Minimally invasive lymph node staging for lung cancer patients before radiation therapy
Endobronchial Ultrasound-guided Transbronchial Needle Aspiration for Lymph Node Staging in Patients With Non-small Cell Lung Cancer Pursuing Stereotactic Body Radiotherapy (SBRT)
This study is testing a new way to check lymph nodes in lung cancer patients to see if it helps them get a less invasive radiation treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT01786590 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for staging lymph nodes in patients with non-small cell lung cancer who are candidates for stereotactic body radiation therapy (SBRT). Patients will undergo imaging tests, followed by the EBUS-TBNA procedure to assess lymph node involvement. The results from EBUS-TBNA will be compared to previous imaging results to determine the accuracy of staging. Successful staging will allow patients who are negative for lymph node metastasis to receive SBRT, a less invasive treatment option.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed non-small cell lung cancer who are medically inoperable and require lymph node staging prior to SBRT.
Not a fit: Patients who are not medically fit for bronchoscopy or those with active infections or other serious health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive and more accurate method for staging lung cancer, leading to better treatment options for patients.
How similar studies have performed: Previous studies have shown that EBUS-TBNA is a promising technique for lymph node staging in lung cancer, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years or older 2. Patients with confirmed lung cancer who require EBUS-TBNA as part of their staging investigations of the mediastinum and hilum prior to SBRT 3. Performance status score (WHO/ECOG) of 0-2. 4. Cytological or histological proof of non-small cell cancer 5. Stage T1-2 disease, with no evidence of distant metastasis 6. Patients are screened by both computed tomography (CT) and positron emission tomography (PET) 7. Medically inoperable for surgical resection 8. Patients who refused surgery Exclusion Criteria: 1. Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy 2. Active systemic, pulmonary, or pericardial infection 3. Patients who are pregnant or lactating 4. Patients with plans to receive conventional radiotherapy, chemotherapy, biological therapy, vaccine therapy, or surgery as treatment (except at disease progression). 5. Inability to give informed consent
Where this trial is running
Toronto, Ontario
- Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Kazuhiro Yasufuku, MD — Uhn
- Study coordinator: Judy McConnell
- Email: judy.mcconnell@uhn.ca
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.