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

Tianjin Medical University

Status

Enrolling

Conditions

Lung Neoplasms

Lymph Node Excision

Treatments

Procedure: Systemic mediastinal lymph node dissection

Procedure: Spared mediastinal lymph node dissection

Study type

Interventional

Funder types

Other

Identifiers

NCT04631770

E2020306

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,362 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.