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ESPAC-Tplus   

Title

A Translational Study, Characterisation of Tumour Molecular Response Predictors of Chemotherapy and Radiotherapy Treatments for Pancreatic Cancer in Patients in the ESPAC Trials


Basic Trial Information

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

Purpose

The ESPAC-1 trial has shown that pancreatic ductal adenocarcinoma is responsive to adjuvant chemotherapy (5FU). The ESPAC-1 trial has shown that pancreatic ductal adenocarcinoma is responsive to adjuvant chemotherapy (5FU). The ESPAC-3 trial is now comparing adjuvant 5-FU and gemcitabine.
ESPAC-TPlus was funded by the Translational Research in Clinical Trials Committee (TRICC) of Cancer Research UK in order to enable high quality translational research to be embedded in the ESPAC trials. ESPAC-TPlus is designed to allow both prospective and retrospective sample collection and analysis.
It is likely that some patients will respond better to adjuvant 5-FU than gemcitabine following resection for pancreatic ductal adenocarcinoma, while others will respond better to gemcitabine. Survival of an individual patient will therefore depend on which treatment they are given, but at present a clinician has very little information on which to base the choice of treatment.
Pancreatic tumours are highly characterised in molecular terms facilitating molecular taxonomy of these tumours and the identification of predictive therapeutic response molecular signatures. ESPAC-3 trial is now comparing adjuvant 5-FU and gemcitabine.


Trial Start Date

01/10/2007


Trial Coordinator

Chloe Smith


Trial Coordinator Email Address

chloe.smith@liv.ac.uk


Trial Coordinator Contact No

0151 794 8834


Website Treatment  

The ESPAC-Tplus trial will centralise collection and characterization of tissue, which will then be coded and linked with clinical outcome data. Tissue microarrays and matched samples will be sent out to the ESPAC centres for direct analyses of proteins known to be related to 5FU and gemcitabine resistance.
The project will ultimately enable specific treatments to be targeted to patients who are likely to respond with an improved survival.

Trial Endpoints  

The objective of ESPAC-TPlus is to identify markers in the primary tumour which predict improved probability of survival for either adjuvant 5-FU or gemcitabine following resection for pancreatic ductal adenocarcinoma.


Primary Outcome  


Secondary Outcomes  

Eligibility  

  • Samples collected from patients who have participated in the ESPAC-1 or ESPAC-3(v2) trial

AUSTRALIA

  • Adelaide, Flinders Medical Centre (Adelaide) (Christos Karapetis)
  • Adelaide, Royal Adelaide Hospital (Ian Olver)
  • Footscray, Western Hospital (Footscray) (Lara Lipton)
  • Hobart, Royal Hobart Hospital (Rosemary Young)
  • Randwick 2031, Prince Of Wales Hospital (Randwick) (David Goldstein)
  • Tweed Heads, The Tweed Hospital (Tweed Heads) (Ehtesham Abdi)

CANADA

  • Edmonton, Cross Cancer Institute (Edmonton) (Heather-Jane Au)
  • London, London Regional Cancer Centre (Ontario) (Ian Kerr)
  • Victoria, BC Cancer Agency Vancouver Island Centre (Victoria) (Brian Weinerman)

GERMANY

  • 61920 Heidelberg, University Hospital Of Heidelberg (Markus Buchler)
  • 89075 Ulm, University Of Ulm (Gerhard Leder)

JAPAN

  • Kyoto 606-8507, Kyoto University Hospital (Masayuki Imamura)

UK: ENGLAND

  • Birmingham, Queen Elizabeth Hospital (Birmingham) (Daniel Palmer)
  • Blackburn, Royal Blackburn Hospital (David Muskett)
  • Bradford, Bradford Royal Infirmary (Sue Cheeseman)
  • Bristol, Bristol Haematology and Oncology Centre (Stephen Falk)
  • Bristol, Bristol Royal Infirmary (Stephen Falk)
  • Cambridge, Addenbrooke's Hospital (Cambridge) (Pippa Corrie)
  • Chelmsford, Broomfield Hospital (Saad Tahir)
  • Derby, Derbyshire Royal Infirmary (Rajendra Kulkarni)
  • Deswbury, Dewsbury District Hospital (Kevin Birbeck)
  • Dudley, Russells Hall Hospital (Dudley) (David Ferry)
  • Guildford, St. Luke's Cancer Centre (Guildford) (Gary Middleton)
  • Hartshill, North Staffordshire Royal Infirmary (Victoria Smith)
  • Kingston Upon Hull, Princess Royal Hospital (Hull) (Anthony Maraveyas)
  • Leeds, Cookridge Hospital (Leeds) (Matt Seymour)
  • Leicester, Leicester Royal Infirmary (David Berry)
  • Liverpool, Royal Liverpool University Hospital (John Neoptolemos)
  • London, Hammersmith Hospital (London) (Harpreet Wasan)
  • London, King's College Hospital (London) (Bernard Portmann)
  • London, Royal Free Hospital (London) (Tim Meyer)
  • London, University College London (Jonathan Ledermann)
  • Maidstone, Maidstone Hospital (Mark Hill)
  • Manchester, Manchester Royal Infirmary (Ray McMahon)
  • Manchester, The Christie (Manchester) (Robert Hawkins)
  • Newcastle upon Tyne, Royal Victoria Infirmary (Newcastle) (Fareeda Coxon)
  • Norwich, Norfolk and Norwich University Hospital (Max Dahele)
  • Nottingham, Nottingham City Hospital (Srinivasan Madhusudan)
  • Oxford, Churchill Hospital (Oxford) (Mark Middleton)
  • Peterborough, Peterborough District Hospital (Karen McAdam)
  • Plymouth, Derriford Hospital (Plymouth) (Neil Robertson)
  • Poole, Poole General Hospital (Richard Osborne)
  • Portsmouth, St. Mary's Hospital (Portsmouth) (Caroline Archer)
  • Sheffield, Weston Park Hospital (Sheffield) (Jonathan Wadsley)
  • Southampton, Southampton General Hospital (Tim Iveson)
  • 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) (David Smith)
  • Wolverhampton, New Cross Hospital (Wolverhampton) (Mark Churn)

UK: N. IRELAND

  • Belfast, Belfast City Hospital (Martin Eatock)

UK: SCOTLAND

  • Dundee, Ninewells Hospital (Dundee) (Douglas Adamson)
  • Edinburgh, Western General Hospital (Edinburgh) (Lucy Wall)
  • Glasgow, Glasgow Royal Infirmary (Clem Imrie)

UK: WALES

  • Cardiff, Velindre Hospital (Cardiff) (Tim Maughan)
  • Rhyl, Glan Clwyd Hospital (Rhyl) (Simon Gollins)
  • Swansea, Morriston Hospital (Paul Griffiths)
  • Swansea, Singleton Hospital (Swansea) (Colin Askill)

Links  

../docs/Leaflets/ESPAC-Tplus.pdf#ESPAC-tplus leaflet