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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04852588
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : November 17, 2021
Sponsor:
Collaborator:
Academic Medical Organization of Southwestern Ontario
Information provided by (Responsible Party):
Lawson Health Research Institute

Study Description
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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.


Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Procedure: Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA) Procedure: Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Nodal Staging in Oligometastatic Non-small Cell Lung Cancer (NSCLC) Being Treated With Stereotactic Ablative Radiotherapy (ENDO-SABR)
Actual Study Start Date : November 9, 2021
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04852588


Contacts
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Contact: Inderdeep Dhaliwal, MD 519-685-8500 ext 76596 Inderdeep.Dhaliwal@lhsc.on.ca
Contact: David Palma, MD 519-685-8650 David.Palma@lhsc.on.ca

Locations
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Canada, Ontario
London Health Sciences Centre - London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Inderdeep Dhaliwal, MD    519-685-8500 ext 76596    Inderdeep.Dhaliwal@lhsc.on.ca   
Sub-Investigator: David Palma, MD         
Sub-Investigator: Michael Mitchell, MD         
Sub-Investigator: Mehdi Qiabi, MD         
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Alexander Louie, MD    416-480-4951    Alexander.Louie@sunnybrook.ca   
Sub-Investigator: Christine MacDonald, MD         
Sub-Investigator: Harvey Wong, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Academic Medical Organization of Southwestern Ontario
Investigators
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Principal Investigator: Inderdeep Dhaliwal, MD London Health Sciences Centre, Lawson Health Research Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT04852588    
Other Study ID Numbers: ENDO-SABR
ReDA #11162 ( Other Identifier: Lawson Health Research Institute )
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: November 17, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lawson Health Research Institute:
Oligometastatic Non-Small Cell Lung Cancer
Stereotactic Ablative Radiotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms