Comparison of Segmentectomy Versus Lobectomy for Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field
Recruiting · NCT04944563 · Interventional (participants receive a specific treatment) · Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
View the official record on ClinicalTrials.gov →Interventions studied
LobectomySegmentectomy
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patient aged 18-75 years old;
- 6 mm ≤ tumor size ≤ 20 mm;
- 0.25 \< 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 criteria
- 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;
Where it is running
1 location listed.
- Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University - Nanjing, Jiangsu, China