Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT00430651
Status:
COMPLETED
Last Update Posted:
2009-01-28
First Post:
2007-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Docetaxel and Carboplatin Versus Docetaxel as Second Line Treatment in Patients With Non-Small-Cell Lung Carcinoma (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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'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'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-27', 'studyFirstSubmitDate': '2007-02-01', 'studyFirstSubmitQcDate': '2007-02-01', 'lastUpdatePostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the overall survival between the two treatment groups', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Comparison of the objective response rates between the two treatment groups', 'timeFrame': 'Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)'}, {'measure': 'Evaluation and comparison of the toxicity between the two treatment groups', 'timeFrame': 'Toxicity assessment on each chemotherapy cycle'}, {'measure': 'Measurement and comparison of the health-related quality of life of patients on both treatment groups', 'timeFrame': 'Assessment every two cycles'}]}, 'conditionsModule': {'keywords': ['Non Small Cell Lung Cancer', '2nd line chemotherapy', 'Docetaxel'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This trial will compare the effectiveness of Docetaxel with or without Carboplatin as second line chemotherapy in patients with Non-Small Cell Lung Cancer, who have not been treated previously with Docetaxel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed NSCLC.\n* ECOG Performance Status 0-2.\n* No previous treatment with Docetaxel.\n* Measurable Disease.\n* Brain metastases that have been treated with radiotherapy should be stable and asymptomatic.\n* Adequate liver kidney and bone marrow function.\n* Patients must be able to understand the nature of this study and give written informed consent.\n\nExclusion Criteria:\n\n* Active cardiac disease: unstable angina or onset of angina within last 3 months, myocardial infarction within 6 months, congestive heart failure \\> class II, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.\n* Women who are pregnant or lactating.\n* Unknown HIV, chronic hepatitis B or chronic hepatitis C infections.\n* Serious neurologic or psychiatric disease.\n* Second primary malignancy within the past 5 years, except nonmelanomas skin cancer or in situ carcinoma of the cervix.\n* Active uncontrolled infection.'}, 'identificationModule': {'nctId': 'NCT00430651', 'briefTitle': 'Docetaxel and Carboplatin Versus Docetaxel as Second Line Treatment in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)', 'organization': {'class': 'OTHER', 'fullName': 'Hellenic Oncology Research Group'}, 'officialTitle': 'Multicenter Randomized Phase III Study Comparing Docetaxel With Carboplatin Versus Docetaxel Single Agent as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (NSCLC).', 'orgStudyIdInfo': {'id': 'CT/04.14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Docetaxel + Carboplatin', 'interventionNames': ['Drug: Docetaxel', 'Drug: Carboplatin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Docetaxel', 'interventionNames': ['Drug: Docetaxel']}], 'interventions': [{'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere'], 'description': 'Docetaxel 50 mg/m2 IV on days 1 and 15 every 28 days for 6 cycles', 'armGroupLabels': ['1', '2']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Docetaxel 50 mg/m2 IV over 1 hour followed by Carboplatin 4 AUC IV over 1 hour on days 1 and 15', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71110', 'city': 'Heraklion', 'state': 'Crete', 'country': 'Greece', 'facility': 'University Hospital of Crete', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}, {'city': 'Alexandroupoli', 'country': 'Greece', 'facility': 'University General Hospital of Alexandroupolis, Dep of Medical Oncology', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}, {'city': 'Athens', 'country': 'Greece', 'facility': '"IASO" General Hospital of Athnes, Dep of Medical Oncology', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': '"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': '"Sotiria" General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': '401 Military Hospital, Medical Oncology Unit', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Air Forces Military Hospital, Dep of Medical Oncology', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Piraeus', 'country': 'Greece', 'facility': '"Metaxa\'s" Anticancer Hospital of Pireaus', 'geoPoint': {'lat': 37.94203, 'lon': 23.64619}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': '"Theagenion" Anticancer Hospital of Thessaloniki', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Vassilis Georgoulias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Crete, Dep of Medical Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hellenic Oncology Research Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital of Crete', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'V.Georgoulias', 'oldOrganization': 'Hellenic Oncology Research Group'}}}}