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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02288026
Other study ID # D14110700020000
Secondary ID
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. completion date
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


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
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