Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT00198393
Status:
COMPLETED
Last Update Posted:
2010-04-30
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV
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': 'D000077156', 'term': 'Gefitinib'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'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': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-28', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2010-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage IIIB/IV NSCLC', 'patients with performance status 2 or 3.'], 'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'referencesModule': {'references': [{'pmid': '18235404', 'type': 'BACKGROUND', 'citation': 'Moro-Sibilot D, Pluquet E, Zalcman G, Brechot JM, Souquet PJ, Debieuvre D, Morin F, Morere JF. [What treatment for a patient of PS 2-3 with stage IV non-small cell lung cancer?]. Rev Mal Respir. 2007 Oct;24(8 Pt 2):6S120-4. French.'}, {'pmid': '20400201', 'type': 'RESULT', 'citation': 'Morere JF, Brechot JM, Westeel V, Gounant V, Lebeau B, Vaylet F, Barlesi F, Urban T, Souquet PJ, Debieuvre D, Baudrin L, Zalcman G, Morin F, Milleron B, Moro-Sibilot D. Randomized phase II trial of gefitinib or gemcitabine or docetaxel chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2 or 3 (IFCT-0301 study). Lung Cancer. 2010 Dec;70(3):301-7. doi: 10.1016/j.lungcan.2010.03.003. Epub 2010 Apr 18.'}], 'seeAlsoLinks': [{'url': 'http://www.ifct.fr', 'label': 'Official website'}]}, 'descriptionModule': {'briefSummary': 'Patients presenting a deterioration of the general state (performance status \\[PS\\] 2-3), constitute a population which needs an adapted treatment. An analysis was made of the evolution of PS 2 patients included in the Eastern Cooperative Oncology Group (ECOG) 1594 trial which evaluated associations of new cytotoxic agents (gemcitabine, paclitaxel, docetaxel) with cisplatin. During this trial, the inclusion of these patients stopped due to the occurrence of toxicities more frequent than in the other populations (PS 0-1). At the end of this study, with the analysis of total toxicity, this one was not higher than that noted in the groups of PS 0 and 1 patients. In the population of PS 2 patients, 5 deaths had been noted, but the analysis showed that only 2 were due to the treatment. It was noted that the lower survival compared to the others was related to the disease and not to the treatment. These patients are often symptomatic and need palliative treatment. The benefit of chemotherapy should not be denied. They should profit from a monochemotherapy with the new cytotoxic agents, without associated platinum salt.', 'detailedDescription': 'Arm A Iressa 250 mg daily PROG/TOX --\\> Taxotere 75 mg/m² d1 (d1=d22)\n\nArm B Gemzar 1250 mg/m² d1 \\& d8 (d1=d22) PROG/TOX --\\> Iressa 250 mg daily\n\nArm C Taxotere 75 mg/m² d1 (d1=d22) PROG/TOX --\\> Iressa 250 mg daily'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage IIIB/IV NSCLC\n* patients with performance status 2 or 3.'}, 'identificationModule': {'nctId': 'NCT00198393', 'briefTitle': 'Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV', 'organization': {'class': 'OTHER', 'fullName': 'Intergroupe Francophone de Cancerologie Thoracique'}, 'officialTitle': 'Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV', 'orgStudyIdInfo': {'id': 'IFCT-0301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Gefitinib', 'interventionNames': ['Drug: Gefitinib']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Gemcitabine', 'interventionNames': ['Drug: gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'Docetaxel', 'interventionNames': ['Drug: Docetaxel']}], 'interventions': [{'name': 'Gefitinib', 'type': 'DRUG', 'description': '250 mg/day, until progression', 'armGroupLabels': ['A']}, {'name': 'gemcitabine', 'type': 'DRUG', 'description': '1250 mg/m² D1 and D8 (D1=D28, until progression)', 'armGroupLabels': ['B']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': '75 mg/m² D1 (D1=D22, until progression)', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93000', 'city': 'Bobigny', 'country': 'France', 'facility': 'CHU Avicenne - Oncologie', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Grenoble - pneumologie', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Jean-Francois Morere, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intergroupe Francophone de Cancerologie Thoracique'}, {'name': 'Denis Moro-Sibilot, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intergroupe Francophone de Cancerologie Thoracique'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intergroupe Francophone de Cancerologie Thoracique', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}, {'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Pr Jean-François Morère', 'oldOrganization': 'Intergroupe Francophone de Cancérologie Thoracique'}}}}