Selective Lymph Node Dissection for cT1N0M0 Invasive NSCLC With CTR>0.5 Located in the Apical Segment (ECTOP-1018)

Study Overview
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Brief Summary
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This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1018. The goal of this clinical trial is to confirm the theraputic effect of selective lymph node dissection for cT1N0M0 invasive non-small cell lung cancer with CTR>0.5 located in the apical segment. The main questions it aims to answer are: The 5-year overall survival of patients having cT1N0M0 invasive non-small cell lung cancer with CTR>0.5 located in the apical segment; The post-operative lymph node metastasis and recurrence-free survival. Participants will receive selective lymph node dissection as the surgical procedure.

Official Title
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Selective Lymph Node Dissection for cT1N0M0 Invasive Non-small Cell Lung Cancer With CTR>0.5 Located in the Apical Segment: a Single-arm, Multi-center, Phase III Trial

Conditions
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Lung Adenocarcinoma, Lymph Node Metastasis

Intervention / Treatment
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* Procedure: Selective Lymph Node Dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who sign the informed consent form and are willing to complete the study according to the plan; Aged from 18 to 80 years old; ECOG equals 0 or 1; Not receiving lung cancer surgery before; Resectable peripheral cT1N0M0 tumors with CTR>0.5 located in the apical segment; Non-lepidic predominant invasive NSCLC dignosed by frozen section; Not receiving chemotherapy or radiotherapy before. Exclusion Criteria: Not cT1N0M0; Nodules not located in the apical segment or CTR≤0.5; Pre-invasive lung adenocarcinoma, lepidic predominant adenocarcinoma, or not lung adenocarcinoma diagnosed cytologically or pathologically; Receiving lung cancer surgery before; Receiving radiotherapy or chemotherapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selective Lymph Node Dissection<br>Selective Lymph Node Dissection is performed for cT1N0M0 Invasive Non-small Cell Lung Cancer With CTR>0.5 Located in the Apical Segment | Procedure: Selective Lymph Node Dissection<br>* For patients with NSCLC with CTR>0.5 located in the apical segment, the inferior mediastinal lymph node was not need to dissected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year overall survival | The event is defined as the death due to any causes. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymph node metastasis | the lymph node metastasis situation of each pathological subtype | 5 years | 
| 5-year recurrence-free survival | The event is defined as the tumor recurrence. | 5 years | 
| The accuracy of frozen section | The concordance of frozen section and final pathological diagnosis for invasiveness | 5 years |