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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,362
- Locations
- 1
- Primary Endpoint
- Overall survival
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Mediastinal lymph node dissection group
A
Intervention: Systemic mediastinal lymph node dissection (Procedure)
Spared mediastinal lymph node dissection group
B
Intervention: Spared mediastinal lymph node dissection (Procedure)
Outcomes
Primary Outcomes
Overall survival
Time Frame: 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 Outcomes
- Relapse-free survival(5 years)
- Duration of hospitalization(1-60 days)
- Duration of chest drainage tube placement(1-60 days)
- Operation time(20-180 minutes.)
- Blood loss(1-60 days)
- Proportion of local recurrence(5 years)