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

ISRCTN ISRCTN73941125
DOI https://doi.org/10.1186/ISRCTN73941125
Secondary identifying numbers RMH E/C 1323
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
19/02/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr - -
Scientific

UKCCCR
Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Phone +44 (0) 20 7670 4723

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBiliary Tract
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Cancer drugs
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2000
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2000
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR
London
NW1 2DA
United Kingdom

Sponsor information

The Royal Marsden NHS Foundation Trust (UK)
Hospital/treatment centre

Downs Road
Sutton
SM2 5PT
England
United Kingdom

ROR logo "ROR" https://ror.org/0008wzh48

Funders

Funder type

Research organisation

Royal Marsden Hospital (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 09/05/2005 Yes No