Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-28 @ 2:07 PM
Study NCT ID:
NCT00940069
Status:
COMPLETED
Last Update Posted:
2016-02-22
First Post:
2009-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TS Gene Polymorphism Predicts Effect in Patients With Advanced Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial 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'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068437', 'term': 'Pemetrexed'}], 'ancestors': [{'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-19', 'studyFirstSubmitDate': '2009-07-14', 'studyFirstSubmitQcDate': '2009-07-14', 'lastUpdatePostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to progress', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['TS', 'polymorphism', 'lung cancer', 'adenocarcinoma', 'pemetrexed'], 'conditions': ['Non-small-cell Lung Cancer', 'Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '25028118', 'type': 'RESULT', 'citation': 'Krawczyk P, Kucharczyk T, Kowalski DM, Powrozek T, Ramlau R, Kalinka-Warzocha E, Winiarczyk K, Knetki-Wroblewska M, Wojas-Krawczyk K, Kalakucka K, Dyszkiewicz W, Krzakowski M, Milanowski J. Polymorphisms in TS, MTHFR and ERCC1 genes as predictive markers in first-line platinum and pemetrexed therapy in NSCLC patients. J Cancer Res Clin Oncol. 2014 Dec;140(12):2047-57. doi: 10.1007/s00432-014-1756-6. Epub 2014 Jul 16.'}, {'pmid': '23350714', 'type': 'RESULT', 'citation': "Wang X, Wang Y, Wang Y, Cheng J, Wang Y, Ha M. Association of thymidylate synthase gene 3'-untranslated region polymorphism with sensitivity of non-small cell lung cancer to pemetrexed treatment: TS gene polymorphism and pemetrexed sensitivity in NSCLC. J Biomed Sci. 2013 Jan 25;20(1):5. doi: 10.1186/1423-0127-20-5."}]}, 'descriptionModule': {'briefSummary': 'The investigators performed a multicenter, open trial of using TS gene polymorphism to predict advanced lung adenocarcinoma effect to pemetrexed combined with cisplatin regiment as first-line treatment.', 'detailedDescription': '1. Main eligibility criteria were histologic or cytologic proof of advanced non-small-cell lung cancer (NSCLC) primary treatment, normal organ function, and Eastern Cooperative Oncology Group performance status 0 to 2.\n2. All Patients were delivered to pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 for not less than 4 cycle, administered intravenously every 3 weeks. Response assessment was performed every 6 weeks; toxicity assessment was performed every 3 weeks.\n3. Primary end point was time to progression (TTP); secondary end points were objective response rate (ORR), overall survival (OS), and toxicity.\n4. The study was designed to evaluate TS(thymidylate synthase) gene polymorphism as a predictor for advanced lung adenocarcinoma effect to pemetrexed combined with cisplatin regiment as first-line treatment.\n5. Polymorphisms of thymidylate synthase were investigated in peripheral WBC（white blood cell）of all patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologic or cytologic proof of advanced lung adenocarcinoma\n* primary treatment\n* normal organ function\n* Eastern Cooperative Oncology Group performance status 0 to 2\n\nExclusion Criteria:\n\n* Symptomatic patients with brain metastases\n* Major organ dysfunction and severe heart disease'}, 'identificationModule': {'nctId': 'NCT00940069', 'acronym': 'TPEIAL', 'briefTitle': 'TS Gene Polymorphism Predicts Effect in Patients With Advanced Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hunan Province Tumor Hospital'}, 'officialTitle': 'A Multicenter, Open Clinical Trial of Using TS Gene Polymorphism to Predict Effect in Patients of Advanced Lung Adenocarcinoma to Pemetrexed Combining With Cisplatin Regiment as First-line Treatment', 'orgStudyIdInfo': {'id': 'LYN-LC-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TS high expression genotype', 'description': 'TS high expression genotype delivered to pemetrexed 500 mg/m2 and cisplatin 75 mg/m2,for not less than 4 cycle, administered intravenously every 3 weeks.', 'interventionNames': ['Drug: pemetrexed']}, {'type': 'EXPERIMENTAL', 'label': 'TS low expression genotype', 'description': 'TS low expression genotype delivered to pemetrexed 500 mg/m2 and cisplatin 75 mg/m2,for not less than 4 cycle, administered intravenously every 3 weeks.', 'interventionNames': ['Drug: pemetrexed']}], 'interventions': [{'name': 'pemetrexed', 'type': 'DRUG', 'otherNames': ['Alimta'], 'description': "'TS high expression genotype': pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of each 21 day,for not less than 4 cycle, administered intravenously every 3 weeks.\n\n'TS low expression genotype': pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of each 21 day,for not less than 4 cycle, administered intravenously every 3 weeks.", 'armGroupLabels': ['TS high expression genotype', 'TS low expression genotype']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'HuNan province tumor hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'overallOfficials': [{'name': 'Yi Luo, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Hunan Province Tumor Hospital'}, {'name': 'Nong Yang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hunan Province Tumor Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunan Province Tumor Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director', 'investigatorFullName': 'Yi Luo', 'investigatorAffiliation': 'Hunan Province Tumor Hospital'}}}}