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

August 20, 2025 updated by: Haiquan Chen, Fudan University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Haiquan Chen, Ph.D

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 3 years after the surgery
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
Time Frame: 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.
3 years after the surgery
Rate of patients with perioperative complications
Time Frame: 1 month after the surgery
The perioperative complication includes death, wound infection, hemorrhage, infection, pleural effusion, pneumothorax, cardiovascular problem and etc.
1 month after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Haiquan Chen, Ph.D, Shanghai Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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