ESPAC 3 Study

Phase III adjuvant trial in pancreatic cancer comparing: 5- fluorouracil + D-L folinic acid with gemcitabine or no adjuvant treatment.

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Trial Status

Completed

Cancer Type

Pancreatic Cancer

Aim

Surgery is the best treatment for cancers of the pancreas that have not spread further. However, despite the best surgery, the cancer often comes back. This trial will determine if chemotherapy given after surgery can prevent or delay cancer recurrence and its effects on quality of life.

Summary

  • Most current version of protocol is V10, 20August2008 distributed to the sites on 9th July that still have patients on follow-up. So far we have received HREC approval for protocol amendment from 12 There are still 6 more sites to follow up.
  • Recruitment to Ductal Arm patients ceased in December 2006 on reaching the target accrual number of 1030. 30 additional patients were also recruited to this arm to compensate for study patients with no data.
  • 300th Ampullary arm patient was recruited to ESPAC-3(v2) on 16 April 2008 therefore reaching its target recruitment
  • ESPAC T-Plus – Tissue Banking sub protocol. AGITG received HREC approval in March Study sites were requested in May 2008 to submit tissue banking informed consents forms to local HRECs for approval and then offer the PICFS to the patients that are still alive.
  • 11 sites have finalised their Tissue Banking PICFs and submitted to their HREC for approval. 8 Sites have received
  • Progress of ESPAC3 T-plus tissue banking start up/submission package is being followed-up with .
  • Retrospective collection of tissue blocks for patients in progress
  • Database closed for analysis on 17th July 2009

Trial Status

Completed

Cancer Type

Pancreatic Cancer

Publication Reference

  1. Neoptolemos JP, Stocken DD, Bassi C, Ghaneh P, Cunningham D, Goldstein D, Padbury R, Moore MJ, Gallinger S, Mariette C, Wente MN, Izbicki JR, Friess H, Lerch MM, Dervenis C, Oláh A, Butturini G, Doi R, Lind PA, Smith D, Valle JW, Palmer DH, Buckels JA, Thompson J, McKay CJ, Rawcliffe CL, Büchler, MW; for the European Study Group for Pancreatic Cancer. Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial. JAMA.2010; 304(10): 1073–1081.
  2. Greenhalf W, Ghaneh P, Neoptolemos JP, Palmer DH, Cox TF, Lamb RF, Garner E, Campbell F, Mackey JR, Costello E, Moore MJ, Valle JW, McDonald AC, Carter R, Tebbutt NC, Goldstein D, Shannon J, Dervenis C, Glimelius B, Deakin M, Charnley RM, Lacaine F, Scarfe AG, Middleton MR, Anthoney A, Halloran CM, Mayerle J, Oláh A, Jackson R, Rawcliffe CL, Scarpe A, Bassi C, Büchler MW, and for the European Study Group for Pancreatic Cancer. Pancreatic cancer hENT1 expression and survival from gemcitabine in patients from the ESPAC-3 trial. Journal of the National Cancer Institute 2014; 106(1): djt347.
  3. Valle JW, Palmer D, Jackson R, Cox T, Neoptolemos JP, Ghaneh P, Rawcliffe CL, Bassi C, Stocken DD, Cunningham D, O’Reilly D, Goldstein D, Robinson BA, Karapetis C, Scarfe A, Lacaine F, Sand J, Izbicki JR, Mayerle J, Dervenis C, Oláh A, Butturini G, Lind PA, Middleton MR, Anthoney A, Sumpter K, Carter R, Büchler MW. Optimal duration and timing of adjuvant chemotherapy after definitive surgery for ductal adenocarcinoma of the pancreas: ongoing lessons from the ESPAC-3 study. Journal of Clinical Oncology 2014; 32(6): 504–512.
  4. Neoptolemos JP, Moore MJ, Cox TF, Valle JW, Palmer DH, McDonald AC, Carter R, Tebbutt NC, Dervenis C, Smith D, Glimelius B, Charnley RM, Lacaine F, Scarfe AG, Middleton MR, Anthoney A, Ghaneh P, Halloran CM, Lerch MM, Oláh A, Rawcliffe CL, Verbeke CS, Campbell F, Büchler MW, European Study Group for Pancreatic Cancer. Effect of adjuvant chemotherapy with fluorouracil plus folinic acid or gemcitabine vs observation on survival in patients with resected periampullary adenocarcinoma: the ESPAC-3 periampullary cancer randomized trial. JAMA 2012; 308(2): 147–156.

