Sleeve Lobectomy Following Neoadjuvant Therapy in NSCLC

NCT ID: NCT07135856

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-12-01

Brief Summary

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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

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Conditions

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Lung Cancer Neoadjuvant Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Thoracotomy sleeve lobectomy

Patients who underwent open sleeve lobectomy following neoadjuvant therapy

No interventions assigned to this group

MIS sleeve lobectomy

Patients who underwent minimally invasive (i.e. VATS and RATS) sleeve lobectomy following neoadjuvant therapy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sir Run Run Shaw Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

University of Padova, Padova, Italy

UNKNOWN

Sponsor Role collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xinghua Cheng

Director, Head of Oncology Surgery, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xinghua Cheng, M.D., Ph.D.

Role: CONTACT

Phone: 86+17701681215

Email: [email protected]

Zhebing Lin, M.D.

Role: CONTACT

Phone: 86+18957727196

Email: [email protected]

Facility Contacts

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Xinghua Cheng, M.D., Ph.D.

Role: primary

Zhebing Lin, M.D.

Role: backup

Other Identifiers

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ShanghaiChestNeoSleeve

Identifier Type: -

Identifier Source: org_study_id