Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-25 @ 2:19 PM
Study NCT ID:
NCT00290966
Status:
COMPLETED
Last Update Posted:
2009-04-29
First Post:
2006-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Multicenter Study Comparing Docetaxel Plus Cisplatin and 5-FU to Cisplatin Plus 5-FU in Advanced Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 610}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2003-05'}, 'lastUpdateSubmitDate': '2009-04-28', 'studyFirstSubmitDate': '2006-02-09', 'studyFirstSubmitQcDate': '2006-02-10', 'lastUpdatePostDateStruct': {'date': '2009-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to detect a significant increase in time to progression in favor of docetaxel plus cisplatin and 5-FU compared to cisplatin plus 5-FU. Tumor assessments (assessed with WHO criteria) had to be performed every 8 weeks until progression'}], 'secondaryOutcomes': [{'measure': 'Patients were to be followed until death (overall survival). Clinical and laboratory were assessed with NCIC-CTG scale, before each cycle. Quality of life and clinical benefit were assessed every 2 weeks until progression and then every 3 months.'}]}, 'conditionsModule': {'keywords': ['docetaxel', 'stomach neoplasm'], 'conditions': ['Stomach Neoplasm']}, 'referencesModule': {'references': [{'pmid': '17075117', 'type': 'RESULT', 'citation': 'Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, Rodrigues A, Fodor M, Chao Y, Voznyi E, Risse ML, Ajani JA; V325 Study Group. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol. 2006 Nov 1;24(31):4991-7. doi: 10.1200/JCO.2006.06.8429.'}]}, 'descriptionModule': {'briefSummary': 'Phase II:\n\nPrimary objective: to select one of the 2 test arms (docetaxel with cisplatin, docetaxel with cisplatin and 5-FU), based primarily on complete responses, to advance to a phase III survival comparison against the CDDP + 5-FU control arm.\n\nSecondary objective: to evaluate the quantitative and qualitative safety profile of the 2 test groups.\n\nPhase III:\n\nPrimary objective: to detect a statistically significant increase in time to progression (TTP) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm (cisplatin plus 5-FU).\n\nMain secondary objective: to detect a statistically significant increase in overall survival (OS) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm (cisplatin plus 5-FU).\n\nOther secondary objectives: to compare response rates, time to treatment failure, duration of response, safety profiles, quality of life and disease-related symptoms.Socio-economic data will be collected in order to be able to perform an analysis by country when necessary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient's consent form obtained, signed and dated before beginning specific protocol procedures.\n* Gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction, histologically proven.\n* Measurable and/or evaluable metastatic disease; if a single metastatic lesion is the only manifestation of the disease, cytology or histology is mandatory. Locally recurrent disease is accepted provided that there is at least one measurable lesion (e.g. lymph node).\n* Performance status Karnofsky index \\> 70%.\n* Life expectancy of more than 3 months.\n* Adequate haematological and biochemistry parameters\n* No prior palliative chemotherapy, previous adjuvant (and/or neo-adjuvant) chemotherapy is allowed if more than 12 months has elapsed between the end of adjuvant (or neo-adjuvant) therapy and first relapse.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Patients (M/F) with reproductive potential not implementing adequate contraceptive measures.\n* Other tumor type than adenocarcinoma (leiomyosarcoma ; lymphoma).\n* Any prior palliative chemotherapy. Prior adjuvant (and/or neo-adjuvant) chemotherapy with a first relapse within 12 months from the end of adjuvant (or neo-adjuvant).\n* Prior treatment with taxanes. Prior CDDP as adjuvant (and/or neo-adjuvant) chemotherapy with cumulative dose \\> 300 mg/m²."}, 'identificationModule': {'nctId': 'NCT00290966', 'briefTitle': 'Randomized Multicenter Study Comparing Docetaxel Plus Cisplatin and 5-FU to Cisplatin Plus 5-FU in Advanced Gastric Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Open Label, Randomized Multicentre Phase II/III Study of Docetaxel in Combination With Cisplatin (CDDP) or Docetaxel in Combination With 5-Fluorouracil (5-FU) and CDDP Compared to the Combination of CDDP and 5-FU in Patients With Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease', 'orgStudyIdInfo': {'id': 'EFC6044'}, 'secondaryIdInfos': [{'id': 'XRP6976E-325'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'XRP6976', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jaffer Ajani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MD Anderson Cancer Center, Houston, Texas, US'}, {'name': 'E. Van Cutsem, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital Gasthuisberg, Leuven, Belgium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}}}}