Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-26 @ 7:24 PM
Study NCT ID:
NCT03108560
Status:
UNKNOWN
Last Update Posted:
2018-09-07
First Post:
2017-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sublobar Resection Versus Lobectomy for cT1N0M0 Non-small-cell Lung Cancer
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': 'D038481', 'term': 'Anterior Temporal Lobectomy'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-05', 'studyFirstSubmitDate': '2017-03-28', 'studyFirstSubmitQcDate': '2017-04-05', 'lastUpdatePostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'five years after surgery', 'description': 'survival status of patients after surgery'}], 'secondaryOutcomes': [{'measure': 'Disease Free Survival', 'timeFrame': 'five years after surgery', 'description': 'recurrence status of patients after surgery'}, {'measure': 'Local and distant recurrence rates', 'timeFrame': 'five years after surgery', 'description': 'recurrence rate of local and distant locations respectively'}, {'measure': 'Pulmonary Function: forced expiratory volume in 1 second (FEV1) in liter', 'timeFrame': '3rd, 6th, 12th, and 24th month after surgery', 'description': 'FEV1 of patients after surgery'}, {'measure': 'Pulmonary Function: forced vital capacity (FVC) in liter', 'timeFrame': '3rd, 6th, 12th, and 24th month after surgery', 'description': 'FVC of patients after surgery'}, {'measure': 'Pulmonary Function: diffusing capacity of the lungs for carbon monoxide (DLCO) in mL/min/mmHg', 'timeFrame': '3rd, 6th, 12th, and 24th month after surgery', 'description': 'DLCO of patients after surgery'}, {'measure': 'Morbidity rate', 'timeFrame': 'up to 30 days after surgery', 'description': 'the rates of complications related to treatment during perioperative period'}, {'measure': 'Mortality rate', 'timeFrame': 'up to 30 days after surgery', 'description': 'the rates of death related to treatment during perioperative period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sublobar resection', 'lobectomy'], 'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'The incidence rate of ground-glass opacity (GGO) has been increasing these years. A great number of retrospective studies suggested that sublobar resection was better for some GGO patients. However, no prospective clinical study supports the perspective. This study is prospective, multi-center, randomized-controlled. The aim of this study is to investigate whether sublobar resection is inferior to lobectomy for cT1N0M0 non-small-cell lung cancer or not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cT1N0M0 non-small-cell lung cancer\n* ground-glass opacity, ≤2cm, GGO≥25%\n* eligible for both lobectomy and sublobar resection\n* intraoperative pathology is minimally-invasive adenocarcinoma or invasive adenocarcinoma\n* intraoperative pathology of biopsied station 10 lymph node is negative\n\nExclusion Criteria:\n\n* intraoperative pathology is benign nodule, atypical adenomatous hyperplasia, or adenocarcinoma in-situ\n* intraoperative pathology of biopsied station 10 lymph node is positive\n* multiple GGOs, lesions other than dominant lesion are malignant or \\>5mm\n* history of thoracic surgery\n* history of malignancy in recent 5 years\n* unstable systemic disease\n* patients with psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT03108560', 'briefTitle': 'Sublobar Resection Versus Lobectomy for cT1N0M0 Non-small-cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'A Multi-center, Randomized-controlled, Open-label Clinical Trial: Sublobar Resection Versus Lobectomy for cT1N0M0 Non-small-cell Lung Cancer', 'orgStudyIdInfo': {'id': 'ZSTS201701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sublobar group', 'description': 'Patients receive sublobar resection, including wedge resection and segmentectomy.', 'interventionNames': ['Procedure: sublobar resection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lobectomy group', 'description': 'Patients receive lobectomy.', 'interventionNames': ['Procedure: lobectomy']}], 'interventions': [{'name': 'sublobar resection', 'type': 'PROCEDURE', 'description': 'Patients receive sublobar resection, which includes wedge resection and segmentectomy.', 'armGroupLabels': ['Sublobar group']}, {'name': 'lobectomy', 'type': 'PROCEDURE', 'description': 'patients receive lobectomy', 'armGroupLabels': ['Lobectomy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Di Ge, MD', 'role': 'CONTACT', 'email': 'ge.di@zs-hospital.sh.cn', 'phone': '13681975917'}], 'facility': 'Shanghai Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Junjie Xi, MD', 'role': 'CONTACT', 'email': 'xi.junjie@zs-hospital.sh.cn', 'phone': '8602164041990', 'phoneExt': '2017'}], 'overallOfficials': [{'name': 'Di Ge, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The data of all case report forms are to be collected and shared with other researchers at the end of followup.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ruijin Hospital', 'class': 'OTHER'}, {'name': 'RenJi Hospital', 'class': 'OTHER'}, {'name': 'Fujian Medical University Union Hospital', 'class': 'OTHER'}, {'name': 'The Second Affiliated Hospital of Dalian Medical University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, {'name': 'Ningbo No.2 Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}