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

Not Applicable

Recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Procedure: Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA); Procedure: Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA)

• Registration Number: NCT04852588
• Lead Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-21
• Study Start: 2021-11-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 29

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.

  1. Positron Emission Tomography (PET) / Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) brain (CT brain with contrast if contraindication to MRI) OR
  2. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA)	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).
Treatment Arm	Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA)	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).

Primary Outcome Measures

Name	Time	Method
Changes to treatment intent and/or plan	2 years	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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

London Health Sciences Centre - London Regional Cancer Program; 🇨🇦 London, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada