Segmentectomy vs Lobectomy for 2 - 3cm IASLC Grade 1-2 Lung Adenocarcinoma: A Multi-center RCT

NCT07169903 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 587

Last updated 2025-09-12

No results posted yet for this study

Summary

This study is a prospective, multicenter randomized controlled trial (RCT) designed to compare the efficacy of segmentectomy and lobectomy for invasive lung adenocarcinoma with a diameter of 2-3 cm and intraoperative frozen section-confirmed IASLC pathological new grade 1-2. The non-inferiority of segmentectomy is primarily evaluated by 5-year relapse-free survival (RFS) and overall survival (OS) after surgery, while secondary endpoints include pulmonary function preservation, perioperative complications, etc. With a planned enrollment of 587 patients over a 3-year recruitment period and a 5-year follow-up, this study aims to identify an optimized surgical approach.

Conditions

Interventions

PROCEDURE

Pulmonary segmentectomy

Segmentectomy is applied to lung adenocarcinomas with a diameter of 2-3 cm, in which intraoperative frozen pathology confirms a new pathological grade of 1-2.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER
  • Affiliated Hospital of Nantong University

    collaborator OTHER
  • Huadong Hospital

    collaborator OTHER
  • Anhui Chest Hospital

    collaborator OTHER
  • Ningbo No. 1 Hospital

    collaborator OTHER
  • Ningbo No.2 Hospital

    collaborator OTHER
  • Center hospital of Nanyang

    collaborator UNKNOWN
  • The Affiliated Hospital of Xuzhou Medical University

    collaborator OTHER
  • Huzhou Central Hospital

    collaborator OTHER
  • Anhui Provincial Hospital

    collaborator OTHER_GOV
  • Shandong Public Health Clinical Center

    collaborator OTHER_GOV
  • Shanghai Pulmonary Hospital, Shanghai, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2033-03-31
Completion
2033-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07169903 on ClinicalTrials.gov