnosis and treatment. In: Neoptolemos JP, Lemoine NR (Eds). Pancreatic Cancer: Molecular and Clinical Advances. Oxford, 1996:227-35.


Trial Coordinator

Chloe Smith


Trial Coordinator Email Address

chloe.smith@liv.ac.uk


Trial Coordinator Contact No

0151 794 8834


Website Treatment  

ESPAC-3(v2) is a phase III, international, randomised controlled adjuvant trial in pancreatic cancer comparing 5FU and D-L-Folinic Acid vs. Gemcitabine. The trial is running internationally in over 160 sites in 16 different countries. The trial opened in 2002 and is aiming to finish later this year.
The trial design was amended in 2003 and the study is now called ESPAC-3(v2). Target recruitment for the amended trial is 1030 patients and to be suitable for the study,

Trial Endpoints  

For patients with ductal adenocarcinoma of the pancreas randomised into the two-arm study:

  • Is there any survival difference between gemcitabine and bolus 5FU + folinic acid when used as adjuvant therapy following resection?

For patients with ampullary or other pancreatic tumours randomised into the three-arm study:

  • Does either adjuvant gemcitabine or 5FU + folinic acid improve survival compared to no additional treatment following resection of pancreatic cancer?
  • Is there any survival difference between gemcitabine and 5FU + folinic acid when used as adjuvant therapy following resection?


Primary Outcome  

  • length of survival


Secondary Outcomes  

  • Toxicity
  • Quality of life
  • 5-year survival

Eligibility  

INCLUSION

  • Patients with pancreatitis diagnosed for at least one year
  • Patients with documented HP, clinically defined or proven by genetic mutations in the PRSS1 gene, or patients with ICP and no mutations detected in the PRSS1 gene
  • Patients aged 5-65
  • Patients with characteristic pancreatic pain that is either intermittent or continuous (2 or more episodes during the last 12 months)
  • Patients who have provided written informed consent
  • Patients who are willing to be followed up regularly for at least one year
  • Patients who are able and willing to complete Quality of Life and Pain Assessment questionnaires
  • Patients who are able and willing to provide urine and faecal samples within two weeks of each study visit

EXCLUSION

  • Patients that do not consent to be involved in the trial or patients under the age of 16 whose parents/guardians do not consent for them to be involved in the trial
  • Patients or parents/guardians of underage patients with learning disabilities or other cognitive or sensory impairments that would prevent adequate understanding of the study requirements
  • Patients who are currently receiving treatment with antioxidants or magnesium tablets or have had such treatment in the within the last 3 months
  • Patients who are currently receiving treatment with oral hypoglycaemics or steroids or who have had such treatment within the last 3 months
  • Patients with renal failure (serum creatinine ? 200?mol/l)
  • Patients with atrio-ventricular block
  • Serum triglyceride levels ? 1000mg/dl
  • Patients who are dependent on daily opiate analgesia (morphine or equivalent for more than 12 months)
  • Patients who have chronic hepatic failure, or serious impairment of pulmonary, cardiac, neurological or cerebral function
  • Patients or parents/guardians of underage patients with learning disabilities or other cognitive or sensory impairments that would prevent adequate understanding of the study requirements
  • Patients who are participating in another drug trial
  • Patients who are pregnant
  • All men and women of reproductive potential unless using at least two types of contraception, one of which must be a condom
  • Lactating mothers
  • Patients with any disorder which would prevent adequate absorption of the active treatment
  • Patients suffering from schizophrenia
  • Patients who smoke > 20 cigarettes per day

