Condition category
Cancer
Date applied
15/02/2005
Date assigned
21/03/2005
Last edited
09/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr John Bridgewater

ORCID ID

Contact details

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

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

Publication citations

Additional files

Editorial Notes