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

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: Lung Neoplasms; Lymph Node Excision
• Intervention / Treatment: Procedure: Systemic mediastinal lymph node dissection; Procedure: Spared mediastinal lymph node dissection

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

• Study Contact: Name: Zhenfa Zhang, MD; Phone Number: +862223340123; Email: zhangzhenfa1973@163.com
• 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: Chenguang Li; Phone Number: +86-22-23340123; Email: chengdongyan916@163.com
      • Principal Investigator: Zhenfa Zhang, MD

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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

Collaborators and Investigators

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

Study record dates

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: Non-small cell lung cancer; Mediastinal lymph node dissection; Ground-glass nodules
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• 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