Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-06 @ 7:46 PM
Study NCT ID:
NCT00265694
Status:
UNKNOWN
Last Update Posted:
2005-12-15
First Post:
2005-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Random Trial for Elderly Patients With NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-06', 'lastUpdateSubmitDate': '2005-12-14', 'studyFirstSubmitDate': '2005-12-14', 'studyFirstSubmitQcDate': '2005-12-14', 'lastUpdatePostDateStruct': {'date': '2005-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-15', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': '1. Recently a radomized trial of vinorelbine versus best supportive care in patients at 70 years of age or older demonstrated a definite improvement in overall survival rate and quality of life with chemotherapy.\n2. The role of combination therapy containing the platinum compound, which is the standard therapy for the young patients is still vague.\n3. Gemcitabine and carboplatin have favorable toxicity profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with pathologically confirmed, advanced(clinical stage IIIB or IV) NSCLC\n* No previous chemotherapy history\n* Age ≥ 65 years\n* ECOG performance status ≤ 2\n* Adequate marrow function (ANC ≥ 2,000/mm3, platelet ≥ 100,000/mm3), renal and liver function (total bilirubin \\< 2.0 mg/dL, AST/ALT levels \\< 3 × the upper limit of normal, serum creatinine \\< 2.0 mg/dL)\n* Patients with informed written consent\n\nExclusion Criteria:\n\n* Patients with other major illness(active infection, severe heart disease, concomitant malignancy, etc)'}, 'identificationModule': {'nctId': 'NCT00265694', 'briefTitle': 'Random Trial for Elderly Patients With NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'A Randomized Phase III Trial of Vinorelbine Versus Gemcitabine and Carboplatin for Elderly Patients With Advanced Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'INJE05-06'}}, 'armsInterventionsModule': {'interventions': [{'name': 'vinorelbine, gemcitabine and carboplatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '139-707', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young Jin Yuh, M.D.', 'role': 'CONTACT', 'email': 'yjyuh@sanggyepaik.ac.kr', 'phone': '82-2-950-1460'}, {'name': 'Young Jin Yuh, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Inje University Sanggyepaik Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Young Jin Yuh, M.D.', 'role': 'CONTACT', 'email': 'yjyuh@sanggyepaik.ac.kr', 'phone': '82-2-950-1460'}], 'overallOfficials': [{'name': 'Young Jin Yuh, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}}}}