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NCT Number: NCT04852588

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre - London Regional Cancer Program, London, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

Chest lymph node sampling procedure by EBUS

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

Procedure

Chest lymph node sampling procedure by EUS

Primary outcomes

  1. Changes to treatment intent and/or plan

    Time frame: 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 outcomes

  1. Determine the proportion of patients with occult mediastinal metastasis

    Time frame: 2 years

    Pre-staging treatment planning anticipated lymph nodes to be treated compared to post staging lymph nodes to be treated

  2. Determine the sensitivity and specificity of radiologic staging of hilar/mediastinal lymph nodes

    Time frame: 2 years

    Nodal staging on imaging alone versus nodal staging after sampling

  3. Identify the total number of lymph nodes sampled per procedure

    Time frame: 2 years

    Record the total number of lymph nodes sampled

  4. Identify the nodal stations sampled

    Time frame: 2 years

    Record the nodal stations that were sampled

  5. Determine the proportion of patients with complications of endoscopic procedure

    Time frame: 2 years

    Number of participants with complications versus number without

Study contacts

Contact information is provided by the study sponsor or research team.

David Palma, MD

CONTACT

[email protected]

519-685-8650

Inderdeep Dhaliwal, MD

CONTACT

[email protected]

519-685-8500 ext. 76596

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Academic Medical Organization of Southwestern Ontario

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 21, 2021
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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