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

November 7, 2014 updated by: Xiuyi zhi, Capital Medical University
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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

630

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiuyi Zhi
  • Phone Number: +86 10 83198287

Study Contact Backup

  • Name: Mu Hu
  • Phone Number: +86 10 83198646

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Xuanwu Hospital Capital Medical University
        • Contact:
          • Xiuyi Zhi
          • Phone Number: +86 10 83198287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Arm I
Patients undergo lobectomy
Arm II
Patients undergo a wedge resection or anatomical segmentectomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Collaborators

Peking University First Hospital
Beijing Friendship Hospital
Peking Union Medical College Hospital
Chinese PLA General Hospital
Peking University Cancer Hospital & Institute
Beijing Tongren Hospital
Beijing Chao Yang Hospital
Beijing Chest Hospital
Beijing Anzhen Hospital
China-Japan Friendship Hospital

Investigators

  • Principal Investigator: Xiuyi Zhi, Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 11, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (Estimate)

November 11, 2014

Study Record Updates

Last Update Posted (Estimate)

November 11, 2014

Last Update Submitted That Met QC Criteria

November 7, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D14110700020000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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