Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT00198367
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) Non-Small Cell Lung Cancer (NSCLC)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-23', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities)', 'timeFrame': 'at week 22'}]}, 'conditionsModule': {'keywords': ['operable and resectable stage IIIA (T1-3, N2) NSCLC'], 'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '19879013', 'type': 'RESULT', 'citation': 'Girard N, Mornex F, Douillard JY, Bossard N, Quoix E, Beckendorf V, Grunenwald D, Amour E, Milleron B. Is neoadjuvant chemoradiotherapy a feasible strategy for stage IIIA-N2 non-small cell lung cancer? Mature results of the randomized IFCT-0101 phase II trial. Lung Cancer. 2010 Jul;69(1):86-93. doi: 10.1016/j.lungcan.2009.10.003. Epub 2009 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'Stage IIIA non-small cell lung cancers comprising a mediastinal ganglionic invasion N2 account for 20 to 30% of the NSCLCs. They are almost always potentially resectable, but the results obtained by surgery alone or surgery followed by chemotherapy (CT) and/or radiotherapy (RT) are insufficient. The neoadjuvant approach was tested, in randomized tests of exclusive CT, or in noncomparative tests of RT-CT.', 'detailedDescription': 'These results justify the choice of the study design currently suggested, testing the preoperative feasibility\n\n1. chemotherapy: cisplatin-Gemzar (arm A) or\n2. chemoradiotherapy: cisplatin-navelbine-radiotherapy (arm B) or Carboplatin-Taxol-radiotherapy (arm C).\n\nThe results obtained, in terms of feasibility and toxicity, will make it possible to select the optimal diagrams for a phase III study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Operable and resectable stage IIIA (T1-3, N2) NSCLC\n* World Health Organization (WHO) performance status of 1 or less\n\nExclusion Criteria:\n\n* Severe cardiac, respiratory, renal or hepatic failure'}, 'identificationModule': {'nctId': 'NCT00198367', 'briefTitle': 'Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) NSCLC. Randomized Phase II Study', 'orgStudyIdInfo': {'id': 'IFCT-0101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cisplatin-Gemzar', 'description': 'Cisplatin-Gemzar', 'interventionNames': ['Drug: Cisplatin-Gemzar']}, {'type': 'EXPERIMENTAL', 'label': 'Cisplatin-Navelbine-Radiotherapy', 'description': 'Cisplatin-Navelbine-Radiotherapy', 'interventionNames': ['Drug: Cisplatin-Navelbine-Radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Carboplatin-Taxol-Radiotherapy', 'description': 'Carboplatin-Taxol-Radiotherapy', 'interventionNames': ['Drug: Carboplatin-Taxol-Radiotherapy']}], 'interventions': [{'name': 'Cisplatin-Gemzar', 'type': 'DRUG', 'armGroupLabels': ['Cisplatin-Gemzar']}, {'name': 'Cisplatin-Navelbine-Radiotherapy', 'type': 'DRUG', 'armGroupLabels': ['Cisplatin-Navelbine-Radiotherapy']}, {'name': 'Carboplatin-Taxol-Radiotherapy', 'type': 'DRUG', 'armGroupLabels': ['Carboplatin-Taxol-Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon-Sud - Radiotherapie/Oncologie', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'overallOfficials': [{'name': 'Francoise Mornex, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}, {'name': 'Bernard Milleron, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intergroupe Francophone de Cancerologie Thoracique'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}