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

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.

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

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