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

NCT ID: NCT04852588

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-09

Study Completion Date

2025-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Chest lymph node sampling procedure by EBUS

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

Intervention Type PROCEDURE

Chest lymph node sampling procedure by EUS

Interventions

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

Chest lymph node sampling procedure by EBUS

Intervention Type PROCEDURE

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

Chest lymph node sampling procedure by EUS

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academic Medical Organization of Southwestern Ontario

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Inderdeep Dhaliwal, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre, Lawson Health Research Institute

Locations

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London Health Sciences Centre - London Regional Cancer Program

London, Ontario, Canada

Site Status RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Inderdeep Dhaliwal, MD

Role: CONTACT

519-685-8500 ext. 76596

David Palma, MD

Role: CONTACT

519-685-8650

Facility Contacts

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Inderdeep Dhaliwal, MD

Role: primary

519-685-8500 ext. 76596

Alexander Louie, MD

Role: primary

416-480-4951

References

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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.

Reference Type DERIVED
PMID: 35484614 (View on PubMed)

Other Identifiers

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ReDA #11162

Identifier Type: OTHER

Identifier Source: secondary_id

ENDO-SABR

Identifier Type: -

Identifier Source: org_study_id

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