Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2025-12-27 @ 9:55 PM
Study NCT ID:
NCT01130961
Status:
COMPLETED
Last Update Posted:
2010-10-07
First Post:
2010-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Advanced Non-Small Cell Lung Cancer (NSCLC) and Clinical Outcomes in Patients Who Received Gefitinib in Thailand
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-06', 'studyFirstSubmitDate': '2010-04-29', 'studyFirstSubmitQcDate': '2010-05-25', 'lastUpdatePostDateStruct': {'date': '2010-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'median time from the first date of treatment until date of disease progression during Jan 2004- Dec 2008 or 5 years approx.'}], 'secondaryOutcomes': [{'measure': 'Time to maximum response', 'timeFrame': 'Median time from the first date of treatment until the date that the disease can be maximum controlled during Jan 2004- Dec 2008 or 5 years approx.'}, {'measure': 'Overall survival', 'timeFrame': 'time from the first date of treatment until date of patients dead during Jan 2004- Dec 2008 or 5 years approx.'}, {'measure': 'Prevalence of EGFR & KRAS mutation from laboratory result', 'timeFrame': 'During Jan 2004- Dec 2008 or 5 years approx.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced NSCLC', 'Gefitinib', 'Thai patient'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine progression-free survival of lung cancer patients who received gefitinib in clinical practice in Thailand.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Lung cancer patients admitted in Chulalongkorn and Siriraj hospitals between January 2004 and December 2008 and treated with gefitinib for at least 3 months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed as having lung cancer based on histological/cytological findings\n* Admitted to the hospital between January 2004 and December 2008\n* Treated with gefitinib for at least 3 months\n\nExclusion Criteria:\n\n* Involvement in the planning and/or conduct of the study\n* Participation in another clinical study during the last 3 months'}, 'identificationModule': {'nctId': 'NCT01130961', 'briefTitle': 'Management of Advanced Non-Small Cell Lung Cancer (NSCLC) and Clinical Outcomes in Patients Who Received Gefitinib in Thailand', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Management of Advanced Non-Small Cell Lung Cancer and Clinical Outcomes in Patients Who Received Gefitinib (IRESSA) in Tertiary Care Setting in Thailand', 'orgStudyIdInfo': {'id': 'NIS-OTH-IRE-2009/1'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Research Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Virote Sriuranpong, MD., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulalongkorn Hospital, Bangkok, Thailand'}, {'name': 'Vichien Srimuninnimit, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siriraj Hospital, Bangkok, Thailand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'MC MD', 'oldOrganization': 'AstraZeneca'}}}}