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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02288026

Enrollment

630

Registered

2014-11-11

Start date

2014-09-30

Completion date

Unknown

Last updated

2014-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma of the Lung, Squamous Cell Lung Cancer, Stage IA Non-small Cell Lung Cancer

Keywords

Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Carcinoma, Bronchogenic, Bronchial Neoplasms

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

60 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Disease-free survival	participants will be followed from surgical treatment at least 5 years unless any evidence of disease progression or death

Secondary

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

Countries

China

Contacts

Primary ContactXiuyi Zhi

+86 10 83198287

Backup ContactMu Hu

+86 10 83198646

Outcome results