Recruiting

SABR

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT04852588

Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA)

Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA)

Study Details

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.

Conditions

Non-Small Cell Lung Cancer

Study ID

NCT04852588

Start date

Nov 9, 2021

Status verified date

Mar, 2025

Completion date

May 31, 2025

Anticipated

Primary completion date

May 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

29 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

Interventions

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

Primary outcome measure

  • Changes to treatment intent and/or plan [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Inderdeep Dhaliwal, MD

519-685-8500Inderdeep.Dhaliwal@lhsc.on.ca

David Palma, MD

519-685-8650David.Palma@lhsc.on.ca

Locations

London Health Sciences Centre - London Regional Cancer Program

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Inderdeep Dhaliwal, MD

519-685-8500Inderdeep.Dhaliwal@lhsc.on.ca

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Alexander Louie, MD

416-480-4951Alexander.Louie@sunnybrook.ca

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Mar 28, 2025

Last verified

Mar, 2025

Keywords

  • Oligometastatic Non-Small Cell Lung Cancer
  • Stereotactic Ablative Radiotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2025-03-28.