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Recruiting NCT04852588

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

No phase Interventional Non-Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA), Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA).
Who it may be relevant to
Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Endoscopic Nodal Staging in Oligometastatic Non-small Cell Lung Cancer (NSCLC) Being Treated With Stereotactic Ablative Radiotherapy (ENDO-SABR)

Overview

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.

Interventions

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

Primary outcome measures

  • Changes to treatment intent and/or plan [Time frame: 2 years]
Secondary outcome measures (5)
  • 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]

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.
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 2 centers
  • London Health Sciences Centre - London Regional Cancer Program — London
  • Sunnybrook Health Sciences Centre — Toronto

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. PMID 35484614

Identifiers

NCT: NCT04852588 · ENDO-SABR · ReDA #11162

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