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

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ClinicalTrials.gov Identifier: NCT02997449
Recruitment Status : Unknown
Verified December 2016 by Prof J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was:  Recruiting
First Posted : December 20, 2016
Last Update Posted : December 20, 2016
Sponsor:
Information provided by (Responsible Party):
Prof J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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)).


Condition or disease
Non Small Cell Lung Cancer (NSCLC) Intrathoracic Nodal Staging

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Complete Endosonographic Intrathoracic Nodal Staging of Lung Cancer Patients in Whom Stereotactic Ablative Radiotherapy (SABR), is Considered
Study Start Date : December 2013
Estimated Primary Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort
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.



Primary Outcome Measures :
  1. Proportion of patients with change in nodal status based on imaging compared to nodal status based on endosonography. [ Time Frame: 0-6 months ]

    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.



Secondary Outcome Measures :
  1. Radiotherapy plan based on imaging (prior to endosonography) compared to the radiotherapy plan based on endosonography outcomes. [ Time Frame: 1 month ]
    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.

  2. Incremental pathological confirmation of the diagnosis of lung cancer in patients with only a clinical diagnosis, following endosonographic staging. [ Time Frame: 1 month ]
  3. Complication rate of a complete endosonographic procedure in this patients group [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02997449


Contacts
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Contact: Jouke T Annema, MD PhD +31205664356 j.t.annema@amc.nl
Contact: Laurence M Crombag, MD +31205664356 l.m.crombag@amc.nl

Locations
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Netherlands
NKI-AvL Recruiting
Amsterdam, Netherlands
Contact: W Buikhuisen, MD         
Contact: Wieneke Buikhuisen    +31-20-512 2958      
VUMC Recruiting
Amsterdam, Netherlands
Contact: Johannes Daniels, MD PhD         
Contact: Johannes Daniels, MD PhD    +31-20-4444444      
UMCN Recruiting
Nijmegen, Netherlands
Contact: O Schuurbiers, MD PhD    +31(0)243613648      
Principal Investigator: Olga Schuurbiers, MD         
Poland
Independent Endoscopy Unit, John Paul II Specialist Hospital Recruiting
Krakow, Poland
Contact: Artur Szlubowski, MD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Jouke T Annema, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Additional Information:

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Responsible Party: Prof J.T. Annema, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02997449    
Other Study ID Numbers: STAGE
2013_196 ( Other Identifier: Medical Ethics Review Committee Academic Medical Center )
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: December 2016
Keywords provided by Prof J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Non-Small Cell Lung Cancer (NSCLC)
Stereotactic ablative radiotherapy (SABR)
Intrathoracic nodal staging
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms