Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-27 @ 9:21 PM
Study NCT ID:
NCT01038661
Status:
COMPLETED
Last Update Posted:
2014-02-28
First Post:
2009-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tax First-line Chemotherapy With Different Doses and Then Maintenance Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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': 'D002945', 'term': 'Cisplatin'}], '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': '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': 375}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-27', 'studyFirstSubmitDate': '2009-12-22', 'studyFirstSubmitQcDate': '2009-12-22', 'lastUpdatePostDateStruct': {'date': '2014-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS) during the maintenance treatment phase', 'timeFrame': 'From 2nd randomization to progression or death of any cause (every 2 cycles (6 weeks) during study treatment, and then every 8 weeks during follow-up period)'}], 'secondaryOutcomes': [{'measure': 'Disease control rate (DCR) during the first line treatment phase', 'timeFrame': 'Every 2 cycles (6 weeks)'}, {'measure': 'Overall response rate (ORR) during the first line treatment phase', 'timeFrame': 'Every 2 cycles (6 weeks)'}, {'measure': 'Time to disease progression (TTP) during the maintenance treatment phase', 'timeFrame': 'From 2nd randomization up to disease progression (every 2 cycles (6 weeks))'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'From 1st randomization to death of any cause (every 2 cycles (6 weeks) during study treatment, and then every 8 weeks during follow-up period)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lung Neoplasms']}, 'referencesModule': {'references': [{'pmid': '33708965', 'type': 'DERIVED', 'citation': 'Zhang L, Lu S, Cheng Y, Hu Z, Wu YL, Chen Z, Chen G, Liu X, Yang J, Zhang L, Chen J, Huang M, Tao M, Cheng G, Huang C, Zhou C, Zhang W, Zhao H, Sun Y. Docetaxel maintenance therapy versus best supportive care after first-line chemotherapy with different dose docetaxel plus cisplatin for advanced non-small cell lung cancer (TFINE study, CTONG-0904): an open-label, randomized, phase III trial. Ann Transl Med. 2021 Feb;9(4):338. doi: 10.21037/atm-20-8078.'}]}, 'descriptionModule': {'briefSummary': 'The Primary Objective is to evaluate the progression-free survival (PFS).\n\nThe secondary objectives are:\n\n* To compare the disease control rates of different doses of Docetaxel+Cisplatin as first-line treatment according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria;\n* To evaluate the overall response rate (ORR);\n* To evaluate the time to disease progression (TTP);\n* To evaluate the overall survival (OS);\n* To evaluate the toxicity.', 'detailedDescription': 'The study consists in:\n\n* A first line treatment phase: participants receive 4 cycles of chemotherapy (each cycle contains 3 weeks) with either docetaxel (75 mg/m2) plus cisplatin (75 mg/m2) or docetaxel (60 mg/m2) plus cisplatin (75 mg/m2) ,\n* A maintenance treatment phase: participants with disease control (complete response \\[CR\\], partial response \\[PR\\] or stable disease \\[SD\\]) after the initial treatment receive up to 6 cycles of chemotherapy with docetaxel (60 mg/m2) or best supportive care (BSC).\n* A follow-up period from the end of study treatment until participant death or end of study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Histologic or cytologic diagnosis of advanced non-small-cell lung cancer (NSCLC)\n* Based on International Association for the Study of Lung Cancer (IASLC) 2009 new Tumor-Node-Metastasis (TNM) stage criteria of lung cancer, local advanced stage IIIB (not applicable for radical radiation therapy) disease or metastatic stage IV disease or recurrent disease\n* At least one evaluable tumor lesion based on RECIST criteria (\\>= 20 mm with conventional techniques or \\>= 10 mm with spiral Computed Tomography scan)\n* Eastern Cooperative Oncology Group performance status (ECOG PS) 0/1\n* Adequate bone marrow reserve\n\n * absolute neutrophil count \\>= 2.0×10\\^9/L\n * platelets \\>= 100×10\\^9/L\n * hemoglobin \\>= 9.0 g/dL\n* Adequate hepatic function\n\n * total bilirubin \\<= Upper Normal