AUSTRALIA

  • Adelaide, Ashford Cancer Centre (Adelaide) (Brian Stein)
  • Adelaide, Flinders Medical Centre (Adelaide) (Christos Karapetis)
  • Adelaide, Royal Adelaide Hospital (Ian Olver)
  • Adelaide, The Queen Elizabeth Hospital (Adelaide) (Tim Price)
  • Auchenflower, Wesley Medical Centre (Auchenflower) (David Grimes)
  • Bankstown, Bankstown-Lidcombe Hospital (Fred Kirsten)
  • Canberra, Canberra Hospital (Desmond Yip)
  • Footscray, Western Hospital (Footscray) (Lara Lipton)
  • Frankston, Frankston Hospital (Vinod Ganju)
  • Heidelberg 3084, Austin Repatriation Medical Centre (Heidelberg) (Niall Tebbutt)
  • Herston, Royal Brisbane And Women's Hospital (Herston) (David Wyld)
  • Hobart, Royal Hobart Hospital (Rosemary Young)
  • Launceston, Launceston General Hospital (Ian Byard)
  • Liverpool BC, Liverpool Hospital (Australia) (Patricia Kho)
  • Melbourne, St. Vincent's Hospital (Victoria) (Anthony Dowling)
  • Nedlands, Sir Charles Gairdner Hospital (Nedlands) (Guy Van Hazel)
  • Newcastle, Newcastle Mater Hospital (Stephen Ackland)
  • Penrith, Nepean Hospital (Penrith) (Jennifer Shannon)
  • Prahan, The Alfred Hospital (Victoria) (Jeremy Shapiro)
  • Randwick 2031, Prince Of Wales Hospital (Randwick) (David Goldstein)
  • South Toowoomba, Toowoomba Base Hospital (Ehtesham Abdi)
  • Sydney, Royal North Shore Hospital (Sydney) (Nick Pavlakis)
  • Sydney, Sydney Haematology & Oncology Centre (Gavin Marx)
  • Tweed Heads, The Tweed Hospital (Tweed Heads) (Ehtesham Abdi)
  • Wodonga, Border Medical Oncology (Christopher Steer)

CANADA

  • Edmonton, Cross Cancer Institute (Edmonton) (Andrew Scarfe)
  • Greenfield Park, Charles Le Moyne Hospital (Quebec) (Eric Bergeron)
  • Halifax, Nova Scotia Cancer Centre (Halifax) (Daniel Rayson)
  • Kelowna, BC Cancer Agency Centre For The Southern Interior (Kelowna) (Sanjay Chandar Rao)
  • Kingston, Kingston Regional Cancer Centre (Anna Tomiak)
  • London, London Regional Cancer Centre (Ontario) (Walter Kocha)
  • Montreal, Jewish General Hospital (Montreal) (Wilson Miller)
  • Montreal, McGill University (Montreal) (Wilson Miller)
  • Montreal, Royal Victoria Hospital (Quebec) (Wilson Miller)
  • Ottawa, Ottawa Regional Cancer Centre (Derek Jonker)
  • Toronto, Princess Margaret Hospital (Toronto) (Malcolm Moore)
  • Toronto, St. Joseph's Health Centre (Toronto) (John Blondal)
  • Toronto, Toronto-Sunnybrook Regional Cancer Centre (Scott Berry)
  • Victoria, BC Cancer Agency Vancouver Island Centre (Victoria) (Vanessa Bernstein)
  • Winnipeg, CancerCare Manitoba (Winnipeg) (Ralph Wong)

CZECH REPUBLIC

  • 140 21 Praha 4, IKEM (Miroslav Ryska)

FINLAND

  • Tampere, Tampere University Hospital (Juhani Sand)

FRANCE

  • 14033 Caen CEDEX, CHU Cote De Nacre (Caen) (Laurence Chiche)
  • 56000 Vannes, Centre Hospitalier Bretagne Atlantique (Vannes) (Didier Rio)
  • 59037 Lille CEDEX, Hopital Claude Huriez (Lille) (Christophe Mariette)
  • 59160 Lomme, Hopital St Philibert (Lomme) (Bertrand Nunes)
  • 74203 Thonon Les Bains, Hopital Georges Pianta (Thonon Les Bains) (Christian Dilin)
  • 75014 Paris, Hopital Cochin (Paris) (Bertrand Dousset)
  • 75020 Paris, Hopital Tenon (Paris) (François Lacaine)
  • 78300 Poissy, Hopital De Poissy (Abe Fingerhut)
  • 80054 Amiens CEDEX 1, Hopital Nord (Amiens) (Jean-Marc Regimbeau)
  • 92700 Colombes, Hopital Louis Mourier (Colombes) (Simon Msika)
  • 93 140 Bondy, Jean Verdier (Bondy) (Gérard Champault)
  • 93602 Aulnay-sous-Bois, Hopital Robert Ballanger (Aulnay-sous-Bois) (André Elhadad)
  • 94 190 Villeneuve-St-Georges, CHI Villeneuve St Georges (Jean-Manuel Gruss)
  • 95303 Cergy Pontoise CEDEX, Hopital Rene Dubos (Cergy Pontoise) (Lionel Charre)
  • 95602 Eaubonne CEDEX, Hopital Simone Veil (Eaubonne) (Said Sbai-Idrissi)

