Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT07135856
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sleeve Lobectomy Following Neoadjuvant Therapy in NSCLC
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-08-08', 'studyFirstSubmitQcDate': '2025-08-15', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intraoperative bleeding', 'timeFrame': 'up to 90 days', 'description': 'The intraoperative bleeding will be investigated between open versus MIS sleeve lobectomy as one of the perioperative outcomes, measured in milliliter (mL).'}, {'measure': 'Surgery duration', 'timeFrame': 'up to 90 days', 'description': 'The surgery duration will be investigated between open versus MIS sleeve lobectomy as one of the perioperative outcomes, measured in minute (min).'}, {'measure': 'Postoperative hospital stay', 'timeFrame': 'up to 90 days', 'description': 'The postoperative hospital stay will be investigated between open versus MIS sleeve lobectomy as one of the perioperative outcomes, measured in day.'}, {'measure': 'Postoperative complications', 'timeFrame': 'up to 90 days', 'description': 'The postoperative complications will be investigated between open versus MIS sleeve lobectomy as one of the perioperative outcomes, showed in the number of the participants who occurred postoperative complications (n).'}, {'measure': 'Perioperative mortality', 'timeFrame': 'up to 90 days', 'description': 'The perioperative mortality will be investigated between open versus MIS sleeve lobectomy as one of the perioperative outcomes, showed in the number of the participants who died within 90 days of surgery (n).'}, {'measure': 'Number of dissected lymph nodes', 'timeFrame': 'up to 90 days', 'description': 'The number of dissected lymph nodes will be investigated between open versus MIS sleeve lobectomy as one of the perioperative outcomes (n).'}, {'measure': 'Number of dissected lymph node stations', 'timeFrame': 'up to 90 days', 'description': 'The number of dissected lymph node stations will be investigated between open versus MIS sleeve lobectomy as one of the perioperative outcomes (n).'}, {'measure': 'Margin status', 'timeFrame': 'up to 90 days', 'description': 'The margin status will be investigated between open versus MIS sleeve lobectomy as one of the perioperative outcomes, showed in the number of the participants who had the positive or negative surgical margins (n).'}, {'measure': 'Postoperative ICU Length of Stay', 'timeFrame': 'up to 90 days', 'description': 'The postoperative ICU length stay will be investigating between open versus MlS sleeve lobectomy as one of the perioperative outcomes, measured in days. If no ICU admission occurs, length of stay is recorded as 0 days.'}, {'measure': 'Postoperative chest tube drainage duration', 'timeFrame': 'up to 90 days', 'description': 'The postoperative chest tube drainage duration will be investigating between open versus MlS sleeve lobectomy as one of the perioperative outcomes, measured in days.'}, {'measure': 'Postoperative pain scores', 'timeFrame': 'up to 90 days', 'description': 'The postoperative pain scale will be investigating between open versus MlS sleeve lobectomy as one of the perioperative outcomes, measured with the Numeric Rating Scale (0-10) on postoperative days 1 and 2, and highest score during hospitalization.'}, {'measure': 'Conversion rate to Thoracotomy', 'timeFrame': 'at surgery', 'description': 'The conversion rate from minimally invasive (VATS or RATS) cases to open thoracotomy will be showed in numbers.'}], 'primaryOutcomes': [{'measure': '3-year RFS', 'timeFrame': '3 years', 'description': 'In this study, the investigators will focus on the 3-year recurrence-free survival (RFS) of the participants between the two groups (open vs. MIS) for the comparison of the long-term oncologic outcomes, as the primary outcome.'}], 'secondaryOutcomes': [{'measure': '3-year OS', 'timeFrame': '3 years', 'description': 'The investigators will also focus on the 3-year overall survival (OS) of the participants between the two groups (open vs. MIS) for the comparison of the long-term oncologic outcomes, as the secondary outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer', 'Neoadjuvant Therapy']}, 'descriptionModule': {'briefSummary': 'The goal of this observational, retrospective, multicenter cohort study is to evaluate the surgical and oncologic outcomes of sleeve lobectomy performed via minimally invasive (RATS/VATS) or open thoracotomy approaches in patients with non-small cell lung cancer (NSCLC) who have undergone neoadjuvant therapy, including chemotherapy, immunotherapy, or combination regimens. The main questions this study aims to answer are:\n\n* Does minimally invasive sleeve lobectomy result in comparable or improved perioperative and postoperative outcomes compared to open thoracotomy following neoadjuvant treatment in NSCLC?\n* Does surgical approach influence oncologic endpoints such as margin status, lymph node dissection, recurrence-free survival, and overall survival? This research addresses a critical gap in the thoracic oncology field by evaluating the safety, complexity, and efficacy of advanced surgical techniques in the context of evolving multimodal therapy paradigm. Findings may inform clinical decision-making and optimize patient selection in an era of increasing use of neoadjuvant strategies for resectable NSCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will involve multiple thoracic surgery centers with experience in advanced surgical techniques for lung cancer, including sleeve resections and neoadjuvant management. Each center will contribute anonymized data from eligible cases, in accordance with local ethical approvals and data protection regulations.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed NSCLC\n* Undergoing sleeve lobectomy with curative intent\n* Receipt of neoadjuvant therapy (chemotherapy, immunotherapy, target therapy, etc.)\n* Surgical approach: either minimally invasive (VATS or RATS) or open thoracotomy\n* Availability of complete perioperative and follow-up data (minimum 12-month follow-up or until death)\n* Signed informative consent\n\nExclusion Criteria:\n\n* Sublobar resections (e.g., segmentectomy) or pneumonectomy\n* Absence of neoadjuvant therapy\n* Purely diagnostic surgical procedures\n* Incomplete medical records or lost to follow-up\n* Metastatic (stage IV) disease at time of surgery'}, 'identificationModule': {'nctId': 'NCT07135856', 'briefTitle': 'Sleeve Lobectomy Following Neoadjuvant Therapy in NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'Comparative Analysis of Minimally Invasive and Open Sleeve Lobectomy Following Neoadjuvant Therapy in NSCLC: A Multicenter Retrospective Evaluation of Surgical Outcomes', 'orgStudyIdInfo': {'id': 'ShanghaiChestNeoSleeve'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Thoracotomy sleeve lobectomy', 'description': 'Patients who underwent open sleeve lobectomy following neoadjuvant therapy'}, {'label': 'MIS sleeve lobectomy', 'description': 'Patients who underwent minimally invasive (i.e. VATS and RATS) sleeve lobectomy following neoadjuvant therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinghua Cheng, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'chengxinghua_001@163.com', 'phone': '86+17701681215'}, {'name': 'Zhebing Lin, M.D.', 'role': 'CONTACT', 'email': 'lzb0315@sjtu.edu.cn', 'phone': '86+18957727196'}], 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xinghua Cheng, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'chengxinghua_001@163.com', 'phone': '86+17701681215'}, {'name': 'Zhebing Lin, M.D.', 'role': 'CONTACT', 'email': 'lzb0315@sjtu.edu.cn', 'phone': '86+18957727196'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, {'name': 'University of Padova, Padova, Italy', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Head of Oncology Surgery, Clinical Professor', 'investigatorFullName': 'Xinghua Cheng', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}