Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RMH E/C 1323
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Biliary Tract
Intervention
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
Intervention type
Drug
Phase
Not Specified
Drug names
Cancer drugs
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2000
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant 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 Vater
2. Measurable disease on Computed Tomography (CT), Magnetic Resonance Imaging (MRI) or radiograph
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2000
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR
London
NW1 2DA
United Kingdom
Funders
Funder type
Research organisation
Funder name
Royal Marsden Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2005 results in: http://www.ncbi.nlm.nih.gov/pubmed/15856037
Publication citations
-
Results
Rao S, Cunningham D, Hawkins RE, Hill ME, Smith D, Daniel F, Ross PJ, Oates J, Norman AR, Phase III study of 5FU, etoposide and leucovorin (FELV) compared to epirubicin, cisplatin and 5FU (ECF) in previously untreated patients with advanced biliary cancer., Br. J. Cancer, 2005, 92, 9, 1650-1654, doi: 10.1038/sj.bjc.6602576.