GERMANY

  • 04103 Leipzig, Universitatsklinikum Leipzig (Joachim Mössner)
  • 20148 Hamburg, Praxis Rothenbaum (Hamburg) (Rainer Klapdor)
  • 45122 Essen, University Hospital Essen (Andreas Paul)
  • 61920 Heidelberg, University Hospital Of Heidelberg (Markus Buchler)
  • 66421 Homburg, University Of Saarland (Jochen Rädle)
  • 70376 Stuttgart, Robert-Bosch-Krankenhaus (Stuttgart) (Walter Erich Aulitzky)
  • 89075 Ulm, University Of Ulm (Gerhard Leder)
  • D - 17487 Greifswald, Ernst-Moritz-Arndt Universitat Greifswald (Markus Lerch)
  • D-20246 Hamburg, UKE Hamburg (Jakob Izbicki)
  • D-44791 Bochum, St. Josef Hospital (Bochum) (Ansgar Chromik)
  • D-81675 Munchen, Klinikum Rechts Der Isar Der TU Munchen (Jörg Kleeff)
  • Friedrich-Pattreth-Strase 100, Reinhard-Nieter-Krankenhaus (Marcus Schmitt)
  • Ludwigsburg, Klinikum Ludwigsburg (Peter Frühmorgen)

GREECE

  • 54634 Thessaloniki, Agios Dimitrios General Hospital (Thessaloniki) (Eftimios Chatzitheoklitos)
  • Athens 14233, Agia Olga Hospital (Christos Dervenis)
  • Thessaloniki, Papageorgiou General Hospital (Thessaloniki) (Eftimios Chatzitheoklitos)

HUNGARY

  • H7643 Pecs, Medical Faculty Of Pecs University (Dezsö Kelemen)
  • H-9002 Gyor, Petz Aladar County Hospital (Gyor) (Attila Olah)

IRELAND

  • Dublin 8, St. James's Hospital (Dublin) (Ken O'Byrne)
  • Dublin 9, Beaumont Hospital (Dublin) (Liam Grogan)

ITALY

  • 35128 Padova, Castelfranco Veneto (Padova) (Sergio Pedrazzoli)
  • 35128 Padova, Universita Degli Studi Di Padova (Sergio Pedrazzoli)
  • 37134 Verona, Policlinico Borgo Roma (Verona) (Claudio Bassi)

JAPAN

  • , Osaka National Cancer Centre (Masaki Kashiwazaki)
  • , Tohuko University Hospital (Makoto Sunamura)
  • Chiba 260-8717, Chiba Cancer Centre (Takehide Asano)
  • Fukouka 811-1395, National Kyushu Cancer Centre (Fukuoka) (Akihiro Funakoshi)
  • Fukuoka 812-8582, Kyushu University Hospital (Fukuoka) (Akihiro Funakoshi)
  • Kyoto 606-8507, Kyoto University Hospital (Masayuki Imamura)
  • Tokyo 162-, Tokyo Womens Medical University (Ken Takasaki)

NEW ZEALAND

  • Christchurch, Christchurch Hospital (Bridget Robinson)

POLAND

  • 20-081 Lublin, Medical University In Lublin (Wojciech Polkowski)

SERBIA

  • 11000 Belgrade, First Surgical Clinic CCS (Belgrade) (Miroslav Milicevic)

SWEDEN

  • 413 45 Göteborg, Sahlgrenska Universitetssjukhusetmore (Goteborg) (Mikael Johansson)
  • 581 85 Linköping, Universitetssjukhuset i Linkoping (Charlotte Bratthäll)
  • S-901 85 Umeå, Norrlands Universitetssjukhus (Umea) (Peter Naredi)
  • SE-118 83 Stockholm, Stockholm Soder Hospital (Pehr Lind)
  • SE-141 86 Stockholm, Huddinge University Hospital (Stockholm) (Pehr Lind)
  • SE-171 76 Stockholm, Radiumhemmet Karolinska Hospital (Stockholm) (Bengt Glimelius)
  • SE-751 85 Uppsala, Akademiska Sjukhuset (Uppsala) (Peter Nygren)
  • SE-751 85 Uppsala, Akademiska Sjukhuset (Uppsala) [previously listed as Uppsala Uni Hosp] (Bengt Glimelius)

SWITZERLAND

  • 3010 Bern, Inselspital Hospital Bern (Beat Gloor)

