A Randomised Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer - The ELECT Trial.
- Compare the response rate in patients with advanced esophageal, gastroesophageal
junction, or gastric cancer treated with epirubicin hydrochloride, oxaliplatin, and
capecitabine vs docetaxel and oxaliplatin.
- Compare the time to progression, survival, and quality of life of patients treated with
- Compare the toxicities associated with these regimens in these patients.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive epirubicin hydrochloride IV over 10-15 minutes and oxaliplatin
IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-21. Treatment
repeats every 3 weeks for up to 8 courses in the absence of disease progression or
- Arm II: Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and docetaxel IV
over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 6
courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality-of-life questionnaires periodically.
After completion of study treatment, patients are followed periodically.
Allocation: Randomized, Primary Purpose: Treatment
Tumor response rate (partial and complete response) as assessed by CT scan
Martin Eatock, MD
Belfast City Hospital Trust Incorporating Belvoir Park Hospital