Limit (UNL)\n * Aspartate Amino Transferase (AST), Alanine Amino Transferase (ALT) \\<= 2.5 UNL\n * alkaline phosphatase (ALP) \\<= 5 UNL\n* Adequate renal function (serum creatinine \\<= UNL or creatinine clearance \\>= 60 mL/min)\n* No prior chemotherapy was allowed or only (neo) adjuvant chemotherapy ended more than 6 months before treatment (patients should not have been heavily pre-treated, the maximum cumulative dose of cisplatin allowed is 350 mg/m²)\n* Prior surgery was permitted only if the operation performed more than 4 weeks ago and the patient was completely recovery\n* Childbearing potential either terminated or attenuated by the use of an approved contraceptive method\n* Inform consent signed\n\nExclusion criteria:\n\n* Other tumour type than advanced / metastatic NSCLC in recent 5 years (except cone-biopsied carcinoma-in-situ of the cervix or adequately treated basal or squamous cell carcinoma of the skin).\n* Presence of symptomatic central nervous system metastases\n* Inadequate liver function\n\n * total bilirubin \\> 1 UNL\n * ALT and/or AST\\>1.5 UNL associated with alkaline phosphatase \\> 2.5 UNL\n * inadequate renal function (creatinine \\> 1.0 times UNL and in case of limit value, creatinine clearance \\< 60 mL/min)\n* Prior radiation therapy, or surgery operation within 4 weeks\n* Prior use of taxoids\n* Active infection, or serious concomitant systemic disorder incompatible with the study\n* Childbearing potential but unwilling to use of an approved contraceptive method\n* Receive treatment from other clinical trials during this study treatment\n* History of hypersensitivity to any of study medication\n* Other serious concomitant abnormal or illness\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01038661', 'acronym': 'TFINE', 'briefTitle': 'Tax First-line Chemotherapy With Different Doses and Then Maintenance Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Randomized, Controlled Study Comparing the Efficacy and Safety of Docetaxel （60mg/m2）Maintenance Treatment vs. Best Supportive Care Following First Line Chemotherapy With Different Doses of Docetaxel（75/60mg/m2）in Combination With Cisplatin in Patients With Local Advanced or Metastatic （Stage IIIB/IV）Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'DOCET_L_04827'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²', 'description': 'Docetaxel 75 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles', 'interventionNames': ['Drug: Docetaxel', 'Drug: Cisplatin']}, {'type': 'EXPERIMENTAL', 'label': 'First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²', 'description': 'Docetaxel 60 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles', 'interventionNames': ['Drug: Docetaxel', 'Drug: Cisplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Maintenance treatment: docetaxel (60 mg/m2)', 'description': 'Docetaxel 60 mg/m² on day 1, repeated every 3 weeks until progressive disease or up to 6 cycles', 'interventionNames': ['Drug: Docetaxel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Maintenance treatment: best supportive care (BSC)', 'description': 'BSC until progressive disease', 'interventionNames': ['Other: Best supportive care (BSC)']}], 'interventions': [{'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere®'], 'description': 'Formulation: concentrated solution for intravenous infusion (IV)\n\nRoute(s) of administration: 1-hour IV', 'armGroupLabels': ['First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²', 'First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²', 'Maintenance treatment: docetaxel (60 mg/m2)']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Formulation: concentrated solution for intravenous infusion (IV)\n\nRoute(s) of administration: 1-3-hour IV', 'armGroupLabels': ['First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²', 'First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²']}, {'name': 'Best supportive care (BSC)', 'type': 'OTHER', 'description': 'Any treatment including palliative radiotherapy for pain relief-but not chemotherapy - that is considered appropriate by the investigator', 'armGroupLabels': ['Maintenance treatment: best supportive care (BSC)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}