Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-01-05 @ 2:41 AM
Study NCT ID:
NCT00675194
Status:
COMPLETED
Last Update Posted:
2008-05-20
First Post:
2008-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Irinotecan and Capecitabine Versus(vs) Cisplatin and Capecitabine in Patients With Esophago-Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-16', 'studyFirstSubmitDate': '2008-05-06', 'studyFirstSubmitQcDate': '2008-05-07', 'lastUpdatePostDateStruct': {'date': '2008-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'response rate'}], 'secondaryOutcomes': [{'measure': 'safety'}, {'measure': 'progression free survival'}, {'measure': '1 year survival'}, {'measure': 'Quality of Life'}, {'measure': 'Analysis of the dose and efficacy of Epoetin beta weekly in anaemic patients'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cisplatin', 'capecitabine', 'gastric', 'irinotecan', 'metastatic', 'chemotherapy'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine which Arm (capecitabine + irinotecan versus capecitabine + cisplatin) shows higher response rates in the treatment of advanced gastric-oesophagal cancer\n\nFurthermore, comparison of progression-free survival, 1-year survival, Quality of Life and safety', 'detailedDescription': 'capecitabine + irinotecan versus capecitabine + cisplatin, as published by Kang et al. (ASCO 2006)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gastric or gastric-oesophagal junction adenocarcinoma\n* unidimensional measurable disease\n* Karnofsky index \\>/=60%\n\nExclusion Criteria:\n\n* prior chemo- or radiotherapy\n* colorectal diseases\n* brain metastases'}, 'identificationModule': {'nctId': 'NCT00675194', 'briefTitle': 'Efficacy of Irinotecan and Capecitabine Versus(vs) Cisplatin and Capecitabine in Patients With Esophago-Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'A Prospective, Open, Comparative Multicentre Phase II Study for the Evaluation of Irinotecan and Capecitabine Versus Cisplatin and Capecitabine in Advanced Gastric Adenocarcinoma or Gastric-Oesophagal Junction', 'orgStudyIdInfo': {'id': 'GC-ICE-2003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cisplatin, Irinotecan, Capecitabine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55101', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Johannes Gutenberg Universität , I. Medizinische Klinik und Polokilinik', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'overallOfficials': [{'name': 'Markus Moehler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johannes Gutenberg University Mainz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}}}}