NCT04631770

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,362 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

The study is a non-inferior statistical comparison, with 681 patients in each group. The anticipated enroll period is 3 years, followed by observation period of 5 years.

Conditions

• Lung Neoplasms
• Lymph Node Excision

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-05-01
• Completion: 2029-05-01
• First posted: 2020-11-17
• Last updated: 2023-09-28

Locations

1 site across 1 country: China