Menu
Recruiting NCT04631770

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

No phase Interventional Lung Neoplasms Lymph Node Excision

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Systemic mediastinal lymph node dissection, Spared mediastinal lymph node dissection.
Who it may be relevant to
Registry conditions: Lung Neoplasms, Lymph Node Excision. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Procedure Systemic mediastinal lymph node dissection
    Systematic hilar and mediastinal lymph node dissection.
  • Procedure Spared mediastinal lymph node dissection
    Mediastinal lymph node is spared in this group.

Primary outcome measures

  • Overall survival [Time frame: 5 years]
Secondary outcome measures (6)
  • Relapse-free survival [Time frame: 5 years]
  • Proportion of local recurrence [Time frame: 5 years]
  • Duration of hospitalization [Time frame: 1-60 days]
  • Duration of chest drainage tube placement [Time frame: 1-60 days]
  • Operation time [Time frame: 20-180 minutes.]
  • Blood loss [Time frame: 1-60 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Ethics review board of Tianjin Medical University Cancer Institute and Hospital — Tianjin

Publications

  • 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

Identifiers

NCT: NCT04631770 · E2020306

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