The First Affiliated Hospital with Nanjing Medical University
Phase
Not applicable
Started
2021-07-20
Last updated
2022-04-05
Condition(s) studied
Lung NeoplasmsSurgery
Investigational drug(s) / intervention(s)
SegmentectomyLobectomy
Segmentectomy: Patients receive segmentectomy
Lobectomy: Patients receive lobectomy
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patient aged 18-75 years old;
2. 6 mm ≤ tumor size ≤ 20 mm;
3. 0.25 \< CTR \< 1;
4. Center of tumor located in the middle third of the lung field;
5. ECOG score of 0,1 or 2;
6. Lung function (FEV1 ≥ 1 L and ≥ 70%);
7. Both lung segmentectomy and lobectomy could achieve R0 resection;
8. No serious cardiopulmonary complications, and could withstand both lung segmentectomy and lobectomy;
9. No hilus pulmonis and mediastinal lymph node metastasis and no distant metastasis;
10. Single tumor nodule or the concomitant nodule \< microinvasive tumor;
11. Written informed consent.
Exclusion Criteria:
1. The tumor nodule is located in right middle lobe;
2. A history of other malignancies in the last 5 years (exclusion of early-staged thyroid cancer);
3. Have received preoperative anti-tumor therapy, including prior chemotherapy, radiation therapy, target therapy and so on;
4. A serious mental illness;
5. Pregnant and lactating women;
6. Congestive heart failure, myocardial infarction, severe stenosis of coronary artery within recent 6 months;
7. With the history of cerebral infarction or cerebral hemorrhage within 6 months;
8. With the history of sustained systemic corticosteroid therapy within 1 month;
9. The predicted surgical margin is less than 2 cm or the maximum diameter of the tumor at the 3D-CTBA
10. Other unsuitable situations;
Primary outcome measure(s)
5-year Disease-Free Survival — From date of the recruitment, assessed up to 60 months The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality
Trial sites (1)
Facility
City
Region
Status
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University
Nanjing
Jiangsu
Recruiting
More The First Affiliated Hospital with Nanjing Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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