Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (1)

Ethics review board of Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China