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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lung Neoplasms, Lymph Node Excision

Intervention / Treatment
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* Procedure: Systemic mediastinal lymph node dissection
* Procedure: Spared mediastinal lymph node dissection


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small cell lung cancer, Mediastinal lymph node dissection, Ground-glass nodules