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ISRCTN
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ISRCTN37494643
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ClinicalTrials.gov identifier
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Public title
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Phase III adjuvant trial in pancreatic cancer comparing 5-Fluorouracil (5FU) and D-L-folinic acid versus gemcitabine versus no adjuvant treatment
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Scientific title
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Acronym
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N/A
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Serial number at source
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ESPAC-3
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Pancreas
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Participants - inclusion criteria
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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 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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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03/07/2000
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Anticipated end date
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01/12/2005
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cancer Research UK
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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21/11/2005
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Date ISRCTN assigned
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01/07/2001
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