Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cancer of the biliary tract (gallbladder and bile duct) is a relatively rare form of cancer. The gall bladder is a small pouch which stores bile (a liquid essential for the breakdown of fats in the diet) made by the liver. Cancer of the gall bladder or bile duct that has spread and cannot be removed by an operation (inoperable) is often treated with chemotherapy. The aim of this study is to find out how effective a combination of two drugs, called capecitabine and oxaliplatin, is in treating these cancers as measured by shrinking the tumour on a CT scan. The study will also try to find out what side-effects are experienced by patients with these cancers when treated with this chemotherapy regimen.

Who can participate?
Adults with inoperable cancer of the gall bladder or bile duct.

What does the study involve?
Patients receive up to 6 cycles of chemotherapy. One cycle consists of capecitabine tablets given by mouth twice a day for 14 days. The oxaliplatin is given as a drip into a vein over 2 hours on the first day. This cycle of treatment is repeated every 3 weeks. A CT scan will be performed before starting treatment and then after 3 and 6 cycles of treatment to see what effect there has been on the size of the tumour.

What are the possible benefits and risks of participating?
There is a possibility that the treatment used in this study could help to shrink the tumour, however this is not certain. There is a risk that participants will experience side effects from the chemotherapy, including hair loss, sickness and vomiting, pain, tingling and numbness in the hands and feet, skin rash, blisters and peeling of the skin on the hands and feet, increased risk of infections which may be serious, or bruising.

Where is the study run from?
Five hospitals in Scotland, Ireland and the North of England (UK)

When is the study starting and how long is it expected to run for?
July 2003 to January 2006

Who is funding the study?
North Glasgow University Hospitals NHS Division (UK)

Who is the main contact?
Ms Eileen Soulis

Trial website

Contact information



Primary contact

Ms Eileen Soulis


Contact details

Clinical Trial Co-ordinator
Cancer Research UK Clinical Trials Unit
(partner in CaCTUS - Cancer Clinical Trials Unit Scotland)
Beatson West of Scotland Cancer Centre
Level 0
1053 Gt. Western Road
G12 0YN
United Kingdom
+44 (0) 141 301 7223

Additional identifiers

EudraCT number

2004-000928-32 number

Protocol/serial number


Study information

Scientific title

A phase II study of capecitabine and oxaliplatin combination chemotherapy in patients with inoperable adenocarcinoma of the gall bladder or biliary tract



Study hypothesis

The primary objective as stated in the study protocol is to determine the objective response rate (complete or partial), by the response evaluation criteria in solid tumours (RECIST) criteria, of capecitabine and oxaliplatin combination chemotherapy in patients with inoperable adenocarcinoma of the gall bladder or biliary tract.

Using an optimal two-stage Simon design, a total of 43 patients gives 80% power at the 5% significance level to detect a response rate of greater than or equal to 40%, at which point it would be appropriate to consider further studies with this regimen, from a response rate of 20%, below which this regimen would not be pursued in subsequent studies.

Ethics approval

West of Scotland REC 1, 15/05/2003, ref: MREC 03/8/027

Study design

Non-randomised interventional treatment trial

Primary study design


Secondary study design

Non randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: National Cancer Research Network; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Biliary Tract, Gall Bladder


1. Capecitabine, twice daily (BID) for 14 days every 21 days, 1000 mg/m^2
2. Oxaliplatin, once daily (OD) once every 21 days, 130 mg/m^2

Duration of treatment was 18 weeks (maximum of 6 cycles), duration of follow-up was until death or progression, or at the investigator's discretion.

Intervention type



Phase II

Drug names

Primary outcome measure

Objective response rate (complete and partial) by RECIST of capecitabine and oxaliplatin combination, assessed after 13 patients recruited.

Secondary outcome measures

Measured after 43 patients are recruited:
1. Toxicity
2. Progression-free survival
3. Overall survival

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Histologically or cytologically proven adenocarcinoma of the gall bladder or biliary tract
2. Inoperable disease as determined by radiological assessment, laparotomy or laparoscopy
3. At least one site of unidimensional measurable disease. Lesions must be at least 10 mm in diameter if measured on a spiral computed tomography (CT) scan.
4. Performance status greater than or equal to 2 (Eastern Cooperative Oncology Group [ECOG])
5. Adequate renal function (serum creatinine less than 1.5 x the upper limit of the normal reference range) and creatinine clearance greater than 50 ml/min as calculated by the Cockroft-Gault formula. Patients with creatinine clearance less than or equal to 50 mL/min by the Cockroft-Gault formula are eligible if the creatinine clearance is greater than 50 mL/min if measured by an EDTA assessment.
6. Written informed consent
7. Aged greater than 18 years, either sex
8. No prior chemotherapy for advanced disease
9. Able to reliably tolerate and comply with oral medication (capecitabine)

Participant type


Age group




Target number of participants

Planned sample size: 43

Participant exclusion criteria

1. Any evidence of uncontrolled cardiac disease or any other serious medical or psychiatric disorder that would be a contra-indication for prescribing this chemotherapy regimen
2. Pregnancy. Women of child-bearing potential not taking adequate contraception, and women who are breast feeding will also be excluded.
3. No prior or concurrent malignancy other than basal cell carcinoma of the skin or in situ neoplasia of the cervix uteri
4. Inadequate haematological function as defined by:
4.1. Haemoglobin (Hb) less than 10 g/dl
4.2. Neutrophil count less than 1.5 x 10^9/l
4.3. Platelets less than 100 x 10^9/l
5. Deranged liver function tests: serum bilirubin greater than 2.5 x upper limit of normal reference range for laboratory; transaminases greater than 5 x upper limit of normal reference range
6. Life expectancy less than 3 months
7. Any chemotherapy, radiotherapy, hormonal or immunotherapy within the last 4 weeks
8. Patients with a lack of physical integrity of the gastrointestinal (GI) tract leading to a malabsorption syndrome or intestinal obstruction that would impair administration or absorption of oral therapy
9. Patients with greater than grade 1 peripheral sensory neuropathy
10. Patients with known sensitivity to fluoropyrimidines or oxaliplatin

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Beatson West of Scotland Cancer Centre
Cancer Research UK Clinical Trials Unit (partner in CaCTUS - Cancer Clinical Trials Unit Scotland) Level 0 1053 Great Western Road
G12 0YN
United Kingdom

Trial participating centre

St James Hospital
James's St

Trial participating centre

Ninewells Hospital
United Kingdom

Trial participating centre

Western General Hospital
Crewe Road South
United Kingdom

Trial participating centre

Newcastle General Hospital
Westgate Road
Newcastle upon Tyne
United Kingdom

Sponsor information


NHS Greater Glasgow and Clyde

Sponsor details

Research and Development Central Office
Tennent Institute
38 Church Street
G11 6NT
United Kingdom

Sponsor type




Funder type


Funder name

North Glasgow University Hospitals NHS Division (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

1. Presentation (published abstract) at an international meeting
2. Planned publication in BMC Research Notes

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

16/03/2016: Plain English summary and publication and dissemination plan have been added. The trial participating centres have also been updated to include St James Hospital, Dublin; Ninewells Hospital, Dundee; Western General Hospital, Edinburgh; Newcastle General Hospital. 04/03/2016: No publications found, verifying study status with principal investigator.