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

• Conditions: Adenocarcinoma of the Lung; Stage IA Non-small Cell Lung Cancer; Squamous Cell Lung Cancer

• Registration Number: NCT02288026
• Lead Sponsor: Capital Medical University

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-11
• Status Verified: 2014-11
• Study First Submitted QC: 2014-11-07
• Last Update Submitted: 2014-11-07
• Study First Posted: 2014-11-11
• Last Update Posted: 2014-11-11
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 630

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Overall survival	at least 5 years
Pulmonary function	Forced expiratory volume in one second, FEV1

Trial Locations

Locations (1)

Xuanwu hospital capital medical university; 🇨🇳 Beijing, China