Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-01 @ 6:12 PM
Study NCT ID:
NCT00320359
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2006-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topotecan Plus Cisplatin Versus Etoposide Plus Cisplatin In 1st Line Extensive Disease Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium'], 'submissionTracking': {'submissionInfos': [{'releaseDate': '2018-01-05', 'unreleaseDate': '2018-08-15'}], 'estimatedResultsFirstSubmitDate': '2018-01-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-27', 'studyFirstSubmitDate': '2006-05-01', 'studyFirstSubmitQcDate': '2006-05-01', 'lastUpdatePostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median overall survival time of participants', 'timeFrame': 'Up to 1 year after randomization of the last patient'}], 'secondaryOutcomes': [{'measure': 'Number of participants with one year survival rate of the participants', 'timeFrame': 'Up to 1 year after randomization of the last patient'}, {'measure': 'Median time of disease progression', 'timeFrame': 'up to 1 year after randomization of the last patient'}, {'measure': 'Median time to event (progressive disease or death) of participants', 'timeFrame': 'Up to 1 year after randomization of the last patient'}, {'measure': 'Median time to response to chemotherapy', 'timeFrame': 'Up to 1 year after randomization of the last patient'}, {'measure': 'Median response duration', 'timeFrame': 'Up to 1 year after randomization of the last patient'}, {'measure': 'Number of participants with objective response', 'timeFrame': 'Up to 1 year after randomization of the last patient'}, {'measure': 'Mean lung cancer symptom score (LCSS)', 'timeFrame': 'Up to 18 weeks'}, {'measure': 'Mean eastern cooperative oncology group (ECOG) score', 'timeFrame': 'Up to 18 weeks'}, {'measure': 'Number of participants with adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': 'Up to 1 year after randomization of the last patient'}, {'measure': 'Mean change from Baseline in hemoglobin value', 'timeFrame': 'Baseline and up to 18 weeks'}, {'measure': 'Mean change from Baseline in leukocytes, neutrophils and platelets count', 'timeFrame': 'Baseline and up to 18 weeks'}, {'measure': 'Mean change from Baseline in red blood cells (RBCs)', 'timeFrame': 'Baseline and up to 18 weeks'}, {'measure': 'Mean change from Baseline in Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase and Lactate dehydrogenase (LDH)', 'timeFrame': 'Baseline and up to 18 weeks'}, {'measure': 'Mean change from Baseline in Blood urea nitrogen (BUN), Potassium, Sodium and urea', 'timeFrame': 'Baseline and up to 18 weeks'}, {'measure': 'Mean change from Baseline in Creatinine and Total bilirubin', 'timeFrame': 'Baseline and up to 18 weeks'}, {'measure': 'Mean change from Baseline in Creatinine clearance'}, {'measure': 'Mean change from Baseline in total protein', 'timeFrame': 'Baseline and up to 18 weeks'}, {'measure': 'Number of participants with abnormal urinalysis results'}, {'measure': 'Mean change from Baseline in weight', 'timeFrame': 'Baseline and up to 18 weeks'}, {'measure': 'Mean change from Baseline in Body surface area', 'timeFrame': 'Baseline and up to 18 weeks'}]}, 'conditionsModule': {'keywords': ['First-line Cisplatin', 'Small Cell Lung Cancer', 'topotecan', 'etoposide', 'Extensive Disease'], 'conditions': ['Lung Cancer, Small Cell']}, 'descriptionModule': {'briefSummary': 'Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st line Small Cell Lung Cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Evaluable extensive small cell lung cancer, extensive disease.\n* Eastern Cooperative Oncology Group (ECOG) performance status \\< 2.\n* Life expectancy \\> 3 months.\n* Fit to receive any of the treatments.\n* No prior chemotherapy.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Extensive disease treatable with radiotherapy.\n* Past or current history of other malignant disease.\n* Prior chemotherapy.\n* Pregnancy, lactating or lack of effective contraception.\n* Concurrent severe medical problems other than small cell lung cancer.\n* Patients with central nervous system metastases receiving more than 12 mg /day dexamethasone or equivalent to control symptoms.'}, 'identificationModule': {'nctId': 'NCT00320359', 'briefTitle': 'Topotecan Plus Cisplatin Versus Etoposide Plus Cisplatin In 1st Line Extensive Disease Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open-Label, Multicentre, Randomised, Phase III Study Comparing Topotecan/Cisplatin and Topotecan/Etoposide Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '104864-A/479'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A', 'description': 'Cisplatin 75 mg/m2 i.v., day 1, Etoposide 100 mg/m2 i.v., days 1-3', 'interventionNames': ['Drug: Intravenous etoposide/cisplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'Topotecan 1 mg/ m2, i.v., days 1-5 Cisplatin 75 mg/m2 i.v., days 5', 'interventionNames': ['Drug: Intravenous topotecan/cisplatin']}], 'interventions': [{'name': 'Intravenous topotecan/cisplatin', 'type': 'DRUG', 'description': 'Topotecan 1 mg/m2 should be administered intravenously over a period of 30 minutes on days 1-5. Then a 30 minute saline flush should be administered followed by the cisplatin on day 5.\n\nCisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 5 after topotecan.', 'armGroupLabels': ['Arm B']}, {'name': 'Intravenous etoposide/cisplatin', 'type': 'DRUG', 'description': 'Cisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 1. Cisplatin should be given simultaneously to post-hydration to ensure a high volume fluid.\n\nEtoposide 100 mg/m2 should be administered after cisplatin intravenously over a period not less than 30 minutes on days 1 -3.', 'armGroupLabels': ['Arm A']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-6719', 'city': 'Bludesch', 'country': 'Austria', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.2, 'lon': 9.73306}}, {'zip': 'A-9020', 'city': 'Klagenfurt', 'country': 'Austria', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.62472, 'lon': 14.30528}}, {'zip': 'A-4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': 'A-1140', 'city': 'Vienna', 'country': 'Austria', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK 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