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

Capital Medical University

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT02288026

D14110700020000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 630 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No 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.

Trial design

630 participants in 2 patient groups

Arm I

Description:

Patients undergo lobectomy

Arm II

Description:

Patients undergo a wedge resection or anatomical segmentectomy