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

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · Nov 15, 2020

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical approaches for patients with a specific type of lung cancer called non-small cell lung cancer (NSCLC) that appears as a ground-glass nodule on a CT scan. The researchers want to find out if removing the lymph nodes in the chest (mediastinal lymph node dissection) helps patients live longer or stay cancer-free compared to not removing these lymph nodes during surgery. This is important because many of these nodules are less likely to spread to the lymph nodes, and the trial aims to see if the extra surgery is necessary.

To be eligible for this trial, participants must have a single ground-glass nodule with certain characteristics, and they should not have any previous lung surgeries or cancer treatments. Key health conditions, like severe heart disease or active infections, could prevent someone from joining. If a person qualifies and chooses to participate, they will undergo a surgery where their specific treatment will be determined based on which group they are assigned to in the study. Overall, this trial is looking to provide more clarity on the best surgical approach for patients with this type of lung cancer, potentially improving outcomes for future patients.

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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.