Know Cancer

forgot password

A Randomised Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer

Phase 2
18 Years
Not Enrolling
Gastro Oesophageal Cancer

Thank you

Trial Information

A Randomised Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer

This is a randomised two-arm parallel group phase II study. 140 patients will be recruited
over a period of 12 months, and will be randomised to receive either eight 3-weekly cycles
of Epirubicin, Oxaliplatin and Capecitabine (EOX) or six 4-weekly cycles of Docetaxel and
Oxaliplatin (EITax).

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Two Years

Safety Issue:


Principal Investigator

Martin Eatock, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

ICORG- All Ireland Cooperative Oncology Research Group


Ireland: Irish Medicines Board

Study ID:

ICORG 06-05



Start Date:

May 2007

Completion Date:

Related Keywords:

  • Gastro Oesophageal Cancer
  • Esophageal Diseases
  • Esophageal Neoplasms