Brief Title
Comparison of Different Types of Surgery in Treating Patients With Early-stage Non-small Cell Lung Cancer
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.
Study Type
Observational
Primary Outcome
Disease-free survival
Secondary Outcome
Overall survival
Condition
Stage IA Non-small Cell Lung Cancer
Study Arms / Comparison Groups
Arm I
Description: Patients undergo lobectomy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
630
Start Date
September 2014
Primary Completion Date
December 2017
Eligibility 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.
Gender
All
Ages
60 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Xiuyi Zhi, +86 10 83198287,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02288026
Organization ID
D14110700020000
Responsible Party
Principal Investigator
Study Sponsor
Capital Medical University
Collaborators
Beijing Chao Yang Hospital
Study Sponsor
Xiuyi Zhi, Principal Investigator, Xuanwu Hospital, Beijing
Verification Date
November 2014