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

Phase 1

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

• Registration Number: EUCTR2006-003332-29-GB
• Lead Sponsor: ICORG, all-Ireland Cooperative Oncology Research Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-21
• Last Update Posted: 27 July 2020

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 10 to the power of 9 /L
• Platelet count > 100 x 10 to the power of 9 /L
• 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
• Patients known to have second or third degree heart block.
• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified