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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04852588
Other study ID # ENDO-SABR
Secondary ID ReDA #11162
Status Recruiting
Phase N/A
First received
Last updated
Start date November 9, 2021
Est. completion date May 31, 2025

Study information

Verified date February 2024
Source Lawson Health Research Institute
Contact Inderdeep Dhaliwal, MD
Phone 519-685-8500
Email Inderdeep.Dhaliwal@lhsc.on.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 29
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA)
Chest lymph node sampling procedure by EBUS
Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA)
Chest lymph node sampling procedure by EUS

Locations

Country Name City State
Canada London Health Sciences Centre - London Regional Cancer Program London Ontario
Canada Sunnybrook Health Sciences Centre Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
Lawson Health Research Institute Academic Medical Organization of Southwestern Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 2 years
Secondary Determine the sensitivity and specificity of radiologic staging of hilar/mediastinal lymph nodes Nodal staging on imaging alone versus nodal staging after sampling 2 years
Secondary Identify the total number of lymph nodes sampled per procedure Record the total number of lymph nodes sampled 2 years
Secondary Identify the nodal stations sampled Record the nodal stations that were sampled 2 years
Secondary Determine the proportion of patients with complications of endoscopic procedure Number of participants with complications versus number without 2 years
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