UK: ENGLAND

  • Ashington, Wansbeck General Hospital (Ashington) (Paula Mulvenna)
  • Barnstaple, North Devon District Hospital (Barnstaple) (Mark Napier)
  • Birmingham, Queen Elizabeth Hospital (Birmingham) (John Buckels)
  • Bristol, Bristol Haematology and Oncology Centre (Stephen Falk)
  • Cambridge, Addenbrooke's NHS Trust (Pippa Corrie)
  • Chelmsford, Broomfield Hospital (Saad Tahir)
  • Derby, Royal Derby Hospital (Rajendra Kulkarni)
  • Dudley, Russells Hall Hospital (Dudley) (David Ferry)
  • Durham, University Hospital of North Durham (Fareeda Coxon)
  • Exeter, Royal Devon & Exeter Hospital (Elizabeth Toy)
  • Great Yarmouth, James Paget Hospital (Great Yarmouth) (Ulrike Dernedde)
  • Guildford, St. Luke's Cancer Centre (Guildford) (Sebastian Cummins)
  • Huddersfield, Huddersfield Royal Infirmary (Jo Dent)
  • Kingston Upon Hull, The Princess Royal Hospital (Hull) [Demolished] (Anthony Maraveyas)
  • Leeds, Cookridge Hospital [Now St James's UH] (Leeds) (Alan Anthoney)
  • Leicester, Leicester Royal Infirmary (Will Steward)
  • Liverpool, Royal Liverpool University Hospital (David Smith)
  • Liverpool, Royal Liverpool University Hospital (Daniel Palmer)
  • Liverpool, Whiston Hospital (Liverpool) (Ernie Marshall)
  • London, Guy's Hospital (London) (Paul Ross)
  • London, Hammersmith Hospital (London) (Harpreet Wasan)
  • London, Middlesex Hospital (London) (John Bridgewater)
  • London, Royal Free Hospital (London) (Tim Meyer)
  • London, Royal Marsden Hospital (London) (David Cunningham)
  • London, St. Bartholomew's Hospital (London) (David Propper)
  • London, St. George's Hospital (London) (Fiona Lofts)
  • London, University College London (Jonathan Ledermann)
  • Maidstone, Maidstone Hospital (Mark Hill)
  • Middlesbrough, James Cook University Hospital (Middlesbrough) (Nick Wadd)
  • Newcastle upon Tyne, Newcastle General Hospital (Now Freeman Hospital) (Fareeda Coxon)
  • Norwich, Norfolk and Norwich University Hospital (Jenny Nobes)
  • Nottingham, Nottingham City Hospital (Srinivasan Madhusudan)
  • Oxford, Churchill Hospital (Oxford) (Mark Middleton)
  • Peterborough, Peterborough City Hospital (Karen McAdam)
  • Plymouth, Derriford Hospital (Plymouth) (Sarah Pascoe)
  • Poole, Poole General Hospital (Richard Osborne)
  • Portsmouth, Portsmouth Oncology Centre (Caroline Archer)
  • Sheffield, Weston Park Hospital (Sheffield) (Jonathan Wadsley)
  • Southampton, Royal South Hants Hospital (Southampton) (Christopher Baughan)
  • Southampton, Southampton General Hospital (Tim Iveson)
  • Stafford, Staffordshire General Hospital (now Stafford Hospital) (Fawzi Adab)
  • Stoke-on-Trent, University Hospital of North Staffordshire (Arshad Jamil)
  • Sunderland, Sunderland Royal Hospital (Ashraf Azzabi)
  • Sutton, Royal Marsden Hospital (Sutton) (David Cunningham)
  • Torquay, Torbay District General Hospital (Torquay) (Elizabeth Toy)
  • Walsgrave, Walsgrave Hospital (Sharmila Sothi)
  • Westcliff-on-Sea, Southend Hospital (Westcliff-on-Sea) (Pauline Leonard)
  • Wirral, The Clatterbridge Cancer Centre (Wirral) (Daniel Palmer)
  • Wolverhampton, New Cross Hospital (Wolverhampton) (Mark Churn)
  • Yeovil, Yeovil District Hospital (Julie Walther)

UK: N. IRELAND

  • Belfast, Belfast City Hospital (Martin Eatock)

UK: SCOTLAND

  • Dundee, Ninewells Hospital (Dundee) (Douglas Adamson)
  • Edinburgh, Royal Infirmary of Edinburgh (Lucy Wall)
  • Edinburgh, Western General Hospital (Edinburgh) (Lucy Wall)
  • Glasgow, Glasgow Royal Infirmary (Colin McKay)
  • Glasgow, The Beatson West of Scotland Cancer Centre (Glasgow) (Adnan Arif Shaukat)

UK: WALES

  • Cardiff, Velindre Hospital (Cardiff) (Tom Crosby)
  • Swansea, Singleton Hospital (Swansea) (Colin Askill)
  • Wrexham, Wrexham Maelor Hospital (Simon Gollins)

Links  

../docs/Protocols/ESPAC-3_Protocol.pdf#ESPAC-3(v2) Protocol