Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-03-05 @ 7:53 PM
Study NCT ID:
NCT00259402
Status:
COMPLETED
Last Update Posted:
2009-12-07
First Post:
2005-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxaliplatin in Esophagus Cancer (Advanced) 1st Line
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-04', 'studyFirstSubmitDate': '2005-11-28', 'studyFirstSubmitQcDate': '2005-11-28', 'lastUpdatePostDateStruct': {'date': '2009-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy endpoints include tumor response, progression free and overall survival.', 'timeFrame': 'Throughout the whole study'}], 'secondaryOutcomes': [{'measure': 'Safety endpoints include summary of adverse events assessed by history, physical exams and laboratory evaluations.', 'timeFrame': 'Throughout the whole study duration'}]}, 'conditionsModule': {'conditions': ['Esophageal Neoplasms']}, 'descriptionModule': {'briefSummary': '* To determine the activity and efficacy of the schema specified as dose regimen\n* To determine the safety and tolerability of the oxaliplatin-cisplatin and 5FU'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ECOG 0-1\n* Patients with histologically proven epidermoid carcinoma or adenocarcinoma of esophagus or stomach, with unresectable or metastatic disease;\n* No previous treatment with chemotherapy or radiotherapy\n* Measurable lesion (uni or bidimensional)\n\nExclusion Criteria:\n\n* Creatinin clearance \\<50 mL/min\n* Total bilirubin \\>1.5\\*ULN (Upper Limit of Normal)\n* AST/ALT \\> 2.5\\*ULN\n* Total White Blood Cell \\<1.500.000/mL\n* Platelet count \\<100.000.000/mL\n* symptomatic sensitive peripheral neuropathy\n* pregnant or breast-feeding women\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00259402', 'briefTitle': 'Oxaliplatin in Esophagus Cancer (Advanced) 1st Line', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Phase II Open-label Single Arm Study of Oxaliplatin Combined With Cisplatin and 5FU in Advanced Esophagus Cancer Patients', 'orgStudyIdInfo': {'id': 'EFC_7127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxaliplatin', 'interventionNames': ['Drug: Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU)']}], 'interventions': [{'name': 'Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU)', 'type': 'DRUG', 'description': 'OXALIPLATIN 60 mg/m2/d, CISPLATIN 55 mg/m2/d, 5-FU 600 mg/m2/d with dose range and followed by radiotherapy', 'armGroupLabels': ['Oxaliplatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'José Mª Taboada', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Affairs Study Director', 'oldOrganization': 'sanofi-aventis'}}}}