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

Not Applicable

Recruiting

• Conditions: Lung Neoplasms; Lymph Node Excision
• Interventions: Procedure: Systemic mediastinal lymph node dissection; Procedure: Spared mediastinal lymph node dissection

• Registration Number: NCT04631770
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-11-15
• Study First Submitted QC: 2020-11-15
• Study First Posted: 2020-11-17
• Study Start: 2022-05-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-09-24
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-05-01
• Study Completion: 2029-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1362

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mediastinal lymph node dissection group	Systemic mediastinal lymph node dissection	A
Spared mediastinal lymph node dissection group	Spared mediastinal lymph node dissection	B

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ethics review board of Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China