Plain English Summary
Trial website
Additional identifiers
EudraCT number
2004-004882-14
ClinicalTrials.gov number
NCT00262769
Protocol/serial number
N/A
Study information
Scientific title
Gemcitabine, alone or in combination with cisplatin, in patients with advanced or metastatic cholangiocarcinomas and other biliary tract tumours: a multicentre, randomised, phase III study
Acronym
ABC-02
Study hypothesis
The aim of this trial is to compare gemcitabine alone to gemcitabine and cisplatin, in patients with advanced or metastatic biliary tract tumours, in order to establish a standard treatment. This is a multicentre, randomised, phase III trial, designed by members of the Trial Management Group in consultation with the National Cancer Research Institute (NCRI) Upper Gastrointestinal Clinical Studies Group.
Ethics approval
No ethics information provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Advanced or metastatic biliary tract carcinoma
Intervention
Randomisation between:
Arm A: Gemcitabine 1000 mg/m^2 intravenous (IV) infusion on days one, eight and 15 of each 28 day cycle (six cycles in total)
Arm B: Gemcitabine 1000 mg/m^2 and Cisplatin 25 mg/m^2 IV infusion on days one and eight of each 21 day cycle (eight cycles in total)
Intervention type
Drug
Phase
Phase III
Drug names
Gemcitabine, cisplatin
Primary outcome measures
The primary objective of this trial is to determine whether the overall survival of patients treated with gemcitabine compared with patients treated with gemcitabine and cisplatin in biliary tract cancer.
Secondary outcome measures
The secondary objective is to determine the progression-free survival, toxicity and quality of life of patients treated with gemcitabine compared with patients treated with gemcitabine and cisplatin in biliary tract cancer.
Overall trial start date
01/03/2005
Overall trial end date
31/03/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Over 16 years of age
2. Histologically/cytologically confirmed biliary tract carcinoma
3. Unsuitable for surgery
4. Adequate renal, haematological and liver function
5. Adequate biliary drainage
6. Eastern Cooperative Oncology Group (ECOG) performance score of zero, one or two
7. Life expectancy of greater than 12 weeks
8. Patient consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
1. No concurrent treatment for metastatic disease
2. Other/prior malignancy or intercurrent disease precluding trial entry
3. Pregnancy/lactation
4. Unable to give consent
NB. Patients with impaired hearing must be made aware of potential ototoxicity
Recruitment start date
01/03/2005
Recruitment end date
31/03/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Free & University College Medical School
London
W1W 7BS
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
Stephenson House
158-160 North Gower Street
London
NW1 2ND
United Kingdom
-
f.owen@ctc.ucl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Clinical Trials Advisory and Awards Committee (CTAAC) Ref: C1813/A4853
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
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20375404