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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA)
Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA)
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Oligometastatic Non-Small Cell Lung Cancer, Stereotactic Ablative Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • London Health Sciences Centre - London Regional Cancer ProgramRecruiting
  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Determine the sensitivity and specificity of radiologic staging of hilar/mediastinal lymph nodes
Nodal staging on imaging alone versus nodal staging after sampling
Identify the total number of lymph nodes sampled per procedure
Record the total number of lymph nodes sampled
Identify the nodal stations sampled
Record the nodal stations that were sampled
Determine the proportion of patients with complications of endoscopic procedure
Number of participants with complications versus number without

Full Information

First Posted
April 12, 2021
Last Updated
March 7, 2023
Sponsor
Lawson Health Research Institute
Collaborators
Academic Medical Organization of Southwestern Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT04852588
Brief Title
Chest Lymph Node Sampling in Patients With Advanced Lung Cancer to be Treated With Curative-intent Radiation Treatment
Official Title
Endoscopic Nodal Staging in Oligometastatic Non-small Cell Lung Cancer (NSCLC) Being Treated With Stereotactic Ablative Radiotherapy (ENDO-SABR)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Academic Medical Organization of Southwestern Ontario

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Oligometastatic Non-Small Cell Lung Cancer, Stereotactic Ablative Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA)
Intervention Description
Chest lymph node sampling procedure by EBUS
Intervention Type
Procedure
Intervention Name(s)
Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA)
Intervention Description
Chest lymph node sampling procedure by EUS
Primary Outcome Measure Information:
Title
Changes to treatment intent and/or plan
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Determine the proportion of patients with occult mediastinal metastasis
Description
Pre-staging treatment planning anticipated lymph nodes to be treated compared to post staging lymph nodes to be treated
Time Frame
2 years
Title
Determine the sensitivity and specificity of radiologic staging of hilar/mediastinal lymph nodes
Description
Nodal staging on imaging alone versus nodal staging after sampling
Time Frame
2 years
Title
Identify the total number of lymph nodes sampled per procedure
Description
Record the total number of lymph nodes sampled
Time Frame
2 years
Title
Identify the nodal stations sampled
Description
Record the nodal stations that were sampled
Time Frame
2 years
Title
Determine the proportion of patients with complications of endoscopic procedure
Description
Number of participants with complications versus number without
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Inderdeep Dhaliwal, MD
Phone
519-685-8500
Ext
76596
Email
Inderdeep.Dhaliwal@lhsc.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
David Palma, MD
Phone
519-685-8650
Email
David.Palma@lhsc.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inderdeep Dhaliwal, MD
Organizational Affiliation
London Health Sciences Centre, Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre - London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inderdeep Dhaliwal, MD
Phone
519-685-8500
Ext
76596
Email
Inderdeep.Dhaliwal@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
David Palma, MD
First Name & Middle Initial & Last Name & Degree
Michael Mitchell, MD
First Name & Middle Initial & Last Name & Degree
Mehdi Qiabi, MD
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Louie, MD
Phone
416-480-4951
Email
Alexander.Louie@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Christine MacDonald, MD
First Name & Middle Initial & Last Name & Degree
Harvey Wong, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35484614
Citation
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.
Results Reference
derived

Learn more about this trial

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

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