Comparison of Segmentectomy Versus Lobectomy for Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field

April 2, 2022 updated by: The First Affiliated Hospital with Nanjing Medical University

Comparison of Segmentectomy Versus Lobectomy for Early-stage Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field: A Prospective and Multi-center RCT Study

This study aims to investigate whether segmentectomy had non-inferiority long-term oncological effects (disease-free survival and overall survival) compared with lobectomy in the treatment of patients with early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Nowadays, the role of segment resection in the treatment of non-small cell lung cancer ≤ 2 cm in the outer third of the lung field has been evaluated in multiple studies. Recently, professor Hisao Asamura released the long-term results of the JCOG0802 project in AATS 2021. Segmentectomy had a higher 5-year overall survival (94.3% vs. 91.1%) than lobectomy (P < 0.001) for non-small cell lung cancer ≤ 2 cm (CTR > 0.5) in the outer third of the lung field. However, a substantial portion of lung nodules was not located in the outer third, but the middle third of the lung field. Whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field remains unclear. This randomized controlled trial study aims to investigate whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of the lung field.

Study Type

Interventional

Enrollment (Anticipated)

1120

Phase

  • Not Applicable

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

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital, the First Affiliated Hospital of Nanjing Medical University
        • Contact:
        • Principal Investigator:
          • Liang Chen, M.D.
        • Sub-Investigator:
          • Weibing Wu, M.D.

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient aged 18-75 years old;
  2. 6 mm ≤ tumor size ≤ 20 mm;
  3. 0.25 < CTR < 1;
  4. Center of tumor located in the middle third of the lung field;
  5. ECOG score of 0,1 or 2;
  6. Lung function (FEV1 ≥ 1 L and ≥ 70%);
  7. Both lung segmentectomy and lobectomy could achieve R0 resection;
  8. No serious cardiopulmonary complications, and could withstand both lung segmentectomy and lobectomy;
  9. No hilus pulmonis and mediastinal lymph node metastasis and no distant metastasis;
  10. Single tumor nodule or the concomitant nodule < microinvasive tumor;
  11. Written informed consent.

Exclusion Criteria:

  1. The tumor nodule is located in right middle lobe;
  2. A history of other malignancies in the last 5 years (exclusion of early-staged thyroid cancer);
  3. Have received preoperative anti-tumor therapy, including prior chemotherapy, radiation therapy, target therapy and so on;
  4. A serious mental illness;
  5. Pregnant and lactating women;
  6. Congestive heart failure, myocardial infarction, severe stenosis of coronary artery within recent 6 months;
  7. With the history of cerebral infarction or cerebral hemorrhage within 6 months;
  8. With the history of sustained systemic corticosteroid therapy within 1 month;
  9. The predicted surgical margin is less than 2 cm or the maximum diameter of the tumor at the 3D-CTBA
  10. Other unsuitable situations;

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Segmentectomy
Patients receive segmentectomy
Procedure: Segmentectomy
Patients receive segmentectomy
Active Comparator: Lobectomy
Patients receive lobectomy
Procedure: Lobectomy
Patients receive lobectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year Disease-Free Survival
Time Frame: From date of the recruitment, assessed up to 60 months
The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality
From date of the recruitment, assessed up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day Morbidity and mortality rates
Time Frame: From date of the recruitment, assessed up to 30 days
The rates of complications and death related to treatment during perioperative period
From date of the recruitment, assessed up to 30 days
Pulmonary function in the first year after surgery
Time Frame: From date of the 3rd, 6th, and 12th month after surgery
The Forced expiratory volume in one second (FEV1) in liter
From date of the 3rd, 6th, and 12th month after surgery
3-year Disease-Free-Survival
Time Frame: From date of the recruitment, assessed up to 36 months
The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality
From date of the recruitment, assessed up to 36 months
5-year overall Survival
Time Frame: From date of the recruitment, assessed up to 60 months
The time interval from randomization to death caused by any reason
From date of the recruitment, assessed up to 60 months

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: Liang Chen, M.D., The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 20, 2021

Primary Completion (Anticipated)

December 1, 2029

Study Completion (Anticipated)

December 1, 2029

Study Registration Dates

First Submitted

June 17, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 2, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-SR-164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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