Mediastinal Lymph Node Dissection Versus Spared Mediastinal Lymph Node Dissection in Stage I GGN NSCLC

September 24, 2023 updated by: Tianjin Medical University Cancer Institute and Hospital

Mediastinal Lymph Node Dissection Versus Spared Mediastinal Lymph Node Dissection in Stage IA Non-small Cell Lung Cancer Presented as Ground-glass Nodules: Study Protocol of a Phase III, Randomized, Multi-center Trial (MELDSIG) in China

Lung cancer is the leading cause of cancer related death worldwide. Lobectomy or sub-lobectomy with mediastinal lymph node dissection is the standard surgery. About 50% lung nodules are pure ground-glass or part-solid nodules. Non-solid nodules rarely develop mediastinal lymph node metastasis. The present study is a prospective, multicenter and randomized clinical trial, comparing the overall survival and disease-free survival of whether performing mediastinal lymph node dissection in non-small cell lung cancer with ground-glass nodule CT features.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is a non-inferior statistical comparison, with 681 patients in each group. The anticipated enroll period is 3 years, followed by observation period of 5 years.

Study Type

Interventional

Enrollment (Estimated)

1362

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

  • Name: Chenguang Li, MD
  • Phone Number: +862218622819082
  • Email: cgli82@yeah.net

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Ethics review board of Tianjin Medical University Cancer Institute and Hospital
        • Sub-Investigator:
          • Chenguang Li, MD
        • Contact:
        • Principal Investigator:
          • Zhenfa Zhang, MD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Thin-slice HRCT shows single GGN with C/T ≤ 0.5 and no lymph node metastasis;
  • Clinical stage IA NSCLC (TNM 8th classification) diagnosed prior or in surgery;
  • No history of malignancies within past 5 years or lung surgery;
  • No anti-cancer treatment prior to surgery.

Exclusion Criteria:

  • Simultaneous or metachronous (within the past 5 years) double cancers;
  • Active bacterial or fungous infection;
  • Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema;
  • Systemic steroidal medication;
  • Uncontrollable diabetes mellitus; (vi) Uncontrollable hypertension or history of severe heart disease, heart failure.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mediastinal lymph node dissection group
A
Procedure: Systemic mediastinal lymph node dissection
Systematic hilar and mediastinal lymph node dissection.
Active Comparator: Spared mediastinal lymph node dissection group
B
Procedure: Spared mediastinal lymph node dissection
Mediastinal lymph node is spared in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
Overall survival is defined as days from randomization to death from any cause, and it was censored at the last day when the patient was alive.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse-free survival
Time Frame: 5 years
RFS time is defined as days from randomization to relapse or death for any patient.
5 years
Proportion of local recurrence
Time Frame: 5 years
Proportion of local recurrence in any kind of recurrences.
5 years
Duration of hospitalization
Time Frame: 1-60 days
Duration of hospitalization around surgery.
1-60 days
Duration of chest drainage tube placement
Time Frame: 1-60 days
Duration of chest drainage tube placement after surgery.
1-60 days
Operation time
Time Frame: 20-180 minutes.
Time duration of surgery.
20-180 minutes.
Blood loss
Time Frame: 1-60 days
Blood loss during surgery.
1-60 days

Collaborators and Investigators

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

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Investigators

  • Principal Investigator: Zhenfa Zhenfa, MD, Tianjin Medical University Cancer Institute and Hospital

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)

May 1, 2022

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

November 15, 2020

First Submitted That Met QC Criteria

November 15, 2020

First Posted (Actual)

November 17, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2020306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data will be available after publication of the study.

IPD Sharing Time Frame

After the follow-up period of the study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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