SLND or Not in cT1 GGO Invasive Lung Adenocarcinoma (ECTOP-1009)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No mediastinal lymph node dissection.
- Who it may be relevant to
- Registry conditions: Carcinoma, Non-Small-Cell Lung. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Systematically Mediastinal Lymph Node Dissection or Not in Stage T1 Ground-glass Dominated Invasive Lung Adenocarcinoma: a Multi-center, Prospective Clinical Trial
Overview
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
- Procedure No mediastinal lymph node dissection
No mediastinal lymph node dissection will be performed.
Primary outcome measures
- Disease-free survival [Time frame: 3 years after the surgery]
Secondary outcome measures (2)
- Overall survival [Time frame: 3 years after the surgery]
- Rate of patients with perioperative complications [Time frame: 1 month after the surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Publications
- Zhang Y, Qian B, Song Q, Ma J, Cao H, Deng C, Wang S, Ye T, Xiang J, Zhang Y, Sun Y, Yan Y, Zheng S, Wu H, Huang Q, Hu H, Li Y, Fu F, Chen H. Phase III Study of Mediastinal Lymph Node Dissection for Ground Glass Opacity-Dominant Lung Adenocarcinoma. J Clin Oncol. 2025 Oct;43(28):3081-3089. doi: 10.1200/JCO-25-00610. Epub 2025 Jul 21. PMID 40690727
Identifiers
NCT: NCT04527419 · SLNDILA