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

NCT04631770 | Recruiting

• 1 other identifier: E2020306
• Study Type: interventional
• Target: 1,362
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Neoplasms; Lymph Node Excision

Keywords

Non-small cell lung cancer; Mediastinal lymph node dissection; Ground-glass nodules

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Relapse-free survival

  5 years

• Proportion of local recurrence

  5 years

• Duration of hospitalization

  1-60 days

• Duration of chest drainage tube placement

  1-60 days

• Operation time

  20-180 minutes.

Study Arms (2)

Mediastinal lymph node dissection group

EXPERIMENTAL

A

Procedure: Systemic mediastinal lymph node dissection

Spared mediastinal lymph node dissection group

ACTIVE COMPARATOR

B

Procedure: Spared mediastinal lymph node dissection

Interventions

Systemic mediastinal lymph node dissection PROCEDURE

Systematic hilar and mediastinal lymph node dissection.

Mediastinal lymph node dissection group

Spared mediastinal lymph node dissection PROCEDURE

Mediastinal lymph node is spared in this group.

Spared mediastinal lymph node dissection group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Ethics review board of Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Related Publications (1)

• Li C, Ni Y, Liu C, Liu R, Zhang C, Song Z, Liu H, Jiang T, Zhang Z. 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, randomised, multicentre trial (MELDSIG) in China. BMJ Open. 2023 Oct 28;13(10):e075242. doi: 10.1136/bmjopen-2023-075242.

  PMID: 37898488 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Zhenfa Zhenfa, MD

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenfa Zhang, MD

CONTACT

+862223340123; zhangzhenfa1973@163.com

Chenguang Li, MD

CONTACT

+862218622819082; cgli82@yeah.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2020
• First Posted: November 17, 2020
• Study Start: May 1, 2022
• Primary Completion: May 1, 2024
• Study Completion (Estimated): May 1, 2029
• Last Updated: September 28, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After the follow-up period of the study.

Locations

CN (1)