Comparison of Different Types of Surgery in Treating Patients With Early-stage Non-small Cell Lung Cancer
Conditions
Stage IA Non-small Cell Lung Cancer - Adenocarcinoma of the Lung - Squamous Cell Lung Cancer
Conditions: official terms
Adenocarcinoma - Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Carcinoma, Bronchogenic, Bronchial Neoplasms
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 60 Years
Gender: Both
Criteria: Inclusion Criteria:

1. clinically diagnosed with stage I peripheral non-small cell lung cancer suitable for lobectomy.

2. T≤2cm,N0,M0.

3. aged 60 to 80 years old.

4. ECOG≤2.

5. according to the Ministry of Health, "with primary lung cancer diagnostic and treatment practices" (2011 edition) completed preoperative clinical staging examination.

6. voluntary participation, signed informed consent.

Exclusion Criteria:

1. pathologic stage is N1, N2, or M1a.

2. received postoperative adjuvant therapy (chemotherapy or targeted therapy).

3. radiotherapy or chemotherapy before surgery.

4. small cell lung cancer

5. benign lesions

6. patient unwilling to cooperate with surgery or observation.
Location
Xuanwu hospital capital medical university
Beijing, China
Status: Recruiting
Contact: Xiuyi Zhi - +86 10 83198287
Start Date
September 2014
Sponsors
Capital Medical University
Source
Capital Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page