Advanced Gastro-oesophageal cancer MedDRA version: 9.1 Level: LLT Classification code 10062878 Term: Gastrooesophageal cancer
Conditions
Interventions
Trade Name: Taxotere
Product Name: Docetaxel
Pharmaceutical Form: Solution for infusion
Trade Name: Eloxatin
Product Name: Oxaliplatin
Pharmaceutical Form: Concentrate for solution for infusion
Trad
Sponsors
ICORG, all-Ireland Cooperative Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to 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: In addition we will examine the effect of treatment on time to progression, survival and quality of life and the associated toxicity from treatment. The original tumour sample tissue blocks will be collected where available if consent has been obtained for donation of the samples, for pharmacogenetic studies to determine genomic signatures potentially predictive of response to treatment and/or clinical benefit. The paraffin embedded tissue blocks will be requested to be sent after the first 70 patients have been randomised, and then again at after the randomisation of the last patient. The blocks would be sent to the custodian Prof. P. Johnston, Tissue Resource Centre, Centre for Cancer Research and Cell Biology, QUB, Belfast City Hospital, Lisburn Road, Belfast, BT9 7AB, Northern Ireland, where they would be stored. This is a dedicated centre operating to the the standards define by the UK Human Tissue Act of 2006. ;Primary end point(s): Primary End Point: • To determine the tumour response rate. Secondary End Points: • Determine and evaluate toxicities of these regimens. • Assess quality of life during treatment. • Determine time to progression and overall survival in both treatment arms. | — |
Countries
Ireland, United Kingdom
Outcome results
None listed