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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

545 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-09

Study Completion Date

2027-02-09

Brief Summary

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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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Detailed Description

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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%.

Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Treatment groups will be open to both patients and surgeons.

Study Groups

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No mediastinal lymph node dissection group

Mediastinal lymph node dissection will not be performed.

Group Type EXPERIMENTAL

No mediastinal lymph node dissection

Intervention Type PROCEDURE

No mediastinal lymph node dissection will be performed.

Interventions

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No mediastinal lymph node dissection

No mediastinal lymph node dissection will be performed.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No