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

NCT04631770 · tracked via the Priya Life Science China tracker

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Phase

Not applicable

Started

2022-05-01

Last updated

2023-09-28

Condition(s) studied

Lung NeoplasmsLymph Node Excision

Investigational drug(s) / intervention(s)

Systemic mediastinal lymph node dissectionSpared mediastinal lymph node dissection

Systemic mediastinal lymph node dissection: Systematic hilar and mediastinal lymph node dissection.

Spared mediastinal lymph node dissection: Mediastinal lymph node is spared in this group.

Study 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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Overall survival — 5 years
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.

Trial sites (1)

Facility	City	Region	Status
Ethics review board of Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin Municipality	Recruiting

More Tianjin Medical University Cancer Institute and Hospital trials in China

Albumin-bound Paclitaxel Combined With Gemcitabine First-line Inoperable Pancreatic Cancer Recruiting

Efficacy and Safety of HAIC Combined With Lenvatinib and PD-1 Inhibitors for Advanced Intrahepatic Cholangiocarcinoma Active, not recruiting

Prognostic Model of Elderly Hodgkin Lymphoma in China Active, not recruiting

TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors Recruiting

QL1706 Plus Chidamide, AG as First-line Treatment for Metastatic Pancreatic Cancer Recruiting

Other trials for the same condition

Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection for Treatment of Multiple Ground-Glass Lung Nodules: A Single-Arm Clinical Study Starting soon

Effect of Modified Arm Positioning on Shoulder Pain After Thoracoscopic Lobectomy Recruiting

Post-line Treatment With Teniposide for c-Myc-driven Extensive-stage Small Cell Lung Cancer Recruiting

Vebreltinib Plus Chemotherapy as First-line Treatment for MET-overexpressing NSCLC Starting soon

Osimertinib With Chemotherapy as First-line Therapy for EGFR Mutation-positive NSCLC Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04631770 on ClinicalTrials.gov ↗ ← All trials in China