Whilst oxaliplatin and docetaxel have established activity in the treatment of advanced gastro-oesophageal cancer, their role, however, in the management of this disease remains unclear. Furthermore it is unclear whether this disease is optimally treated with a combination of two or three cytotoxic drugs. This trial aims to determine whether the combination of oxaliplatin and weekly docetaxel warrants further investigation in a formal phase III trial. The combination of epirubicin, oxaliplatin and capecitabine will be the comparator arm for this evaluation. Primary Objective: Determine in a randomised study if the response rate to docetaxel and oxaliplatin (ElTax) is comparable to epirubicin, oxaliplatin and capecitabine (EOX) and warrants further evaluation in advanced gastro-oesophageal cancer. Secondary Objective: To examine the effect of treatment on time to progression, progression free survival, overall survival, quality of life, and the associated toxicity from treatment.
This is a randomised two-arm parallel group phase II study. 140 patients will be recruited over a period of 12 months, and will be randomised to receive either eight 3-weekly cycles of Epirubicin, Oxaliplatin and Capecitabine (EOX) or six 4-weekly cycles of Docetaxel and Oxaliplatin (EITax).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Mercy University Hospital
Cork, Ireland
Beaumont Hospital
Dublin, Ireland
Mater Misericordiae University hospital & Mater Private Hospital
Dublin, Ireland
St James's Hospital
Dublin, Ireland
The Adelaide and Meath Hospital
Dublin, Ireland
Waterford Regional Hospital
Waterford, Ireland
Determine in a randomised study if the response rate to docetaxel and oxaliplatin (ElTax) is comparable to epirubicin, oxaliplatin and capecitabine (EOX) and warrants further evaluation in advanced gastro-oesophageal cancer
Time frame: Two Years
In addition we will examine the effect of treatment on time to progression.
Time frame: Two Years
To examine the associated toxicity from treatment
Time frame: 2 years
To examine the effect of treatment on survival
Time frame: 2 years
To examine the effect of treatment on Quality of life.
Time frame: 2 years
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