Gastro Oesophageal Cancer Clinical Trial
— ELECTOfficial title:
A Randomised Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer
| NCT number | NCT01710592 |
| Other study ID # | ICORG 06-05 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | October 15, 2012 |
| Last updated | January 8, 2013 |
| Start date | May 2007 |
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.
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 (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. 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, 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Ireland | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| ICORG- All Ireland Cooperative Oncology Research Group |
Ireland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | In addition we will examine the effect of treatment on time to progression. | Two Years | Yes | |
| Secondary | To examine the associated toxicity from treatment | 2 years | Yes | |
| Secondary | To examine the effect of treatment on survival | 2 years | No | |
| Secondary | To examine the effect of treatment on Quality of life. | 2 years | No |