A Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer
ELECT
A Randomised Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer
1 other identifier
interventional
35
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 15, 2012
CompletedFirst Posted
Study publicly available on registry
October 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedJanuary 10, 2013
January 1, 2013
5.6 years
October 15, 2012
January 8, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Two Years
Secondary Outcomes (4)
In addition we will examine the effect of treatment on time to progression.
Two Years
To examine the associated toxicity from treatment
2 years
To examine the effect of treatment on survival
2 years
To examine the effect of treatment on Quality of life.
2 years
Study Arms (2)
Epirubicin, Oxaliplatin, Capecitabine
ACTIVE COMPARATOR* Epirubicin 50mg/m2 (day 1) bolus injection * Oxaliplatin 130mg/m2 (day 1) in 250mls of 5% dextrose. i.v. over 2 hours * Capecitabine 625mg/m2 (days 1-21) b.d. orally * 8 x 3-weekly cycle
Docetaxel, Oxaliplatin
ACTIVE COMPARATOR* Docetaxel 20mg/m2 (days 1, 8 \& 15)in 250mls of 5% dextrose. i.v. over 30mins (Dexamethasone 8mg i.v, Chlorpheniramine 10mg i.v,Ranitidine 50mg i.v. to be given 30 minutes prior to Docetaxel) * Oxaliplatin 85mg/m2 (days 1 \& 15)in 250mls of 5% dextrose. i.v. over 2 hours * 6 x 4-weekly cycle
Interventions
Eligibility Criteria
You may qualify if:
- Unresectable or metastatic, histologically confirmed adenocarcinoma of the stomach, gastro-oesophageal junction or lower third of the oesophagus with measurable disease on CT scanning (see RECIST Criteria, Appendix C of the protocol for definition of measureable disease).
- 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 (see Appendix L).
- 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 109 /L, Platelet count \> 100 x109/L.
- Before randomisation, written informed consent must be given according to ICH/GCP, and national/local regulations.
You may not qualify if:
- 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, or male partner of 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Mercy University Hospital
Cork, Ireland
Beaumont Hospital
Dublin, Ireland
Mater Misericordiae University hospital & Mater Private Hospital
Dublin, Ireland
St James's Hospital
Dublin, Ireland
The Adelaide and Meath Hospital
Dublin, Ireland
Waterford Regional Hospital
Waterford, Ireland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Eatock, Dr
Cancer Trials Ireland
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2012
First Posted
October 19, 2012
Study Start
May 1, 2007
Primary Completion
December 1, 2012
Last Updated
January 10, 2013
Record last verified: 2013-01