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

NCT02997449 | Unknown

• 2 other identifiers: STAGE2013_196
• Study Type: observational
• Target: 102
• Locations: 2 countries
• Sites: 4

Brief 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)).

Conditions

Non Small Cell Lung Cancer (NSCLC); Intrathoracic Nodal Staging

Keywords

Non-Small Cell Lung Cancer (NSCLC); Stereotactic ablative radiotherapy (SABR); Intrathoracic nodal staging

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Radiotherapy plan based on imaging (prior to endosonography) compared to the radiotherapy plan based on endosonography outcomes.

  1 month

• Incremental pathological confirmation of the diagnosis of lung cancer in patients with only a clinical diagnosis, following endosonographic staging.

  1 month

• Complication rate of a complete endosonographic procedure in this patients group

  1 month

Study Arms (1)

NSCLC, SABR, nodal staging

Patients with a clinical or pathological diagnosis of Non-Small Cell Lung Cancer (NSCLC), and who are medically inoperable or refuse surgery, are eligible if Stereotactic ablative radiotherapy (SABR) is recommended by a multi-disciplinary tumor board. All patients undergo complete mediastinal and hilar staging procedure (EBUS+EUS-B). Pre endoscopy imaging data will be compared with endosonography data.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with either established or suspected early-stage NSCLC who are medically inoperable, or who refuse surgery but are potential candidates for stereotactic ablative radiotherapy (SABR) with curative intent (provided no intrathoracic metastases are present)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (4)

NKI-AvL

Amsterdam, Netherlands

RECRUITING

VUMC

Amsterdam, Netherlands

RECRUITING

UMCN

Nijmegen, Netherlands

RECRUITING

Independent Endoscopy Unit, John Paul II Specialist Hospital

Krakow, Poland

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jouke T Annema, MD PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jouke T Annema, MD PhD

CONTACT

+31205664356; j.t.annema@amc.nl

Laurence M Crombag, MD

CONTACT

+31205664356; l.m.crombag@amc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: December 20, 2016
• Study Start: December 1, 2013
• Primary Completion: June 1, 2017
• Last Updated: December 20, 2016

Record last verified: 2016-12

Locations

PL (1); NL (3)