Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-02-21 @ 12:40 PM
Study NCT ID:
NCT02039518
Status:
UNKNOWN
Last Update Posted:
2014-01-17
First Post:
2013-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-15', 'studyFirstSubmitDate': '2013-12-30', 'studyFirstSubmitQcDate': '2014-01-15', 'lastUpdatePostDateStruct': {'date': '2014-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': 'from the first cycle of treatment (day one) to two month after the last cycle'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Progression free Survival'], 'conditions': ['Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to Evaluate and compare safety and efficacy of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients Receiving Etoposide Combined With Platinum Based First-line Chemotherapy', 'detailedDescription': 'from the first cycle of treatment (day one) to two month after the last cycle'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥18 years\n2. PS=0,1,2\n3. Patients who were diagnosed by the histologic, cytologic diagnosis of extensive small cell lung cancer\n4. Patients received Etoposide combined with platinum based first-line chemotherapy 6 cycles and there is evidence show the patent is PR/CR/SD\n5. Expected lifetime\\>12 weeks\n6. Signed written informed consent\n\nExclusion Criteria:\n\nSmall cell lung cancer non small cell hybrid Women during pregnancy or lactation previously treated with two or more than two kinds of treatment Any non remission of \\>CTCAE caused tumor treatment past grade 2 toxicity Ccr\\<30 ml/min (calculated by Cockcroft-Gault formula) hepatic insufficiency：\n\n1. Tbil\\> 1.5×ULN\n2. ALT and AST \\> 2.5×ULN (Patients with liver metastasis\\>5×ULN) Alkaline phosphatase\\>2.5 ×ULN(Patients with liver metastasis\\>5×ULN)\n3. Severe symptomatic heart disease\n4. Symptomatic brain metastases\n5. In the last 5 years have been or are suffering from other histological types of malignant tumor\n6. There are serious or uncontrolled systemic diseases\n7. During the study period planned radiotherapy on target lesion\n8. During the study period, plans to use other antineoplastic therapy\n9. Clinical study on treatment of 30 days beginning period prior to participate in any study drug'}, 'identificationModule': {'nctId': 'NCT02039518', 'briefTitle': 'Study of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Randomized Controlled Trial of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients Receiving Etoposide Combined With Platinum Based First-line Chemotherapy', 'orgStudyIdInfo': {'id': 'WXH-gemcitabine-SCLC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'gemcitabine', 'description': 'gemcitabine 1000mg/m2，d1，d8，Q3W', 'interventionNames': ['Drug: gemcitabine']}, {'type': 'OTHER', 'label': 'observation group', 'description': 'observation', 'interventionNames': ['Other: observation group']}], 'interventions': [{'name': 'gemcitabine', 'type': 'DRUG', 'otherNames': ['gemcitabine 1000mg/m2，d1，d8，Q3W'], 'description': 'gemcitabine 1000mg/m2，d1，d8，Q3W', 'armGroupLabels': ['gemcitabine']}, {'name': 'observation group', 'type': 'OTHER', 'description': 'observation group', 'armGroupLabels': ['observation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wu X hua, doctor', 'role': 'CONTACT', 'email': 'xhwu2011@yahoo.com', 'phone': '13482888167'}], 'facility': 'Cancer hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Wu X Hua, doctor', 'role': 'CONTACT', 'email': 'xhwu2011@yahoo.com', 'phone': '13482888167'}], 'overallOfficials': [{'name': 'WU X HUA, DOCTOR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Chief Physician', 'investigatorFullName': 'Xianghua Wu', 'investigatorAffiliation': 'Fudan University'}}}}