This is a study from Eastern Cooperative Thoracic Oncology Project, numbered as ECTOP-1009. Systematically mediastinal lymph node dissection or not in clinical stage T1 ground-glass dominated invasive lung adenocarcinoma: a multi-center, prospective clinical trial
Following interim analysis of 302 patients revealed no lymph node metastasis in either study arm and 100% 2-year disease-free survival in both arms. The selective non-mediastinal lymph node dissection (non-SLND) arm had reduced complications (JCO 2025; doi:10.1200/JCO-25-00610). The study design has been amended to a single-arm prospective cohort. All enrolled patients meeting inclusion criteria will sign informed consent and receive non-SLND. The primary endpoint remains 3-year disease-free survival (DFS). The sample size has been recalibrated to 545 patients based on historical control 3-year DFS of 96.6%, a stricter non-inferiority margin of 2.5%, 90% power, and the 1-sided alpha of 2.5%.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
545
No mediastinal lymph node dissection will be performed.
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGDisease-free survival
Disease-free survival means the period after surgery when no disease can be detected.
Time frame: 3 years after the surgery
Overall survival
Overall survival means the period after surgery when a patient doesn't die directly from lung cancer or an unrelated cause.
Time frame: 3 years after the surgery
Rate of patients with perioperative complications
The perioperative complication includes death, wound infection, hemorrhage, infection, pleural effusion, pneumothorax, cardiovascular problem and etc.
Time frame: 1 month after the surgery
Haiquan Chen, Ph.D
CONTACT
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