| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN73941125 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | RMH E/C 1323 |
| Public title | A Randomised trial comparing epirubicin, cisplatin and protracted venous infusion (PVI) 5-Fluorouracil (5FU) (ECF) to 5FU, Etoposide Leucovorin (FELU) in patients with inoperable or metastatic biliary cancer |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Biliary Tract |
| 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 locally advanced or metastatic adenocarcinoma, squamous carcinoma or undifferentiated carcinoma of the gallbladder, intra/extra-hepatic bile ducts or Ampulla of valter
2. Measurable disease on Computed Tomography (CT), Magnetic Resonance Imaging (MRI) or radiograph |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Two Arms:
1. FELU: 5FU 600 mg/m2 IV bolus 1-3 every 3 weeks Etoposide 120 mg/m2 IV infusion over 40 min days 1-3 every 3 weeks Leucovorin 60 mg/m2 IV bolus days 1-3 every 3 weeks
2. ECF: 5FU 200 mg/m2 daily continuous infusion for 24 weeks. Epirubicin 50 mg/m2 3-weekly IV bolus Cisplatin 60 mg/m2 3 weekly |
| 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 UKCCCR Register Co-ordinator |
| Contact details | 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 | ISRCTN73941125 |
| Date last extracted from ISRCTN register | 17/04/2008 |
