Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-18 @ 1:37 PM
Study NCT ID:
NCT00286169
Status:
TERMINATED
Last Update Posted:
2022-04-12
First Post:
2006-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amrubicin Study for Elderly Patients With 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': 'C055866', 'term': 'amrubicin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'lastUpdateSubmitDate': '2022-04-09', 'studyFirstSubmitDate': '2006-02-01', 'studyFirstSubmitQcDate': '2006-02-01', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-02-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival'}], 'secondaryOutcomes': [{'measure': 'Time to progression'}, {'measure': 'Objective tumor response'}, {'measure': 'Quality of Life (QOL: EuroQOL, FACT-L-LCS)'}, {'measure': 'Frequency and severity of adverse events'}]}, 'conditionsModule': {'keywords': ['Extensive-disease small-cell lung cancer (ED-SCLC)'], 'conditions': ['Small-cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy and toxicity of amrubicin with carboplatin plus etoposide in elderly patients with extensive-disease small-cell lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Extensive-disease small-cell lung cancer\n* Aged 70 years or older\n* Performance status of 0-2\n* No prior chemotherapy\n\nExclusion Criteria:\n\n* Prior therapy for primary lesion\n* Pneumonitis and/or pulmonary fibrosis\n* Active concomitant malignancy'}, 'identificationModule': {'nctId': 'NCT00286169', 'briefTitle': 'Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sumitomo Pharma Co., Ltd.'}, 'officialTitle': 'Randomized Phase III Trial of Amrubicin Versus Carboplatin Plus Etoposide in Elderly Patients With Extensive-disease Small-cell Lung Cancer', 'orgStudyIdInfo': {'id': 'D0702002'}, 'secondaryIdInfos': [{'id': 'JapicCTI-060203'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Amrubicin Hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chugoku', 'country': 'Japan', 'facility': 'Chugoku Region Site'}, {'city': 'Chūbu', 'country': 'Japan', 'facility': 'Chubu Region Site', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido Region Site'}, {'city': 'Kanto', 'country': 'Japan', 'facility': 'Kanto Region Site'}, {'city': 'Kinki', 'country': 'Japan', 'facility': 'Kinki Region Site'}, {'city': 'Kyushu', 'country': 'Japan', 'facility': 'Kyushu Region Site'}, {'city': 'Shikoku', 'country': 'Japan', 'facility': 'Shikoku Region Site'}, {'city': 'Tōhoku', 'country': 'Japan', 'facility': 'Tohoku Region Site', 'geoPoint': {'lat': 35.81882, 'lon': 139.57138}}], 'overallOfficials': [{'name': 'Drug Development Division', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sumitomo Pharma Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sumitomo Pharma Co., Ltd.', 'class': 'INDUSTRY'}}}}