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.
OBJECTIVES:
Primary
- 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.
Secondary
- Compare the time to progression, survival, and quality of life of patients treated with
these regimens.
- 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
unacceptable toxicity.
- 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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Tumor response rate (partial and complete response) as assessed by CT scan
No
Martin Eatock, MD
Principal Investigator
Belfast City Hospital Trust Incorporating Belvoir Park Hospital
Unspecified
CDR0000629056
NCT00806949
May 2007
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