Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
19/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR
Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
+44 (0) 20 7670 4723

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

Sponsor information

Organisation

The Royal Marsden NHS Foundation Trust (UK)

Sponsor details

Downs Road
Sutton
SM2 5PT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes