Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-25 @ 3:02 PM
Study NCT ID:
NCT01710592
Status:
COMPLETED
Last Update Posted:
2013-01-10
First Post:
2012-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'lastUpdateSubmitDate': '2013-01-08', 'studyFirstSubmitDate': '2012-10-15', 'studyFirstSubmitQcDate': '2012-10-17', 'lastUpdatePostDateStruct': {'date': '2013-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'Two Years'}], 'secondaryOutcomes': [{'measure': 'In addition we will examine the effect of treatment on time to progression.', 'timeFrame': 'Two Years'}, {'measure': 'To examine the associated toxicity from treatment', 'timeFrame': '2 years'}, {'measure': 'To examine the effect of treatment on survival', 'timeFrame': '2 years'}, {'measure': 'To examine the effect of treatment on Quality of life.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastro Oesophageal Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPrimary Objective:\n\nDetermine 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.\n\nSecondary Objective:\n\nTo examine the effect of treatment on time to progression, progression free survival, overall survival, quality of life, and the associated toxicity from treatment.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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).\n* No previous treatment for advanced disease (previous adjuvant/neo-adjuvant treatment acceptable if \\>12 months previously).\n* 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.\n* ECOG performance status ≤ 2.\n* Age ≥ to 18.\n* Life expectancy ≥ 3 months\n* Adequate renal, hepatic and bone marrow function\n* Creatinine clearance ≥ 50 ml/min as calculated using the Cockcroft and Gault formula (see Appendix L).\n* Liver function tests:\n\nBilirubin ≤ 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.\n\n•Before randomisation, written informed consent must be given according to ICH/GCP, and national/local regulations.\n\nExclusion Criteria:\n\n* Symptoms or signs of peripheral neuropathy.\n* Patients known to have second or third degree heart block.\n* Previous or concurrent malignancy, with the exception of basal cell carcinoma of the skin or in-situ neoplasia of the uterine cervix.\n* Known hypersensitivity to taxanes, oxaliplatin, or fluoropyrimidines.\n* Pregnant or nursing.\n* Female of child-bearing potential, or male partner of female of child bearing potential not taking adequate contraceptive precautions.\n* 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'}, 'identificationModule': {'nctId': 'NCT01710592', 'acronym': 'ELECT', 'briefTitle': 'A Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer', 'nctIdAliases': ['NCT00806949'], 'organization': {'class': 'NETWORK', 'fullName': 'Cancer Trials Ireland'}, 'officialTitle': 'A Randomised Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer', 'orgStudyIdInfo': {'id': 'ICORG 06-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Epirubicin, Oxaliplatin, Capecitabine', 'description': '* Epirubicin 50mg/m2 (day 1) bolus injection\n* Oxaliplatin 130mg/m2 (day 1) in 250mls of 5% dextrose. i.v. over 2 hours\n* Capecitabine 625mg/m2 (days 1-21) b.d. orally\n* 8 x 3-weekly cycle', 'interventionNames': ['Drug: Epirubicin', 'Drug: Oxaliplatin', 'Drug: Capecitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Docetaxel, Oxaliplatin', 'description': '* 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)\n* Oxaliplatin 85mg/m2 (days 1 \\& 15)in 250mls of 5% dextrose. i.v. over 2 hours\n* 6 x 4-weekly cycle', 'interventionNames': ['Drug: Oxaliplatin', 'Drug: Docetaxel']}], 'interventions': [{'name': 'Epirubicin', 'type': 'DRUG', 'armGroupLabels': ['Epirubicin, Oxaliplatin, Capecitabine']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'armGroupLabels': ['Docetaxel, Oxaliplatin', 'Epirubicin, Oxaliplatin, Capecitabine']}, {'name': 'Capecitabine', 'type': 'DRUG', 'armGroupLabels': ['Epirubicin, Oxaliplatin, Capecitabine']}, {'name': 'Docetaxel', 'type': 'DRUG', 'armGroupLabels': ['Docetaxel, Oxaliplatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cork', 'country': 'Ireland', 'facility': 'Mercy University Hospital', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Beaumont Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Mater Misericordiae University hospital & Mater Private Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': "St James's Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'The Adelaide and Meath Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Waterford', 'country': 'Ireland', 'facility': 'Waterford Regional Hospital', 'geoPoint': {'lat': 52.25833, 'lon': -7.11194}}], 'overallOfficials': [{'name': 'Martin Eatock, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Trials Ireland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Trials Ireland', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}