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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
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.
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Ethics review board of Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Start Date
May 1, 2022
Primary Completion Date
May 1, 2024
Completion Date
May 1, 2029
Last Updated
September 28, 2023
1,362
ESTIMATED participants
Systemic mediastinal lymph node dissection
PROCEDURE
Spared mediastinal lymph node dissection
PROCEDURE
Lead Sponsor
Tianjin Medical University Cancer Institute and Hospital
NCT07143110
NCT06885697
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT04577599