Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00058201
Protocol/serial number
ESPAC-3
Study information
Scientific title
Acronym
ESPAC-3
Study hypothesis
Not provided at time of registration
Please note that as of 03/09/09 the ethics and primary outcomes of this trial were updated. The end date of this trial was also extended from 01/12/2005 to 07/05/2008
Ethics approval
Added 03/09/09: Received from local medical ethics committee (MREC ref: 99/8/74)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pancreatic cancer
Intervention
1. 5-FU and Folinic Acid: Folinic Acid D-L form: 20 mg/m2 iv bolus injection followed by 5-FU: 425 mg/m2 iv bolus injection given on 5 consecutive days every 28 days for six cycles (24 weeks)
2. Gemcitabine: 1000 mg/m2 given as iv infusion over 30 min once a week for 3 of every 4 weeks for six cycles (24 weeks)
3. No adjuvant
Intervention type
Drug
Phase
Phase III
Drug names
5-Fluorouracil (5FU), D-L-folinic acid, gemcitabine
Primary outcome measure
Added 03/09/09:
1. Survival at 2 and 5 years
2. Toxicity
3. Quality of life
4. Relapse free survival
Secondary outcome measures
Not provided at time of registration
Overall trial start date
03/07/2000
Overall trial end date
07/05/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1.1. Patients who have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas
1.2. 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 World Health Organisation (WHO) performance status ≤2
6. Fully recovered from surgery and fit to take part in the trial. Life expectancy of more 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
03/07/2000
Recruitment end date
07/05/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20823433
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22782416
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24301456
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24419109
Publication citations
-
Results
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, , Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial., JAMA, 2010, 304, 10, 1073-1081, doi: 10.1001/jama.2010.1275.
-
Results
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, , 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, doi: 10.1001/jama.2012.7352.
-
Results
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, Scarpa A, Bassi C, Büchler MW, , Pancreatic cancer hENT1 expression and survival from gemcitabine in patients from the ESPAC-3 trial., J. Natl. Cancer Inst., 2014, 106, 1, djt347, doi: 10.1093/jnci/djt347.
-
Results
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., J. Clin. Oncol., 2014, 32, 6, 504-512, doi: 10.1200/JCO.2013.50.7657.