Phase III adjuvant trial in pancreatic cancer comparing 5-Fluorouracil (5FU) and D-L-folinic acid versus gemcitabine versus no adjuvant treatment

ISRCTN	ISRCTN37494643
DOI	https://doi.org/10.1186/ISRCTN37494643
ClinicalTrials.gov number	NCT00058201
Secondary identifying numbers	ESPAC-3

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Phase III adjuvant trial in pancreatic cancer comparing 5-Fluorouracil (5FU) and D-L-folinic acid versus gemcitabine versus no adjuvant treatment
Study acronym	ESPAC-3
Study objectives	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(s)	Added 03/09/09: Received from local medical ethics committee (MREC ref: 99/8/74)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	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 study start date	03/07/2000
Completion date	07/05/2008

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Not provided at time of registration
Key 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
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	03/07/2000
Date of final enrolment	07/05/2008

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Charity

Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	08/09/2010		Yes	No
Results article	results	11/07/2012		Yes	No
Results article	results	01/01/2014		Yes	No
Results article	results	20/02/2014		Yes	No
Plain English results			28/10/2021	No	Yes

28/10/2021: Cancer Research UK plain English results link added.