Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT01282151
Status:
TERMINATED
Last Update Posted:
2015-07-14
First Post:
2011-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-08-21', 'releaseDate': '2015-07-27'}, {'resetDate': '2021-08-24', 'releaseDate': '2021-08-01'}], 'estimatedResultsFirstSubmitDate': '2015-07-27'}}, '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': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000068437', 'term': 'Pemetrexed'}], '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'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'whyStopped': 'Difficulty in recruitment due to approval of maintenance pemetrexed treatment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-13', 'studyFirstSubmitDate': '2011-01-21', 'studyFirstSubmitQcDate': '2011-01-21', 'lastUpdatePostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'one year', 'description': 'months after beginning of first cycle chemotherapy'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (months from the beginning of first cycle chemotherapy)', 'timeFrame': 'three years', 'description': 'months from the beginning of first cycle chemotherapy'}, {'measure': 'Safety Profile', 'timeFrame': 'four months', 'description': 'Toxicity using CTCAE version 4.0'}, {'measure': 'Response rate', 'timeFrame': '6-7th week', 'description': 'Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NSCLC', 'Non Squamous cell', 'Docetaxel', 'Pemetrexed'], 'conditions': ['Carcinoma, Non Small Cell Lung']}, 'descriptionModule': {'briefSummary': 'This study is:\n\n* A multicenter, prospective, randomized, phase 3 trial.\n* To prove non-inferiority of Taxotere/Cisplatin compared to Pemetrexed/Cisplatin as a front line treatment of patients with non-squamous cell lung cancer.\n* 276 patients will be recruited.', 'detailedDescription': 'Docetaxel is being used in 60mg/m2 3 weekly dosage in Japan and several east Asian institutions. Docetaxel 60mg/m2 and Cisplatin 70 mg/m3 3 weekly regimen will be compared to Pemetrexed 500mg/m2 and Cisplatin 70 mg/m2 3 weekly regimen in first line NSCLC with non-squamous histology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18 years old\n* ECOG performance status 0-2\n* Non-squamous cell type non-small cell lung cancer (NSCLC)\n* Stage IV, Stage IIIB cannot be treated with curative intent or Relapsed after surgery or radiation therapy\n* No prior chemotherapy except adjuvant chemotherapy and concurrent chemoradiation treatment. The last dose of adjuvant chemotherapy should be at least 6 months earlier from randomization, and the regimen should not contain docetaxel or pemetrexed.\n* No prior immunotherapy, biologic therapy\n* Measurable lesion with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1\n* Hemoglobin \\>=9.0g/dl, Platelet \\>=100,000/uL, neutrophil \\>=1,500 /uL Creatinine \\<=1.5 x upper normal limit or creatinine clearance \\>=60 mL/min Bilirubin \\<=1.5 x upper normal limit, Transaminases \\<=2 x upper normal limit Alkaline phosphatase \\<=2 x upper normal limit\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy, Lactating woman\n* Woman in child bearing age who refuses to do pregnancy test\n* Moderate or greater than grade 1 motor or sensory neurotoxicity\n* Hypersensitivity to taxane\n* Comorbidity or poor medical conditions\n* Other malignancy (except cured basal cell carcinoma or uterine cervical carcinoma in situ)\n* Concurrent treatment with other investigational drugs within 30 days before randomization\n* Active treatment with other anticancer chemotherapy\n* EGFR mutation (exon 19 deletion, L858R, L861Q, G719A/C/S)'}, 'identificationModule': {'nctId': 'NCT01282151', 'acronym': 'TRAIL', 'briefTitle': 'TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Chonnam National University Hospital'}, 'officialTitle': 'A Randomized Phase III Study of TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer', 'orgStudyIdInfo': {'id': 'DOCET_L_05478'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Taxotere', 'description': 'Docetaxel plus Cisplatin', 'interventionNames': ['Drug: Taxotere']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pemetrexed', 'description': 'Pemetrexed plus Cisplatin', 'interventionNames': ['Drug: Pemetrexed']}], 'interventions': [{'name': 'Taxotere', 'type': 'DRUG', 'otherNames': ['Taxotere(R)', 'Cisplatin'], 'description': 'Docetaxel 60 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks', 'armGroupLabels': ['Taxotere']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'otherNames': ['Alimta (R)', 'Cisplatin'], 'description': 'Pemetrexed 500 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks', 'armGroupLabels': ['Pemetrexed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '519-709', 'city': 'Hwasun', 'state': 'Jeollanam-do', 'country': 'South Korea', 'facility': 'Chonnam National University Hwasun Hospital', 'geoPoint': {'lat': 35.06125, 'lon': 126.98746}}, {'city': 'Daegu', 'state': 'Kyungpook', 'country': 'South Korea', 'facility': 'Kyungpook National University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Anyang', 'country': 'South Korea', 'facility': 'Hallym University Medical Center', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'zip': '330-715', 'city': 'Cheonan', 'country': 'South Korea', 'facility': 'Dankook University Hospital', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'zip': '700-712', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Yeungnam Univeristy Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chosun University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Iksan', 'country': 'South Korea', 'facility': 'Wonkwang University Hospital', 'geoPoint': {'lat': 35.94389, 'lon': 126.95444}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '602-739', 'city': 'Pusan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Kosin University Gospel Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'zip': '143-729', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk university medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea Cancer Center Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Wŏnju', 'country': 'South Korea', 'facility': 'Wonju Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}], 'overallOfficials': [{'name': 'Young-Chul Kim, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chonnam National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Young-Chul Kim', 'investigatorAffiliation': 'Chonnam National University Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-07-27', 'type': 'RELEASE'}, {'date': '2015-08-21', 'type': 'RESET'}, {'date': '2021-08-01', 'type': 'RELEASE'}, {'date': '2021-08-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Young-Chul Kim, Professor, Chonnam National University Hospital'}}}}