Chest Lymph Node Sampling in Patients With Advanced Lung Cancer to be Treated With Curative-intent Radiation Treatment

Study Overview
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Brief Summary
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This study will investigate the role of sampling suspicious chest lymph nodes with a procedure called endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA) or transesophageal ultrasound-guided fine needle aspiration (EUS-FNA) in patients planned to receive radical dose radiation. This study will use Stereotactic Ablative Radiotherapy (SABR) for treatment methods. SABR is a newer radiation treatment that delivers high-dose, precise radiation to small tumors and can be delivered more accurately than with older radiation treatment methods. It is considered a standard treatment for small lung cancers, and select cancers that have spread to the brain. The purpose of this study is to compare if the lymph node sampling procedure is valuable for determining the extend of nodal disease in metastatic Non-Small Cell Lung Cancer (NSCLC) compared to imaging alone.

Official Title
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Endoscopic Nodal Staging in Oligometastatic Non-small Cell Lung Cancer (NSCLC) Being Treated With Stereotactic Ablative Radiotherapy (ENDO-SABR)

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Procedure: Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA)
* Procedure: Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with oligometastatic non-small cell lung cancer (NSCLC), including a primary lung tumour (± hilar/mediastinal adenopathy) with up to 5 synchronous metastases Radical treatment intent to all sites is recommended at multi-disciplinary tumour board or by discussion by medical oncologist and radiation oncologist and/or surgeon. Age 18 years or older Good performance status (Eastern Cooperative Oncology Group [ECOG 0-1) with life-expectancy of at least 6 months as determined by enrolling physician Patient has undergone staging investigations less than 3 months prior to registration. Positron Emission Tomography (PET) / Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) brain (CT brain with contrast if contraindication to MRI) OR CT chest/abdomen, radionucleotide bone scan and MRI of brain (CT brain with contrast if contraindication to MRI) Pathologic confirmation of NSCLC Exclusion Criteria: Contraindication to Endobronchial Ultrasound (EBUS) / Endoscopic Ultrasound (EUS) Unable to provide consent for EBUS/EUS Contraindication to chest radiotherapy Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 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: Treatment Arm<br>Small pieces of suspicious chest lymph nodes will be removed with a procedure called endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA) or transesophageal ultrasound-guided fine needle aspiration (EUS-FNA). | Procedure: Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA)<br>* Chest lymph node sampling procedure by EBUS<br>Procedure: Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA)<br>* Chest lymph node sampling procedure by EUS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes to treatment intent and/or plan | Number of patients whose treatment is changed from stereotactic ablative radiotherapy (SABR) to conventional dose radiation, change in mediastinal radiation field, change from curative intent to palliative intent treatment | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the proportion of patients with occult mediastinal metastasis | Pre-staging treatment planning anticipated lymph nodes to be treated compared to post staging lymph nodes to be treated | 2 years | 
| Determine the sensitivity and specificity of radiologic staging of hilar/mediastinal lymph nodes | Nodal staging on imaging alone versus nodal staging after sampling | 2 years | 
| Identify the total number of lymph nodes sampled per procedure | Record the total number of lymph nodes sampled | 2 years | 
| Identify the nodal stations sampled | Record the nodal stations that were sampled | 2 years | 
| Determine the proportion of patients with complications of endoscopic procedure | Number of participants with complications versus number without | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oligometastatic Non-Small Cell Lung Cancer, Stereotactic Ablative Radiotherapy