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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 29
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Inderdeep Dhaliwal, MD; Phone Number: 76596 519-685-8500; Email: Inderdeep.Dhaliwal@lhsc.on.ca
• Study Contact Backup: Name: David Palma, MD; Phone Number: 519-685-8650; Email: David.Palma@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • London Health Sciences Centre - London Regional Cancer Program
      • Contact: Inderdeep Dhaliwal, MD; Phone Number: 76596 519-685-8500; Email: Inderdeep.Dhaliwal@lhsc.on.ca
      • Sub-Investigator: David Palma, MD
      • Sub-Investigator: Michael Mitchell, MD
      • Sub-Investigator: Mehdi Qiabi, MD
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Health Sciences Centre
      • Contact: Alexander Louie, MD; Phone Number: 416-480-4951; Email: Alexander.Louie@sunnybrook.ca
      • Sub-Investigator: Christine MacDonald, MD
      • Sub-Investigator: Harvey Wong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; 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); Chest lymph node sampling procedure by EBUS; Procedure: Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA); Chest lymph node sampling procedure by EUS

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Academic Medical Organization of Southwestern Ontario
• Investigators: Principal Investigator: Inderdeep Dhaliwal, MD, London Health Sciences Centre, Lawson Health Research Institute

Publications and helpful links

General Publications

• Dhaliwal I, Kassirian S, Mitchell MA, Qiabi M, Warner A, Louie AV, Wong HH, McDonald CM, Rajchgot J, Palma DA. Endoscopic nodal staging in oligometastatic non-small cell lung cancer (NSCLC) being treated with stereotactic ablative radiotherapy (ENDO-SABR). BMC Cancer. 2022 Apr 28;22(1):468. doi: 10.1186/s12885-022-09563-8.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Stereotactic Ablative Radiotherapy; Oligometastatic Non-Small Cell Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ENDO-SABR; ReDA #11162 (Other Identifier: Lawson Health Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No