Clinical trial NCT02288026: Comparison of Different Types of Surgery in Treating Patients With Early-stage Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stage IA Non-small Cell Lung Cancer
Adenocarcinoma of the Lung
Squamous Cell Lung Cancer
Keywords: Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Chao Yang Hospital
name: Beijing Friendship Hospital
name: Beijing Chest Hospital
name: Beijing Tongren Hospital
name: Peking University First Hospital
name: China-Japan Friendship Hospital
name: Peking Union Medical College Hospital
name: Chinese PLA General Hospital
name: Beijing Anzhen Hospital
name: Peking University Cancer Hospital & Institute
First posted: 2014-11-11
Enrollment: 630
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are stratified according to age and lesion type (GGO component ratio) two matching factor of 1: 2 to the lobectomy and sub-lobectomy surgery groups.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease-free survival
timeFrame: participants will be followed from surgical treatment at least 5 years unless any evidence of disease progression or death
Secondary outcomes:
measure: Overall survival
timeFrame: at least 5 years
measure: Pulmonary function
timeFrame: Forced expiratory volume in one second, FEV1
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu hospital capital medical university
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Xiuyi Zhi
role: PRINCIPAL_INVESTIGATOR
References: