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

ISRCTN	ISRCTN82956140
DOI	https://doi.org/10.1186/ISRCTN82956140
EudraCT/CTIS number	2004-004882-14
ClinicalTrials.gov number	NCT00262769
Secondary identifying numbers	N/A

Submission date: 15/02/2005
Registration date: 21/03/2005
Last edited: 19/10/2018

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

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-chemotherapy-for-advanced-cancer-of-the-bile-duct-or-gallbladder

Contact information

Dr John Bridgewater
Scientific

Royal Free & University College Medical School
Courtauld Building
91 Riding House Street
London
W1W 7BS
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	ABC-02
Study objectives	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(s)	No ethics information provided at time of registration.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Gemcitabine, cisplatin
Primary outcome measure	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 study start date	01/03/2005
Completion date	31/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	400
Key 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
Key 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
Date of first enrolment	01/03/2005
Date of final enrolment	31/03/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Free & University College Medical School

London
W1W 7BS
United Kingdom

Sponsor information

University College London (UK)
University/education

Stephenson House
158-160 North Gower Street
London
NW1 2ND
England
United Kingdom

Email	f.owen@ctc.ucl.ac.uk
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Research organisation

Clinical Trials Advisory and Awards Committee (CTAAC) Ref: C1813/A4853

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	08/04/2010		Yes	No

Editorial Notes

19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)