Comparison of Different Types of Surgery in Treating Patients With Early-stage Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare early-stage peripheral non-small cell lung cancer lobectomy and sub-lobectomy surgery to evaluate if sub-lobectomy is as feasible and effective for the treatment of early-stage (diameter ≤2cm) peripheral non-small cell lung cancer as lobectomy.

Detailed Description
-----------------
Objectives:To establish a database of patients with early lung cancer surgery,and evaluate if sub-lobectomy surgery is as feasible and effective as lobectomy surgery in patients with early-stage peripheral non-small cell lung cancer,by assessing the retainability of lung function.and improvement of quality of life in those patients. Outline:This is a prospective, matched, controlled, open, multi-center clinical study. Select the early-stage peripheral NSCLC 630 patients (diameter≤2cm), according to age and lesion type (GGO component ratio) two matching factor of 1: 2 assigned to sub-lobectomy group and lobectomy group.Patients are followed up every 3 months for the first year and then every 6 months for the other 4 years.

Conditions
-----------------
Stage IA Non-small Cell Lung Cancer, Adenocarcinoma of the Lung, Squamous Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically diagnosed with stage I peripheral non-small cell lung cancer suitable for lobectomy. T≤2cm，N0，M0. aged 60 to 80 years old. ECOG≤2. according to the Ministry of Health, with primary lung cancer diagnostic and treatment practices (2011 edition) completed preoperative clinical staging examination. voluntary participation, signed informed consent. Exclusion Criteria: pathologic stage is N1, N2, or M1a. received postoperative adjuvant therapy (chemotherapy or targeted therapy). radiotherapy or chemotherapy before surgery. small cell lung cancer benign lesions patient unwilling to cooperate with surgery or observation.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm I<br>Patients undergo lobectomy | |
| Arm II<br>Patients undergo a wedge resection or anatomical segmentectomy | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | participants will be followed from surgical treatment at least 5 years unless any evidence of disease progression or death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | at least 5 years | 
| Pulmonary function |  | Forced expiratory volume in one second, FEV1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Carcinoma, Bronchogenic, Bronchial Neoplasms