Comparison of Sublobar and Lobectomy in Small (2 Cm or Less 0.5<CTR<1) Non-small Cell Lung Cancer: a Prospective, Multicenter Randomized Controlled Study
Sublobar: The minimize unit is the subsegment, the subloar group includes wedge resection, subsegmentectomy, segmentectomy.
It is recommended to perform intraoperative lymph node pathology (not mandatory). If lymph node metastasis is positive, we must switch to lobectomy+system lymph node dissection. lymph node sampling, selective lymph node dissection or systematic lymph node dissection are allowed in this group.
Lobectomy: lobectomy+system lymph node dissection
Study summary
The early NSCLC(Non-small cell lung cancer) patients with partial solid nodules mainly composed of solid components, whose maximum tumor diameter was ≤ 2.0cm and 0.5\<CTR(Consolidation tumor ratio)\<1, as indicated by preoperative thin slice CT, were selected as the study objects. The short-term and long-term effects of segmental resection and lobectomy under Thoracoscopy were compared to provide high-level evidence for the selection of surgical treatment methods for early NSCLC.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* nitial inclusion criteria:
1. Age 18-75 years old, regardless of gender;
2. ECOG PS score 0-1 points (Attachment 3.4);
3. Preoperative clinical staging for patients with suspected NSCLC lesions in Phase I (according to AJCC Eighth Edition staging standards, Attachment 3.5);
4. Thin slice CT indicates that the maximum tumor diameter is ≤ 2.0cm;
5. Pre operative CT prompts 0.5\<CTR\<1.0;
6. Good lung function (FEV1\>1.5 L or FEV1% ≥ 60%), able to tolerate both segmental resection and lobectomy;
7. The number of pulmonary nodules that need to be processed is ≤ 3, and the nodules are located in the same side of the lung;
8. Those who voluntarily sign the research informed consent form can comply with the research visit plan and other protocol requirements.
Exclusion Criteria:
Initial exclusion criteria:
1. Hypertension and diabetes difficult to control;
2. Pregnant or lactating women;
3. Those who have received anti-tumor treatment (radiotherapy, chemotherapy, Targeted therapy, immunotherapy) before surgery;
4. Previous history of lung surgery;
5. Interstitial pneumonia, Pulmonary fibrosis or severe Emphysema;
6. Those who undergo thoracotomy or change the surgical plan due to various reasons during surgery;
7. Severe mental illness;
8. Individuals with a history of severe heart disease, heart failure, myocardial infarction, or angina within the past 6 months;
9. Active bacterial or fungal infections that are difficult to control;
10. Individuals who have conducted other clinical trials in the three months prior to enrollment.
Secondary exclusion criteria:
1. The postoperative pathological result was Benign tumor;
2. Postoperative pathological results of non NSCLC malignant tumors;
3. Non small cell lung cancer confirmed histologically during operation, but with malignant Pleural effusion and pleural dissemination
Primary outcome measure(s)
DFS(Disease-free survival) — Follow up for 5 years for all patients after enrollment Disease-free survival (DFS) is a number that tells the chances of staying free of a disease or cancer after a particular treatment. It is the percentage of individuals in the treatment group who are likely to be free of the signs and symptoms of a disease after a specified duration of time.
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital of Air Force Medical University University of PLA
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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