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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04631770
• Other study ID #: E2020306
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: May 1, 2029

Study information

• Verified date: May 2023
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Zhenfa Zhang, MD
• Phone: +862223340123
• Email: zhangzhenfa1973[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1362
• Est. completion date: May 1, 2029
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Lymph Node Excision

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Ethics review board of Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	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.	5 years
Secondary	Relapse-free survival	RFS time is defined as days from randomization to relapse or death for any patient.	5 years
Secondary	Proportion of local recurrence	Proportion of local recurrence in any kind of recurrences.	5 years
Secondary	Duration of hospitalization	Duration of hospitalization around surgery.	1-60 days
Secondary	Duration of chest drainage tube placement	Duration of chest drainage tube placement after surgery.	1-60 days
Secondary	Operation time	Time duration of surgery.	20-180 minutes.
Secondary	Blood loss	Blood loss during surgery.	1-60 days