Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
invasive lung adenocarcinoma; systematically mediastinal lymph node dissection; ground-glass nodule
Brief summary
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
Detailed description
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%.
Interventions
PROCEDURENo mediastinal lymph node dissection
No mediastinal lymph node dissection will be performed.
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Treatment groups will be open to both patients and surgeons.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Clinical stage T1N0M0 and planned curative surgery. * A single lesion detected on computed tomography (CT) scan featured as ground glass nodule(GGO) and C/T ratio ≤0.5. * Age 18 to 75. * Patients who have signed the informed consent form.
Exclusion criteria
* Other than invasive adenocarcinoma by pathological analysis. * Patients undergoing wedge resection but not meeting the specific conditions of a Consolidation/Tumor Ratio (CTR) ≤ 0.25 AND a maximum tumor diameter ≤ 2 cm, based on the oncological outcomes of the JCOG0804/WJOG4507L trial. * Not complete resected or curative intent. * Patients who have history of other malignant tumors. * Patients who have history of thoracic surgery. * Patients who have received radiation, chemotherapy or other treatments previously.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 3 years after the surgery | Disease-free survival means the period after surgery when no disease can be detected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3 years after the surgery | Overall survival means the period after surgery when a patient doesn't die directly from lung cancer or an unrelated cause. |
| Rate of patients with perioperative complications | 1 month after the surgery | The perioperative complication includes death, wound infection, hemorrhage, infection, pleural effusion, pneumothorax, cardiovascular problem and etc. |
Countries
China
Contacts
Primary ContactHaoxuan Wu, Dr.
Backup ContactHaiquan Chen, Ph.D
Outcome results
None listed