Conference Presentation Reference

  1. Neoptolemos J, Greenhalf W, Ghaneh P, Palmer D, Cox T, Garner E, Campbell F, Mackey J, Moore M, Valle J, Mcdonald A, Tebbutt N, Darvenos C, Glimelius B, Charnley R, Lacaine F, Mayerle J, Rawcliffe L, Bassi C, Buchler M, European Study Group for Pancreatic Cancer. HENT1 tumor levels to predict survival of pancreatic ductal adenocarcinoma patients who received adjuvant gemcitabine and adjuvant 5FU on the ESPAC trials. American Society of Clinical Oncology Annual Meeting; 31 May–4 Jun 2013; Chicago.
  2. Neoptolemos JP, Moore MJ, Cox TF, Valle JW, Palmer DH, McDonald A, Carter R, Tebbutt NC, Dervenis C, Smith D, Glimelius B, Coxon FY, Lacaine F, Middleton R, Ghaneh P, Bassi C, Halloran C, Olah A, Rawcliffe CL, Büchler MW, European Study Group for Pancreatic Cancer. Ampullary cancer ESPAC-3 (v2) trial: A multicenter, international, open-label, randomized controlled phase III trial of adjuvant chemotherapy versus observation in patients with adenocarcinoma of the ampulla of Vater. American Society of Clinical Oncology Annual Meeting; 4–8 Jun 2011; Chicago. Journal of Clinical Oncology 2011; 29 (suppl.). Abstract LBA4006.
  3. Neoptolemos J, Büchler M, Stocken DD, Ghaneh P, Smith D, Bassi C, Moore M, Cunningham D, Dervenis C, Goldstein D. ESPAC-3(v2): a multicentre, international, open label, randomised controlled phase III trial of adjuvant 5-fluorouracil/folinic acid versus gemcitabine in patients with resected pancreatic ductal adenocarcinoma. Annual Meeting of the American Society of Clinical Oncology; 29 May–2 Jun 2009; Orlando. Journal of Clinical Oncology 2009; 27: 18s. Abstract LBA4505.
  4. Padbury R, Goldstein D, Knight E, Dhillon H, Tebbutt N, Yip S, Simes J. Continuation of an adjuvant therapy trial in the light of new evidence: revised design of the European Study Group for Pancreatic Cancer 3 trial (ESPAC-3). Clinical Oncological Society of Australia 30th Annual Scientific Meeting; 25–28 Nov 2003; Perth.

Aim

Surgery is the best treatment for cancers of the pancreas that have not spread further. However, despite the best surgery, the cancer often comes back. This trial will determine if chemotherapy given after surgery can prevent or delay cancer recurrence and its effects on quality of life.

Summary

  • Most current version of protocol is V10, 20August2008 distributed to the sites on 9th July that still have patients on follow-up. So far we have received HREC approval for protocol amendment from 12 There are still 6 more sites to follow up.
  • Recruitment to Ductal Arm patients ceased in December 2006 on reaching the target accrual number of 1030. 30 additional patients were also recruited to this arm to compensate for study patients with no data.
  • 300th Ampullary arm patient was recruited to ESPAC-3(v2) on 16 April 2008 therefore reaching its target recruitment
  • ESPAC T-Plus – Tissue Banking sub protocol. AGITG received HREC approval in March Study sites were requested in May 2008 to submit tissue banking informed consents forms to local HRECs for approval and then offer the PICFS to the patients that are still alive.
  • 11 sites have finalised their Tissue Banking PICFs and submitted to their HREC for approval. 8 Sites have received
  • Progress of ESPAC3 T-plus tissue banking start up/submission package is being followed-up with .
  • Retrospective collection of tissue blocks for patients in progress
  • Database closed for analysis on 17th July 2009

Principal Investigator

Dr Rob Padbury & Prof David Goldstein