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

NCT ID: NCT02288026

Last Updated: 2014-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

630 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Arm I

Patients undergo lobectomy

No interventions assigned to this group

Arm II

Patients undergo a wedge resection or anatomical segmentectomy

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

Beijing Chest Hospital

OTHER

Sponsor Role collaborator

Beijing Tongren Hospital

OTHER

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xiuyi zhi

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiuyi Zhi

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

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Xuanwu hospital capital medical university

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiuyi Zhi

Role: CONTACT

+86 10 83198287

Mu Hu

Role: CONTACT

+86 10 83198646

Facility Contacts

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Xiuyi Zhi

Role: primary

+86 10 83198287

Other Identifiers

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D14110700020000

Identifier Type: -

Identifier Source: org_study_id