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
Tianjin Medical University Cancer Institute and Hospital
1,362 participants
May 1, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria5
- 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.
Interventions
Systematic hilar and mediastinal lymph node dissection.
Mediastinal lymph node is spared in this group.
Locations(1)
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NCT04631770