Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT00737867
Status:
COMPLETED
Last Update Posted:
2011-04-04
First Post:
2008-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vinorelbine/Gemcitabine Versus Vinorelbine/Carboplatin in Advanced Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'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': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 444}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-01', 'studyFirstSubmitDate': '2008-08-19', 'studyFirstSubmitQcDate': '2008-08-19', 'lastUpdatePostDateStruct': {'date': '2011-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Health related quality of life (HrQoL)', 'timeFrame': '3 months'}, {'measure': 'Toxicity', 'timeFrame': '3 months'}, {'measure': 'Need for palliative radiotherapy', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lung cancer', 'chemotherapy', 'vinorelbine', 'gemcitabine', 'carboplatin', 'advanced lung cancer', 'non-small cell lung cancer'], 'conditions': ['Advanced Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore if the combination of vinorelbine and gemcitabine is better than vinorelbine and carboplatin in the treatment of advanced non-small cell lung cancer, in terms of survival, quality of life and need for palliative radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-small cell lung cancer stage IIIB or IV\n* Not eligible for radical radiotherapy or surgery\n* WHO performance status 0-2\n\nExclusion Criteria:\n\n* Pregnancy\n* Other clinical active cancer disease\n* ALAT/ALP more than 3 times upper normal limit, bilirubin \\>1.5 upper limit\n* Bowel disease that causes malabsorption'}, 'identificationModule': {'nctId': 'NCT00737867', 'briefTitle': 'Vinorelbine/Gemcitabine Versus Vinorelbine/Carboplatin in Advanced Non-small Cell Lung Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'The Norwegian Lung Cancer Study Group'}, 'officialTitle': 'Vinorelbine Plus Gemcitabine (VG) Versus Vinorelbine Plus Carboplatin (VC) in Advanced Non-small Cell Lung Cancer. An Open Randomized Multicenter Phase III Trial From Norwegian Lung Cancer Study Group (NLCG)', 'orgStudyIdInfo': {'id': '11066741577'}, 'secondaryIdInfos': [{'id': 'Eudra-CT-nr 2006-002927-18'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Day 1: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Gemcitabine infusion 1000 mg/m2 Day 8: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Gemcitabine infusion 1000 mg/m2\n\nAll patients will receive a maximum of 3 courses with an interval of 3 weeks', 'interventionNames': ['Drug: Vinorelbine', 'Drug: Gemcitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': "Day 1: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Carboplatin infusion AUC = 5 (Calvert's formula) Day 8: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2\n\nAll patients will receive a maximum of 3 courses with an interval of 3 weeks", 'interventionNames': ['Drug: Vinorelbine', 'Drug: Carboplatin']}], 'interventions': [{'name': 'Vinorelbine', 'type': 'DRUG', 'otherNames': ['Navelbine® Oral'], 'description': 'Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2', 'armGroupLabels': ['A']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemzar', 'Gemcitabin'], 'description': 'Day 1: Gemcitabine infusion 1000 mg/m2 Day 8: Gemcitabine infusion 1000 mg/m2', 'armGroupLabels': ['A']}, {'name': 'Vinorelbine', 'type': 'DRUG', 'otherNames': ['Navelbine® Oral'], 'description': 'Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2', 'armGroupLabels': ['B']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': "Day 1: Carboplatin infusion AUC = 5 (Calvert's formula)", 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Øystein Fløtten', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'zip': '7000', 'city': 'Haugesund', 'country': 'Norway', 'facility': 'Sverre Fluge', 'geoPoint': {'lat': 59.41378, 'lon': 5.268}}, {'city': 'Kristiansand', 'country': 'Norway', 'facility': 'Heidi Rolke', 'geoPoint': {'lat': 58.14671, 'lon': 7.9956}}, {'zip': '7000', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Tore Amundsen', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Øystein Fløtten', 'role': 'STUDY_CHAIR', 'affiliation': 'Haukeland University Hospital, thoracic department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Norwegian Lung Cancer Study Group', 'class': 'NETWORK'}, 'responsibleParty': {'oldNameTitle': 'Øystein Fløtten', 'oldOrganization': 'Haukeland University Hospital'}}}}