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NCT Number: NCT04527419

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

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

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No mediastinal lymph node dissection

Procedure

No mediastinal lymph node dissection will be performed.

Primary outcomes

  1. Disease-free survival

    Time frame: 3 years after the surgery

    Disease-free survival means the period after surgery when no disease can be detected.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haiquan Chen, Ph.D

CONTACT

Haoxuan Wu, Dr.

CONTACT

[email protected]

86-13901770461

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Aug 26, 2020
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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