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

Phase 3

Completed

• Conditions: Cancer; Advanced or metastatic biliary tract carcinoma; Biliary tract carcinoma

• Registration Number: ISRCTN82956140
• Lead Sponsor: niversity College London (UK)

Brief Summary

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20375404

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-03-21
• Study Completion: 2009-03-31
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.