About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Systemic mediastinal lymph node dissection
Procedure/SurgerySystematic hilar and mediastinal lymph node dissection.
Spared mediastinal lymph node dissection
Procedure/SurgeryMediastinal lymph node is spared in this group.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Relapse-free survival
RFS time is defined as days from randomization to relapse or death for any patient.
Proportion of local recurrence
Proportion of local recurrence in any kind of recurrences.
Duration of hospitalization
Duration of hospitalization around surgery.
Duration of chest drainage tube placement
Duration of chest drainage tube placement after surgery.
Sponsors and contacts
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