| Source of record | UK Trials |
| ISRCTN | ISRCTN37494643 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | ESPAC-3 |
| Public title | Phase III adjuvant trial in pancreatic cancer comparing 5-Fluorouracil (5FU) and D-L-folinic acid versus gemcitabine versus no adjuvant treatment |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Pancreas |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 03/07/2000 |
| Anticipated end date | 01/12/2005 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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 |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN37494643 |
| Date last extracted from ISRCTN register | 17/04/2008 |
