Advanced or metastatic biliary tract carcinoma Cancer Biliary tract carcinoma
Conditions
Interventions
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/
Sponsors
University College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed