Sleeve Lobectomy Following Neoadjuvant Therapy in NSCLC

Not yet recruiting

• Conditions: Lung Cancer; Neoadjuvant Therapy

• Registration Number: NCT07135856
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

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:

* Does minimally invasive sleeve lobectomy result in comparable or improved perioperative and postoperative outcomes compared to open thoracotomy following neoadjuvant treatment in NSCLC?

* 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-08-08
• Study First Submitted QC: 2025-08-15
• Last Update Submitted: 2025-08-15
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22
• Study Start: 2025-09-01
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Age ≥ 18 years
• Histologically confirmed NSCLC
• Undergoing sleeve lobectomy with curative intent
• Receipt of neoadjuvant therapy (chemotherapy, immunotherapy, target therapy, etc.)
• Surgical approach: either minimally invasive (VATS or RATS) or open thoracotomy
• Availability of complete perioperative and follow-up data (minimum 12-month follow-up or until death)
• Signed informative consent

Exclusion Criteria

• Sublobar resections (e.g., segmentectomy) or pneumonectomy
• Absence of neoadjuvant therapy
• Purely diagnostic surgical procedures
• Incomplete medical records or lost to follow-up
• Metastatic (stage IV) disease at time of surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3-year RFS	3 years	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.

Secondary Outcome Measures

Name	Time	Method
3-year OS	3 years	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.