Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-01-03 @ 10:22 PM
Study NCT ID:
NCT00148395
Status:
COMPLETED
Last Update Posted:
2008-04-22
First Post:
2005-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D016685', 'term': 'Mitomycin'}, {'id': 'D007069', 'term': 'Ifosfamide'}], 'ancestors': [{'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': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'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': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D008937', 'term': 'Mitomycins'}, {'id': 'D045563', 'term': 'Indolequinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-21', 'studyFirstSubmitDate': '2005-09-07', 'studyFirstSubmitQcDate': '2005-09-07', 'lastUpdatePostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival'}], 'secondaryOutcomes': [{'measure': 'Event-free survival'}, {'measure': 'Quality of live'}]}, 'conditionsModule': {'conditions': ['Non-Small-Cell Lung Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study wants to assess different intensive therapy sequences for the treatment of non-small-cell lung cancer.\n\nIt claims less on the efficacy of different chemotherapy combinations, than more on the comparison of different strategies of sequential single-agent, sequential double-agent or sequential triple-agent therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histological verified non-small cell lung cancer. Cytological diagnosis is accepted for doubtless results.\n2. Present stage IIIb with malignant pleural effusion or stage IV disease. Tumor dissemination should not be irradiable in one field\n3. Age between 18 and 75 years\n4. Karnofsky index 70 - 100%\n5. Measurable or evaluable tumor parameter\n6. No prior chemotherapy for NSCLC\n7. Sufficient hematological parameter before start of therapy (leucocytes \\> 3.500/µl and platelets \\> 100.000/µl).\n8. Sufficient liver function (bilirubin \\< 1,6mg/dl)\n9. Sufficient renal function (creatinine \\< 1,5mg/dl and clearance \\> 60ml/min)\n10. Minimal estimated life expectancy \\> 3 months\n11. Written informed consent for study attendance\n12. Patient accessibility for therapy and follow up\n13. No attendance to an other study\n\nExclusion Criteria:\n\n1. Small-cell lung cancer oder tumors with small-cell fractions\n2. Local advanced irradiable stage III\n3. Previous chemotherapy because of other diseases, not longer than 3 years ago\n4. Simultaneous radiation of all present tumor manifestations\n5. Simultaneous or not longer than 3 years ago secondary malignancy, except carcinoma in situ of the cervix or dermal cancer, others than melanoma\n6. Respiratory insufficiency\n7. Heart insufficiency NYHA III and IV\n8. Peripheral arteriosclerosis stage III and IV\n9. Neurological and psychiatric diseases, which affect understanding of the study concept and the possibility to keep conditions of the protocol\n10. Pregnancy, breastfeeding or not ensured contraception\n11. HIV-infection\n12. Active hepatitis B and C\n13. Manifest infectious diseases before start of therapy\n14. Minimal estimated life expectancy \\< 3 months\n15. No written informed consent of the patient for study attendance and storage and disclosure of disease data according to the protocol'}, 'identificationModule': {'nctId': 'NCT00148395', 'briefTitle': 'Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy.', 'organization': {'class': 'OTHER', 'fullName': 'Aktion Bronchialkarzinom e.V.'}, 'officialTitle': 'Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy.', 'orgStudyIdInfo': {'id': 'NSCLC 06/2001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gemcitabine', 'type': 'DRUG'}, {'name': 'Navelbine', 'type': 'DRUG'}, {'name': 'Carboplatin', 'type': 'DRUG'}, {'name': 'Cisplatin', 'type': 'DRUG'}, {'name': 'Mitomycin', 'type': 'DRUG'}, {'name': 'Ifosfamide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34125', 'city': 'Kassel', 'country': 'Germany', 'facility': 'Klinikum Kassel GmbH', 'geoPoint': {'lat': 51.31667, 'lon': 9.5}}], 'overallOfficials': [{'name': 'Martin Wolf, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Klinikum Kassel GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aktion Bronchialkarzinom e.V.', 'class': 'OTHER'}}}}