Non Small Cell Lung Cancer (NSCLC) Clinical Trial
Official title:
Complete Endosonographic Intrathoracic Nodal Staging of Lung Cancer Patients in Whom Stereotactic Ablative Radiotherapy (SABR), is Considered
Rationale: Accurate staging of lung cancer is important because it directs treatment and
determines prognosis. The development of Stereotactic Ablative Radiotherapy (SABR), has
revolutionized radiation therapy for early stage lung cancer and results demonstrate similar
outcomes in comparison to surgical resection of the lung tumor. The staging work-up program
for patients with a potentially resectable Non-Small-Cell Lung Cancer (NSCLC) includes at
least a computed tomography (CT) scan of the chest and integrated Positron Emission
Tomography - Computed Tomography (PET/CT) scans, and when indicated, invasive mediastinal
staging. However, patients who are treated with SABR do not routinely undergo the same nodal
staging work-up as do surgical candidates. As both surgery and SABR appear to achieve
comparable rates of local and regional tumor control, it appears only logical to perform a
similar staging work-up in all patients with early stage lung cancer who will be treated
with either of the two curative local modalities. In the past, a lack of invasive nodal
sampling before SABR was considered acceptable as invasive surgical staging
(mediastinoscopy) was widely considered the preferred procedure. However, with minimally
invasive and safe endosonography procedures now available, improved pre-treatment staging
has become possible for patient groups who are eligible for SABR, including those with
significant comorbidities.
Hypothesis: Complete endosonographic (combined endobronchial and esophageal) staging of
hilar and mediastinal lymph nodes in patients with (suspected) non-small cell lung cancer
(NSCLC) will result in change of loco-regional nodal status in 20% of patients, in
comparison to staging by PET-CT alone.
Study population: Patients with either established or suspected early-stage NSCLC who are
medically inoperable, or who refuse surgery but are potential candidates for SABR with
curative intent (provided no intrathoracic metastases are present). Patients will undergo a
single scope complete mediastinal and hilar staging procedure (combined EndoBronchial
UltraSound (EBUS) and Transesophageal Endoscopic Ultrasound with EBUS scope (EUS-B)).
n/a
Observational Model: Cohort, Time Perspective: Prospective
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