Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-22 @ 7:05 AM
Study NCT ID:
NCT03613467
Status:
COMPLETED
Last Update Posted:
2018-08-09
First Post:
2018-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Video-assisted Thoracoscopic Lobectomy a Clinical Alternative for Surgically Resectable Pathologic N2 NSCLC Patients
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2145}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2018-07-16', 'studyFirstSubmitQcDate': '2018-07-27', 'lastUpdatePostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall survivals in the subgroups stratified by T staging', 'timeFrame': '2014-2018', 'description': 'Overall survivals in the subgroups stratified by T staging'}, {'measure': 'Overall survivals in the subgroups stratified by neoadjuvant therapy', 'timeFrame': '2014-2018', 'description': 'Overall survivals in the subgroups stratified by neoadjuvant therapy'}, {'measure': 'Overall survivals in the subgroups stratified by number of lymph node station involved', 'timeFrame': '2014-2018', 'description': 'Overall survivals in the subgroups stratified by number of lymph node station involved'}, {'measure': 'Impact factors for overall survival', 'timeFrame': '2014-2018', 'description': 'Impact factors for overall survival'}, {'measure': 'Impact factors for postoperative mortality within 30/90 days', 'timeFrame': '2014-2017', 'description': 'Impact factors for postoperative mortality within 30/90 days'}, {'measure': 'Propensity score matching analysis of overall survival', 'timeFrame': '2014-2018', 'description': 'Propensity score matching analysis of overall survival'}, {'measure': 'Propensity score matching analysis of perioperative outcomes', 'timeFrame': '2014-2018', 'description': 'Propensity score matching analysis of perioperative outcomes'}, {'measure': 'Propensity score matching analysis of impact factors for overall survival', 'timeFrame': '2014-2018', 'description': 'Propensity score matching analysis of impact factors for overall survival'}, {'measure': 'Propensity score matching analysis of impact factors for postoperative mortality within 30/90 days', 'timeFrame': '2014-2018', 'description': 'Propensity score matching analysis of impact factors for postoperative mortality within 30/90 days'}], 'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2014-2018', 'description': 'Overall survival'}], 'secondaryOutcomes': [{'measure': 'Duration of hospital stay [Perioperative outcomes]', 'timeFrame': '2014-2017', 'description': 'Duration of hospital stay \\[Perioperative outcomes\\]'}, {'measure': 'Postoperative 30 and 90 days [Perioperative outcomes]', 'timeFrame': '2014-2017', 'description': 'Postoperative 30 and 90 days \\[Perioperative outcomes\\]'}, {'measure': 'Drainage time [Perioperative outcomes]', 'timeFrame': '2014-2017', 'description': 'Drainage time \\[Perioperative outcomes\\]'}, {'measure': 'Intraoperative blood loss [Perioperative outcomes]', 'timeFrame': '2014-2017', 'description': 'Intraoperative blood loss \\[Perioperative outcomes\\]'}, {'measure': 'Postoperative complications [Perioperative outcomes]', 'timeFrame': '2014-2017', 'description': 'Postoperative complications \\[Perioperative outcomes\\]'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vedio-assisted thoracoscopic lobectomy', 'Thoracotomy lobectomy', 'Real-world evidences;', 'pN2 NSCLC'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The study was designed to compare the safety and effectiveness of vedio-assisted thoracoscopic lobectomy with open lobectomy for patients with surgically resectable pathologic N2 non-small cell lung cancer', 'detailedDescription': 'The is a multi-center retrospective study. Patients with pathologic N2 NSCLC who underwent VATS or open lobectomy between 2014 and 2017 were included into this study. Clinical data on patient demographic, clinical characteristics, treatment and clinical outcomes will be collected to evaluate the safety and effectiveness of video-assisted thoracoscopic lobectomy for pathologic N2 NSCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pathologically diagnosed N2 non-small cell lung cancer who received VATS or thoracotomy lobectomy between 2014 and 2017', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with age \\> 18 years old;\n* Patients with pathologically diagnosed non-small cell lung cancer;\n* Patients underwent lobectomy by either VATS or thoracotomy between 2014 and 2017;\n* Patients who received lymphadenectomy for all accessible lymph nodes;\n* Patients with N2 lymph nodes (+) after surgeries;\n\nExclusion Criteria:\n\n* Patients with second primary tumors or multiple primary tumors;\n* Patients who received chest surgeries before hospitalization;\n* Patients with superior pulmonary sulcus tumor'}, 'identificationModule': {'nctId': 'NCT03613467', 'briefTitle': 'Is Video-assisted Thoracoscopic Lobectomy a Clinical Alternative for Surgically Resectable Pathologic N2 NSCLC Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tang-Du Hospital'}, 'officialTitle': 'Vedio-assisted Thoracoscopic Lobectomy vs Open Lobectomy for Patients With Surgically Resectable Pathologic N2 NSCLC', 'orgStudyIdInfo': {'id': 'W-TONG06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VATS lobectomy', 'description': 'Pathologic N2 NSCLC patients who received lobectomy by video-assisted thoracoscopic surgery', 'interventionNames': ['Procedure: VATS lobectomy']}, {'label': 'Thoracotomy lobectomy', 'description': 'Pathologic N2 NSCLC patients who received lobectomy by thoracotomy', 'interventionNames': ['Procedure: Thoracotomy lobectomy']}], 'interventions': [{'name': 'VATS lobectomy', 'type': 'PROCEDURE', 'description': 'Patients who received lobectomy by video-assisted thoracoscopic surgery', 'armGroupLabels': ['VATS lobectomy']}, {'name': 'Thoracotomy lobectomy', 'type': 'PROCEDURE', 'description': 'Patients who received lobectomy by thoracotomy', 'armGroupLabels': ['Thoracotomy lobectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'China PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital Affiliated to Huazhong Technology Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu cancer hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '710000', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': "Xi'an Tangdu Hospital", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Huaxi Hospital Affiliated to Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300051', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Chest Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'First Hospital Affiliated to Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Xiaofei Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tang-Du Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'LinkDoc Technology (Beijing) Co. Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'lixiaofei', 'investigatorAffiliation': 'Tang-Du Hospital'}}}}