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
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Ethics review board of Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
Contact Information
Primary
Zhenfa Zhang, MD
zhangzhenfa1973@163.com
+862223340123
Backup
Chenguang Li, MD
cgli82@yeah.net
+862218622819082
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2029-05-01
Participants
Target number of participants: 1362
Treatments
Experimental: Mediastinal lymph node dissection group
A
Active_comparator: Spared mediastinal lymph node dissection group
B
Sponsors
Leads: Tianjin Medical University Cancer Institute and Hospital

This content was sourced from clinicaltrials.gov