Complete Endosonographic Intrathoracic Nodal Staging of Lung Cancer Patients in Whom SABR is Considered

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02997449
• Other study ID #: STAGE
• Secondary ID: 2013_196
• Status: Recruiting
• Phase: N/A
• First received: October 17, 2014
• Last updated: December 15, 2016
• Start date: December 2013

Study information

• Verified date: December 2016
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Jouke T Annema, MD PhD
• Phone: +31205664356
• Email: j.t.annema[@]amc.nl
• Is FDA regulated: No
• Health authority: The Netherlands: Central Committee on Research inv. Human Subjects
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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)).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Proven, or highly suspected, non-small cell lung cancer (NSCLC)

• Absence of distant metastases based on PET-CT

• Stereotactic ablative radiotherapy (SABR) with curative intent is contemplated

• One of the following features based on PET-CT:

• Centrally located clinical T1-T2 N0 tumor

• Peripheral located clinical T2 N0 tumor

• Suspicion of N1- N2 disease based on either size (short axis > 10mm CT) or FDG uptake

• Non-FDG avid primary lung tumor and lymph nodes

Exclusion Criteria:

• Medically operable patients with a resectable lung tumor (unless SABR is the explicit preference of the patients or treating physicians preference).

• Bulky nodal disease based on PET-CT

• Contra-indications for endosonography and / or bronchoscopy

• Pregnancy

• Age under 18

• No informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Intrathoracic Nodal Staging
• Lung Neoplasms
• Non Small Cell Lung Cancer (NSCLC)

Locations

Country	Name	City	State
Netherlands	NKI-AvL	Amsterdam
Netherlands	VUMC	Amsterdam
Netherlands	UMCN	Nijmegen
Poland	Independent Endoscopy Unit, John Paul II Specialist Hospital	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Countries where clinical trial is conducted

Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with change in nodal status based on imaging compared to nodal status based on endosonography.	Prior to endoscopy the nodal status (single outcome measure either N0,N1,N2,N3) will be defined based on (PET) CT imaging. After complete endosonographic staging (EBUS+EUS-B) of the hilus and mediastinum again the nodal status will be defined (single outcome measure either N0,N1,N2,N3) based on endosonography findings.; The sensitivities, negative predictive values (NPV) and positive predictive values (PPV) for endosonography and PET-CT imaging will be calculated.	0-6 months	No
Secondary	Radiotherapy plan based on imaging (prior to endosonography) compared to the radiotherapy plan based on endosonography outcomes.	The radiotherapist will make a radiation plan (Gross Tumor Volume (GTV) primary tumor, internal target volume (ITV) primary tumor and planning target volume (PTV) primary tumor) based on (PET) CT imaging prior to endosonography. After endosonography the radiotherapist will make another radiotherapy plan based on endosonography staging results. The proportions of changed radiotherapy plans per patient basis will be calculated.	1 month	No
Secondary	Incremental pathological confirmation of the diagnosis of lung cancer in patients with only a clinical diagnosis, following endosonographic staging.		1 month	No
Secondary	Complication rate of a complete endosonographic procedure in this patients group		1 month	Yes