Septum-guided Segmentectomy for 2-3 cm Clinical Stage IA3 Peripheral Non-Small Cell Lung Cancer

Sponsor
Shanghai Chest Hospital
Study ID
NCT07780591
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • septum-guided anatomical segmentectomy — PROCEDURE
    septum-guided anatomical segmentectomy or combined segmentectomy performed for eligible peripheral clinical stage IA3 non-small cell lung cancer. The intersegmental vein and intersegmental septal membrane are used as anatomical landmarks to define the intersegmental plane. Intraoperative lymph node frozen-section biopsy must confirm node-negative (N0) status before segmentectomy proceeds; positive nodal disease leads to lobectomy plus systematic lymph node dissection as standard treatment.

Study Details

This is a single-center, prospective, single-arm, open-label clinical trial evaluating the efficacy and safety of septum-guided segmentectomy in patients with 2-3 cm clinical stage IA3 peripheral non-small cell lung cancer (NSCLC) with a consolidation-to-tumor ratio (CTR) greater than 0.5 and up to 1.0. All eligible participants will undergo planned septum-guided anatomical segmentectomy or combined segmentectomy after intraoperative frozen-section confirmation of node-negative (N0) lymph node status. The primary endpoint is 3-year recurrence-free survival (RFS).

Key Dates

First listed
Aug 21, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2032
Completion
Aug 31, 2034

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: septum-guided segmentectomy
    Participants with 2-3 cm clinical stage IA3 peripheral non-small cell lung cancer and consolidation-to-tumor ratio (CTR) \>0.5 to \<=1.0 will undergo planned septum-guided anatomical segmentectomy or combined segmentectomy after intraoperative frozen-section confirmation of node-negative (N0) lymph node status.

Primary Outcome Measure

3-Year Recurrence-Free Survival [ Time Frame: Up to 3 years after surgery ]

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