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 |
| ClinicalTrials.gov (NCT) | NCT00262769 |
| Clinical Trials Information System (CTIS) | 2004-004882-14 |
| Protocol serial number | N/A |
| Sponsor | University College London (UK) |
| Funder | Clinical Trials Advisory and Awards Committee (CTAAC) Ref: C1813/A4853 |
- 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
Contact information
Dr John Bridgewater
Scientific
Scientific
Royal Free & University College Medical School
Courtauld Building
91 Riding House Street
London
W1W 7BS
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Gemcitabine, cisplatin |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 31/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Royal Free & University College Medical School
London
W1W 7BS
United Kingdom
W1W 7BS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/04/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes |
Editorial Notes
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
