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

Study Overview
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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

Detailed Description
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Patients will be evaluated for inclusion criteria and exclusion criteria, and then they will sign informal consent if desired. He/she will be randomly assigned to the intervention according to a prepared random tables. Patients in the systematically mediastinal lymph node dissection (SLND) group will receive systematically mediastinal lymph node dissection, while those in the non-SLND group will not receive mediastinal lymph node dissection. The primary endpoint is 3-year disease-free survival (DFS). The sample size was estimated with reference to our previous data, in which the 3-year DFS was 96.6% for patients diagnosed with cT1 ground glass opacity (GGO) dominated invasive lung adenocarcinoma and underwent SLND. We assumed that if 3-year DFS of patients in non-SLND group was over 91.6% , then we would deem the non-SLND group to be non-inferior to the SLND group. The sample size was estimated to be 638. In order to render the number of recruited patients for each tumor location conform to the actual distribution, we designed a random table for each tumor location. In our previous study, for cT1 GGO dominated invasion lung adenocarcinoma, tumor in the left upper lobe, left lower lobe, right upper lobe, right middle lobe and right lower lobe accounted for 24.7%, 13.2%, 37.6%, 6.6% and 17.9%, respectively. Therefore, the random number table for left upper lobe, left lower lobe, right upper lobe, right middle lobe and right lower lobe included 158 patients, 84 patients, 240 patients, 42 patients and 114 patients, respectively. The total number of patients enrolled was designed to be 638.

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

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Procedure: Systematically mediastinal lymph node dissection
* Procedure: No mediastinal lymph node dissection


Participation Criteria
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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. Other than lobectomy or sublobar resection in surgical procedure. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Random tables have been respectively developed according to tumor locaiton, which includes right-upper lobe, right-middle lobe, right-lower lobe, left-upper lobe and left-lower lobe. Prior to surgery, patients enrolled in the study will be assigned to treatment groups according to the order of the random tables.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Systematically mediastinal lymph node dissection group<br>Systematically mediastinal lymph node dissection will be performed. | Procedure: Systematically mediastinal lymph node dissection<br>* Systematically mediastinal lymph node dissection will be performed.<br>|
| Experimental: No mediastinal lymph node dissection group<br>Mediastinal lymph node dissection will not be performed. | Procedure: No mediastinal lymph node dissection<br>* No mediastinal lymph node dissection will be performed.<br>|

What is the study measuring?
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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 | 
| Distribution of lymph node metastasis | The distribution of lymph node metastasis refers to the number of metastatic lymph nodes per station and the proportion of metastatic lymph nodes to harvested lymph nodes. | 1 month after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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invasive lung adenocarcinoma; systematically mediastinal lymph node dissection; ground-glass nodule