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

Not Applicable

Recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT04527419
• Lead Sponsor: Fudan University

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%.

Study Timeline

• Study First Submitted: 2020-08-23
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-26
• Study Start: 2022-02-09
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-20
• Last Update Posted: 2025-08-26
• Primary Completion: 2026-07-21
• Study Completion: 2027-02-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 545

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Disease-free survival	3 years after the surgery	Disease-free survival means the period after surgery when no disease can be detected.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China