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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04852588
• Other study ID #: ENDO-SABR
• Secondary ID: ReDA #11162
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2021
• Est. completion date: May 31, 2025

Study information

• Verified date: February 2024
• Source: Lawson Health Research Institute
• Contact: Inderdeep Dhaliwal, MD
• Phone: 519-685-8500
• Email: Inderdeep.Dhaliwal[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Procedure:
• Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA)
Chest lymph node sampling procedure by EBUS
• Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA)
Chest lymph node sampling procedure by EUS

Locations

Country	Name	City	State
Canada	London Health Sciences Centre - London Regional Cancer Program	London	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Academic Medical Organization of Southwestern Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Identify the total number of lymph nodes sampled per procedure	Record the total number of lymph nodes sampled	2 years
Secondary	Identify the nodal stations sampled	Record the nodal stations that were sampled	2 years
Secondary	Determine the proportion of patients with complications of endoscopic procedure	Number of participants with complications versus number without	2 years