Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-25 @ 2:30 PM
Study NCT ID:
NCT00812266
Status:
TERMINATED
Last Update Posted:
2016-01-26
First Post:
2008-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topotecan and Cisplatin Versus Etoposide and Carboplatin in 1st Line Treatment of Patients With Small Cell Lung Cancer and Extensive Disease (SCLC-ED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D019772', 'term': 'Topotecan'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'C098534', 'term': 'EC regimen'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 281}}, 'statusModule': {'whyStopped': 'Slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-23', 'studyFirstSubmitDate': '2008-12-19', 'studyFirstSubmitQcDate': '2008-12-19', 'lastUpdatePostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2 years survival', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Response rates', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SCLC', 'Extensive disease', 'topotecan'], 'conditions': ['Extensive Disease', 'First-Line', 'Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Randomised trial comparing standard chemotherapy with carboplatin and etoposide with a combination of topotecan and cisplatin in patients with inoperable lung cancer of small cell type.', 'detailedDescription': 'Fase III, multicenter randomised trial comparing up to six cycles of carboplatin and etoposide with up to six cycles of topotecan and cisplatin in patients with extensive stage small cell lung cancer and PS 0-3'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed SCLC\n* Extensive stage\n* No prior chemotherapy\n* WHO PS 0-3\n* Adequate organ function (liver, kidney)\n* Adequate hematology (bone marrow)\n* Informed consent\n\nExclusion Criteria:\n\n* PS 4\n* Inadequate organ function\n* Uncontrolled infection\n* Concomitant major medical contraindications'}, 'identificationModule': {'nctId': 'NCT00812266', 'briefTitle': 'Topotecan and Cisplatin Versus Etoposide and Carboplatin in 1st Line Treatment of Patients With Small Cell Lung Cancer and Extensive Disease (SCLC-ED)', 'organization': {'class': 'OTHER', 'fullName': 'Danish Oncological Lung Cancer Group'}, 'officialTitle': 'Randomized Phase III Trial of Topotecan and Cisplatin Versus Etoposide and Carboplatin in the Treatment of Patients With Previously Untreated Small Cell Lung Cancer and Extensive Disease', 'orgStudyIdInfo': {'id': 'DOLG7'}, 'secondaryIdInfos': [{'id': 'DOLG7', 'type': 'OTHER', 'domain': 'Danish Oncological Lung Cancer Group Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Topotecan + cisplatin', 'interventionNames': ['Drug: topotecan + cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Etoposide + carboplatin', 'interventionNames': ['Drug: Etoposide + carboplatin']}], 'interventions': [{'name': 'topotecan + cisplatin', 'type': 'DRUG', 'description': 'topotecan IV 2 mg/sqm d1-3 + cisplatin IV 50 mg/sqm d3 q3W', 'armGroupLabels': ['A']}, {'name': 'Etoposide + carboplatin', 'type': 'DRUG', 'description': 'Etoposide 120 mg/sqm IV d 1-3 + carboplatin AUC 5 d1 q3W', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Dept. Oncology, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Seppo W Langer, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Oncology, Rigshospitalet, Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Oncological Lung Cancer Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD pHD', 'investigatorFullName': 'Seppo W. Langer', 'investigatorAffiliation': 'Danish Oncological Lung Cancer Group'}}}}