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Clinical Trial Summary

The aim of this prospective single-centre phase II study is to investigate the therapeutic efficacy and safety of cetuximab in combination with Gemcitabine and Oxaliplatin (GEMOX) in the palliative first line treatment of biliary tract cancer (BTC) patients.


Clinical Trial Description

Primary Objective(s) The primary objective of the study is to evaluate the best overall response of cetuximab in combination with gemcitabine and oxaliplatin (GEMOX) as first line treatment in patients with advanced or metastatic biliary tract cancer.

Secondary Objectives

The secondary objectives of this study are as follows:

- toxicity

- secondary resection rate

- progression-free survival (PFS)

- overall survival (OS) ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01216345
Study type Interventional
Source Association of Research on the Biology of Liver Tumors
Contact
Status Completed
Phase Phase 2
Start date October 2006
Completion date October 2009

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