Clinical trial NCT04852588: 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
Overall status: RECRUITING
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Keywords: Oligometastatic Non-Small Cell Lung Cancer
Stereotactic Ablative Radiotherapy
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Academic Medical Organization of Southwestern Ontario
First posted: 2021-04-21
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

  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

Primary outcomes:
measure: Changes to treatment intent and/or plan
timeFrame: 2 years
Secondary outcomes:
measure: Determine the proportion of patients with occult mediastinal metastasis
timeFrame: 2 years
measure: Determine the sensitivity and specificity of radiologic staging of hilar/mediastinal lymph nodes
timeFrame: 2 years
measure: Identify the total number of lymph nodes sampled per procedure
timeFrame: 2 years
measure: Identify the nodal stations sampled
timeFrame: 2 years
measure: Determine the proportion of patients with complications of endoscopic procedure
timeFrame: 2 years
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre - London Regional Cancer Program
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre, Lawson Health Research Institute
name: Inderdeep Dhaliwal, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.