Non-Small Cell Lung CancerNCT04852588
Chest Lymph Node Sampling in Patients With Advanced Lung Cancer to be Treated With Curative-intent Radiation Treatment
A study testing Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA) and Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA) in people with Non-Small Cell Lung Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA) and Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesCanada
- Study dates
- 9 Nov 2021to 31 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindication to Endobronchial Ultrasound (EBUS) / Endoscopic Ultrasound (EUS)
- Unable to provide consent for EBUS/EUS
- Contraindication to chest radiotherapy
- Pregnant or lactating women
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
London Health Sciences Centre - London Regional Cancer Program
London, Ontario, N6A 5W9
Inderdeep Dhaliwal, MD, 519-685-8500 ext. 76596, Inderdeep.Dhaliwal@lhsc.on.ca
David Palma, MD
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Alexander Louie, MD, 416-480-4951, Alexander.Louie@sunnybrook.ca
Christine MacDonald, MD
About this study
Official title: 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA), Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA)
- Keywords
- Oligometastatic Non-Small Cell Lung Cancer, Stereotactic Ablative Radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA)Procedure or surgery
Chest lymph node sampling procedure by EBUS
Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA)Procedure or surgery
Chest lymph node sampling procedure by EUS
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | 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). Receives: Procedure: Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA); Procedure: Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (5)
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
Measured: 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
Measured: 2 years
Identify the total number of lymph nodes sampled per procedure
Record the total number of lymph nodes sampled
Measured: 2 years
Identify the nodal stations sampled
Record the nodal stations that were sampled
Measured: 2 years
Determine the proportion of patients with complications of endoscopic procedure
Number of participants with complications versus number without
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start9 Nov 2021
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Medical Organization of Southwestern Ontario
- Responsible party
- Sponsor
- Investigators
- Inderdeep Dhaliwal, MD, Principal investigator, London Health Sciences Centre, Lawson Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852588
- Sponsor's protocol ID
- ENDO-SABR
- Other IDs
- ReDA #11162
- Status last verified
- Mar 2025
- First submitted
- 12 Apr 2021
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35484614
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Nodal Staging in Oligometastatic Non-small Cell Lung Cancer (NSCLC) Being Treated With Stereotactic Ablative Radiotherapy (ENDO-SABR)
- ClinicalTrials.gov ID
- NCT04852588
- Acronym / sponsor ID
- ENDO-SABR
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Oligometastatic Non-Small Cell Lung Cancer, Stereotactic Ablative Radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Academic Medical Organization of Southwestern Ontario
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Procedure: Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA), Procedure: Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- Contraindication to Endobronchial Ultrasound (EBUS) / Endoscopic Ultrasound (EUS)
- Unable to provide consent for EBUS/EUS
- Contraindication to chest radiotherapy
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA)Chest lymph node sampling procedure by EBUS | Procedure or surgery | Treatment Arm |
| Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA)Chest lymph node sampling procedure by EUS | Procedure or surgery | Treatment Arm |
Primary outcome
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
5 secondary outcomes
Determine the proportion of patients with occult mediastinal metastasis
Time frame: 2 years
Determine the sensitivity and specificity of radiologic staging of hilar/mediastinal lymph nodes
Time frame: 2 years
Identify the total number of lymph nodes sampled per procedure
Time frame: 2 years
Identify the nodal stations sampled
Time frame: 2 years
Determine the proportion of patients with complications of endoscopic procedure
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Derived from this study: PubMed 35484614Dhaliwal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Inderdeep Dhaliwal, MD principal investigator
London Health Sciences Centre, Lawson Health Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA) and Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA) in people with Non-Small Cell Lung Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inderdeep Dhaliwal, MD (519-685-8500 ext. 76596, Inderdeep.Dhaliwal@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes to treatment intent and/or plan (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04852588, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.