Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
15/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

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 measures

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

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

http://www.cancer.org.uk

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

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes