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

Squamous Cell Lung Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02288026
• Other study ID #: D14110700020000
• Status: Recruiting
• Phase: N/A
• First received: October 11, 2014
• Last updated: November 7, 2014
• Start date: September 2014

Study information

• Verified date: November 2014
• Source: Capital Medical University
• Contact: Xiuyi Zhi
• Phone: +86 10 83198287
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 630
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Lung
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Squamous Cell Lung Cancer
• Stage IA Non-small Cell Lung Cancer

Locations

Country	Name	City	State
China	Xuanwu hospital capital medical university	Beijing

Sponsors (11)

Lead Sponsor	Collaborator
Capital Medical University	Beijing Anzhen Hospital, Beijing Cancer Hospital, Beijing Chao Yang Hospital, Beijing Chest Hospital, Beijing Friendship Hospital, Beijing Tongren Hospital, China-Japan Friendship Hospital, Chinese PLA General Hospital, Peking Union Medical College Hospital, Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival		participants will be followed from surgical treatment at least 5 years unless any evidence of disease progression or death	No
Secondary	Overall survival		at least 5 years	No
Secondary	Pulmonary function		Forced expiratory volume in one second, FEV1	No