SLND or Not in cT1 GGO Invasive Lung Adenocarcinoma (ECTOP-1009)

Fudan University

Status: Enrolling

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Procedure: No mediastinal lymph node dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT04527419

SLNDILA

Details and patient eligibility

About

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

Full 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%.

Enrollment: 545 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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545 participants in 1 patient group

No mediastinal lymph node dissection group

Experimental group

Description:

Mediastinal lymph node dissection will not be performed.

Treatment:

Procedure: No mediastinal lymph node dissection