Gastro Oesophageal Cancer Clinical Trial
Official title:
A Randomised Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer
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). ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment