| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN54728875 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | PANCRAD |
| Public title | A Randomised Trial of CF (Infusional 5-Fluorouracil and Cisplatin) Alone versus CF Plus Concurrent Radiotherapy in Patients with Locally Advanced Pancreatic Carcinoma |
| 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 | 1. Histological evidence of locally advanced or unresectable pancreatic adenocarcinoma
2. Patients evaluable for response must have bidmensionally measurable disease as assessed by Computed Tomography (CT) scans
3. No prior chemotherapy or radiotherapy
4. Life expectancy of >3 months
5. Adequate bone marrow and renal function
6. World Health Organisation (WHO) performance status 0-2 at randomisation
7. No medical contraindications to treatment protocols |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 11/11/1994 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 1. Regimen A: 5-fluorouracil, continuous infusion for 18 weeks, plus cisplatin repeated every 3 weeks for six cycles.
2. Regimen B: Cisplatin repeated every 3 weeks for four cycles plus 5-fluorouracil, continuous infusion for 12 weeks followed by continuous infusion for a further 6 weeks at a reduced dose. Radiotherapy 50 Gy in twenty-five fractions given over 5 weeks. Radiotherapy to commence on week 13 of chemotherapy. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Royal Marsden Hospital |
| Sponsor name | Royal Marsden Hospital (UK) |
| Sponsor details | Downs Road
Sutton
United Kingdom
SM2 5PT |
| Sponsor telephone | +44 (0)20 8661 3156 |
| Sponsor fax | +44 (0)20 8643 9414 |
| Sponsor website | david.cunningham@rmh.nhs.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 | ISRCTN54728875 |
| Date last extracted from ISRCTN register | 17/04/2008 |
