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

Systematically Mediastinal Lymph Node Dissection or Not in Stage T1 Ground-glass Dominated Invasive Lung Adenocarcinoma: a Multi-center, Prospective Clinical Trial

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

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Procedure: No mediastinal lymph node dissection

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 Type: Interventional
• Enrollment (Estimated): 545
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haoxuan Wu, Dr.; Phone Number: 86-13901770461; Email: haoxuanwu@hotmail.com
• Study Contact Backup: Name: Haiquan Chen, Ph.D

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: Haoxuan Wu, Doctor; Phone Number: (86)13901770461; Email: haoxuanwu@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: No mediastinal lymph node dissection group; Mediastinal lymph node dissection will not be performed.	Procedure: No mediastinal lymph node dissection; No mediastinal lymph node dissection will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	Disease-free survival means the period after surgery when no disease can be detected.	3 years after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival means the period after surgery when a patient doesn't die directly from lung cancer or an unrelated cause.	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.	1 month after the surgery

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Haiquan Chen, Ph.D, Shanghai Cancer center

Publications and helpful links

General 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 Jul 21:JCO2500610. doi: 10.1200/JCO-25-00610. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2022
• Primary Completion (Estimated): July 21, 2026
• Study Completion (Estimated): February 9, 2027

Study Registration Dates

• First Submitted: August 23, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: invasive lung adenocarcinoma; systematically mediastinal lymph node dissection; ground-glass nodule
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: SLNDILA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study Protocol, Inform Consent Form, Clinical Study Report would not be shared after the study begin.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No