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Phase III Adjuvant Trial in Pancreatic Cancer Comparing 5FU and D-L-Folinic Acid vs. Gemcitabine

Portfolio Eligibility
Automatically eligible
ISRCTN 37494643
MREC N° 99/8/74
Research Summary
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%. There was some evidence from the GITSG study (43 patients) that adjuvant chemoradiation may help to improve these results but the EORTC trial (114 patients)did not show any advantage. Studies from Norway (61 patients) and Japan (158 patients) also failed to show a long-term survival benefit for adjuvant chemotherapy. ESPAC-1 was designed to further investigate the role of chemoradiotherapy and adjuvant 5FU/folinic acid following resection. By April 2000, 596 patients had been randomised into ESPAC-1 and a preliminary analysis showed no survival benefit for chemoradiotherapy but a possible survival benefit for chemotherapy, irrespective of histologically positive resection margins. A final analysis Of ESPAC-1 (June 2003) of 550 patients with pancreatic ductal adenocarcinoma not only confirmed the lack of benefit of chemoradiotherapy but also demonstrated a clear survival benefit for chemotherapy. Thus the future of adjuvant treatment lies with more effective systemic therapy and necessitated removal of the „surgery alone? arm from the original ESPAC-3 trial for patients with pancreatic ductal adenocarcinoma of the pancreas (approved protocol version February 2003). ESPAC-3(v2) will therefore test the promising new agent gemcitabine against the chemotherapy arm from ESPAC-1, 5FU/ folinic acid. Patients with ampullary or other pancreatic tumours will continue to be randomised between the two chemotherapy arms plus surgery alone, until any evidence emerges that chemotherapy is of significant benefit in this group also.
Study Type Interventional
Design Type Treatment
Disease(s) Pancreas
Phase III
Current Status Closed - in follow-up
Closure Date 5/7/2008
Global Sample Size 1583
Global Recruitment to Date
Geographical Scope International Multi-Centre
Lead Country England (also active in Scotland and Northern Ireland and Wales)
Health care professionals can obtain a copy of the protocol by clicking here
Study Website
Additional Information

ESPAC-3(v2) is a modification of ESPAC-3, not a new trial. Details of the sponsors' roles for this trial are yet to be finalised. If you are a patient or relative this link will take you to a description of this trial in plain English on CancerHelp UK

Main Inclusion Criteria
1a) Patients who have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas
1b) Patients with other cancer may be included who have had complete macroscopic resection for unusual malignancies of the pancreas; cancer of the periampullary region; cancer of the intra-pancreatic bile duct; periampullary cancer of uncertain origin.
2) Histological confirmation of the primary diagnosis
3) Histological examination of all resection margins
4) No evidence of malignant ascites, liver metastases, spread to other distant abdominal organs, peritoneal metastases, spread to extra-abdominal regions
5) A WHO performance status less than or equal to 2
6) Fully recovered from surgery and fit to take part in the trial. Life expectancy of more e than 3 months
7) Able to attend for administration of adjuvant therapy
8) Able to attend for long-term follow-up
9) No previous or concurrent malignancy diagnoses
10) No serious medical or psychological condition precluding adjuvant treatment
11) Fully informed written consent given
Main Exclusion Criteria
1) Use od neo-adjuvant chemotherapy or other concomitant chemotherapy.
2) Patients with pancreatic lymphoma
3) Macroscopically remaining tumour (R2 resection).
4) Patients with TNM Stage IVb disease
5) Patients younger than 18 years
6) Pregnancy.
Chief Investigator(s)
Prof John Neoptolemos
Further details, please contact
Mr Karl Harvey

University of Liverpool
Cancer Research UK Liverpool Cancer Trials Unit
200 London Road
L3 9TA

Tel: 0151 794 8932
Fax: 0151 794 8247
Miss Charlotte Rawcliffe

University of Liverpool
Cancer Research UK Liverpool Cancer Trials Unit
200 London Road
L3 9TA

Tel: 0151 7948932
Funder(s) Cancer Research UK
Sponsor(s) University of Liverpool
Royal Liverpool and Broadgreen University Hospitals NHS Trust
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