Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
Study NCT ID:
NCT00912392
Status:
COMPLETED
Last Update Posted:
2014-09-03
First Post:
2009-06-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Etoposide-Carboplatin Alone or With Endostar for Extensive Disease Small Cell Lung Cancer (ED-SCLC)
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': 'C522911', 'term': 'endostar protein'}, {'id': 'C098534', 'term': 'EC regimen'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-31', 'studyFirstSubmitDate': '2009-06-01', 'studyFirstSubmitQcDate': '2009-06-02', 'lastUpdatePostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': 'Oct-30-2012'}], 'secondaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'at 6 months'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Oct-30-2012'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'Oct-30-2012'}, {'measure': 'Clinical benefit rate (CBR)', 'timeFrame': 'Oct-30-2012'}, {'measure': 'Response duration', 'timeFrame': 'Oct-30-2012'}, {'measure': 'Time to progression(TTP)', 'timeFrame': 'Oct-30-2012'}, {'measure': 'Quality of life (QOL)', 'timeFrame': 'Oct-30-2012'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Background:\n\nThe effect of existing treatment modalities of extensive disease small-cell lung cancer (ED-SCLC) is unsatisfactory. Progress of new strategies including more efficient therapy is wanted. Endostar® (Rh-endostatin Injection) may have anti-tumor activity by against vascular endothelial growth factor for initial treatment. This study was designed to evaluate the safety and efficacy of Endostar® combined with etoposide-carboplatin (EC) chemotherapy in patients with ED-SCLC seeking for more effective treatment.', 'detailedDescription': 'Methods:\n\nIn this randomized, open label, placebo-controlled, multicentre trial, 120 patients are planned to be enrolled at random into 2 arms(1:1) from 10 centers between June 2009 and June 2011. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong University. Main eligibility criteria are histological or cytological diagnosis of ED-SCLC, with an age of 18-75 years. All eligible patients receive etoposide-carboplatin (EC) alone or with endostar® for 4-6 cycles (21 days for 1 cycle). In arm1 patients receive endostar® 7.5mg/m2 on day 1 to day 14, etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1. In arm2 patients receive etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.\n\nPrimary endpoint: progress free survival (PFS).\n\nSecondary endpoint: progress free survival at 6 months, overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), Response duration, time to progression(TTP) and quality of life (QOL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically diagnosed SCLC;\n* Age of 18-75 years;\n* Life expectancy \\> 3 months;\n* Adequate hematologic, renal, and hepatic function;\n* ECOG PS 0-2;\n\nExclusion Criteria:\n\n* Brain metastases;\n* Clinically significant cardiovascular disease;\n* Presence of hepatic and renal dysfunction;\n* Evidence of bleeding diathesis or coagulopathy\n* Pregnant or lactating woman;'}, 'identificationModule': {'nctId': 'NCT00912392', 'briefTitle': 'Etoposide-Carboplatin Alone or With Endostar for Extensive Disease Small Cell Lung Cancer (ED-SCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd'}, 'officialTitle': 'Etoposide-Carboplatin (EC) Versus EC Plus Endostar in Patients With Extensive Disease Small Cell Lung Cancer (ED-SCLC): Randomized, Open Label, Placebo-controlled, Multicentre Study', 'orgStudyIdInfo': {'id': 'SIM-69'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etoposide-Carboplatin with Endostar', 'description': 'Endostar® 7.5mg/m2 on day 1 to day 14, etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.', 'interventionNames': ['Drug: Endostar', 'Drug: Etoposide-Carboplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Etoposide-Carboplatin', 'description': 'Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.', 'interventionNames': ['Drug: Etoposide-Carboplatin']}], 'interventions': [{'name': 'Endostar', 'type': 'DRUG', 'description': 'Endostar® 7.5mg/m2 on day 1 to day 14', 'armGroupLabels': ['Etoposide-Carboplatin with Endostar']}, {'name': 'Etoposide-Carboplatin', 'type': 'DRUG', 'description': 'Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.', 'armGroupLabels': ['Etoposide-Carboplatin', 'Etoposide-Carboplatin with Endostar']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200039', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Shun Lu, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Chest Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}