A Randomised Phase II trial of Epirubicin, Oxaliplatin and Capecitebine (EOX) versus Docetaxel and Oxaliplatin (EITax) in the treatment of Advanced Gastro-oesophageal cancer - The ELECT trial - ELECT trial

Conditions: MedDRA version: 9.1Level: LLTClassification code 10062878Term: Gastrooesophageal cancer
Advanced Gastro-oesophageal cancer

Registration Number: EUCTR2006-003332-29-IE

Lead Sponsor: ICORG, all-Ireland Cooperative Oncology Research Group

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 140

Inclusion Criteria

•Unresectable or metastatic, histologically confirmed adenocarcinoma of the stomach, gastro-oesophageal junction or lower third of the oesophagus with measurable disease on CT scanning.
•No previous treatment for advanced disease (previous adjuvant/neo-adjuvant treatment acceptable if >12 months previously.)
•Absence of serious concomitant illness (i.e. MI within previous 6 months), uncontrolled angina, uncontrolled hypertension, severe COPD (>3 admissions for infective exacerbation in past 12 months) etc.
•ECOG performance status = 2.
•Age = to 18.
•Life expectancy = 3 months
•Adequate renal, hepatic and bone marrow function
•Creatinine Clearance = 50 ml/min as calculated using the Cockcroft and Gault formula.
•Liver function tests.
•Bilirubin = 1.0 x ULN
•AST = 1.5 x ULN
•ALT = 1.5 x ULN
•Haemoglobin > 10.0 g/dl
•Absolute neutrophil count >1.5 x x10 to the power of 9
•Platelet count > 100,000 x10 to the power of 9
•Before randomisation, written informed consent must be given according to ICH/GCP, and national/local regulations.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Symptoms or signs of peripheral neuropathy
•Previous or concurrent malignancy, with the exception of basal cell carcinoma of the skin or in-situ neoplasia of the uterine cervix.
•Known hypersensitivity to taxanes, oxaliplatin, or fluoropyrimidines.
•Pregnant or nursing.
• Female of child-bearing potential not taking adequate contraceptive precautions.
•Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial