EUCTR2006-003332-29-GBActive, not recruitingPhase 1
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
ICORG, all-Ireland Cooperative Oncology Research Group0 sites140 target enrollmentStarted: August 21, 2008Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 140
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
Similar Trials
Active, not recruiting
Not Applicable
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 trialAdvanced Gastro-oesophageal cancerMedDRA version: 9.1Level: LLTClassification code 10062878Term: Gastrooesophageal cancerEUCTR2006-003332-29-IEICORG, all-Ireland Cooperative Oncology Research Group140
Recruiting
Not Applicable
Phase II randomized controlled trial of epirubicin hydrochloride and miriplatin hydrate as anticancer agents for transcatheter arterial chemoembolization of hepatocellular carcinomahepatocellular carcinomaJPRN-UMIN000011785Takasaki General Medical Center, National Hospital Organization60
Active, not recruiting
Phase 1
PALLIATIVE CHEMOTHERAPY (EOX) & FISH OIL INFUSION (OMEGAVEN) IN OESOPHAGO-GASTRIC CANCER PATIENTSnresectable oesophageal and/or gastric cancerEUCTR2011-003950-24-GBniversity Hospitals of Leicester NHS Trust21
Completed
Not Applicable
A randomized phase II trial comparing epirubicin, cisplatin, and capecitabine versus the combination of epirubicin, cisplatin, and capecitabine with pravastatin in patients with irresectable or metastatic gastric carcinomaCancerISRCTN23062732Erasmus Medical Center, Department of Medical Oncology (Netherlands)43
Completed
Phase 2
Phase II trial of Epirubicin / Cyclophosphamide (EC) followed by Nab-paclitaxel as neoadjuvant chemotherapy for node positive breast cancerBreast CancerJPRN-UMIN000009853Dokkyo Medical University23