RecruitingNot ApplicableNCT04944563

Comparison of Segmentectomy Versus Lobectomy for Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field

Comparison of Segmentectomy Versus Lobectomy for Early-stage Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field: A Prospective and Multi-center RCT Study

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

1,120 participants

Start Date

Jul 20, 2021

Study Type

INTERVENTIONAL

Conditions

Surgery Lung Neoplasms

Summary

This study aims to investigate whether segmentectomy had non-inferiority long-term oncological effects (disease-free survival and overall survival) compared with lobectomy in the treatment of patients with early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria11

Patient aged 18-75 years old;
mm ≤ tumor size ≤ 20 mm;
\< CTR \< 1;
Center of tumor located in the middle third of the lung field;
ECOG score of 0,1 or 2;
Lung function (FEV1 ≥ 1 L and ≥ 70%);
Both lung segmentectomy and lobectomy could achieve R0 resection;
No serious cardiopulmonary complications, and could withstand both lung segmentectomy and lobectomy;
No hilus pulmonis and mediastinal lymph node metastasis and no distant metastasis;
Single tumor nodule or the concomitant nodule \< microinvasive tumor;
Written informed consent.

Exclusion Criteria10

The tumor nodule is located in right middle lobe;
A history of other malignancies in the last 5 years (exclusion of early-staged thyroid cancer);
Have received preoperative anti-tumor therapy, including prior chemotherapy, radiation therapy, target therapy and so on;
A serious mental illness;
Pregnant and lactating women;
Congestive heart failure, myocardial infarction, severe stenosis of coronary artery within recent 6 months;
With the history of cerebral infarction or cerebral hemorrhage within 6 months;
With the history of sustained systemic corticosteroid therapy within 1 month;
The predicted surgical margin is less than 2 cm or the maximum diameter of the tumor at the 3D-CTBA
Other unsuitable situations;