Chest Lymph Node Sampling in Patients With Advanced Lung Cancer to be Treated With Curative-intent Radiation Treatment
Endoscopic Nodal Staging in Oligometastatic Non-small Cell Lung Cancer (NSCLC) Being Treated With Stereotactic Ablative Radiotherapy (ENDO-SABR)
2 other identifiers
interventional
29
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable nonsmall-cell-lung-cancer
Started Nov 2021
Typical duration for not_applicable nonsmall-cell-lung-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2021
CompletedFirst Posted
Study publicly available on registry
April 21, 2021
CompletedStudy Start
First participant enrolled
November 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedMarch 28, 2025
March 1, 2025
3.6 years
April 12, 2021
March 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 years
Secondary Outcomes (5)
Determine the proportion of patients with occult mediastinal metastasis
2 years
Determine the sensitivity and specificity of radiologic staging of hilar/mediastinal lymph nodes
2 years
Identify the total number of lymph nodes sampled per procedure
2 years
Identify the nodal stations sampled
2 years
Determine the proportion of patients with complications of endoscopic procedure
2 years
Study Arms (1)
Treatment Arm
EXPERIMENTALSmall 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).
Interventions
Chest lymph node sampling procedure by EBUS
Chest lymph node sampling procedure by EUS
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Contraindication to Endobronchial Ultrasound (EBUS) / Endoscopic Ultrasound (EUS)
- Unable to provide consent for EBUS/EUS
- Contraindication to chest radiotherapy
- Pregnant or lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
London Health Sciences Centre - London Regional Cancer Program
London, Ontario, N6A 5W9, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Related Publications (1)
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.
PMID: 35484614DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Inderdeep Dhaliwal, MD
London Health Sciences Centre, Lawson Health Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2021
First Posted
April 21, 2021
Study Start
November 9, 2021
Primary Completion
May 31, 2025
Study Completion
May 31, 2025
Last Updated
March 28, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share