<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02997449</url>
  </required_header>
  <id_info>
    <org_study_id>STAGE</org_study_id>
    <secondary_id>2013_196</secondary_id>
    <nct_id>NCT02997449</nct_id>
  </id_info>
  <brief_title>Complete Endosonographic Intrathoracic Nodal Staging of Lung Cancer Patients in Whom SABR is Considered</brief_title>
  <official_title>Complete Endosonographic Intrathoracic Nodal Staging of Lung Cancer Patients in Whom Stereotactic Ablative Radiotherapy (SABR), is Considered</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale: Accurate staging of lung cancer is important because it directs treatment and&#xD;
      determines prognosis. The development of Stereotactic Ablative Radiotherapy (SABR), has&#xD;
      revolutionized radiation therapy for early stage lung cancer and results demonstrate similar&#xD;
      outcomes in comparison to surgical resection of the lung tumor. The staging work-up program&#xD;
      for patients with a potentially resectable Non-Small-Cell Lung Cancer (NSCLC) includes at&#xD;
      least a computed tomography (CT) scan of the chest and integrated Positron Emission&#xD;
      Tomography - Computed Tomography (PET/CT) scans, and when indicated, invasive mediastinal&#xD;
      staging. However, patients who are treated with SABR do not routinely undergo the same nodal&#xD;
      staging work-up as do surgical candidates. As both surgery and SABR appear to achieve&#xD;
      comparable rates of local and regional tumor control, it appears only logical to perform a&#xD;
      similar staging work-up in all patients with early stage lung cancer who will be treated with&#xD;
      either of the two curative local modalities. In the past, a lack of invasive nodal sampling&#xD;
      before SABR was considered acceptable as invasive surgical staging (mediastinoscopy) was&#xD;
      widely considered the preferred procedure. However, with minimally invasive and safe&#xD;
      endosonography procedures now available, improved pre-treatment staging has become possible&#xD;
      for patient groups who are eligible for SABR, including those with significant comorbidities.&#xD;
&#xD;
      Hypothesis: Complete endosonographic (combined endobronchial and esophageal) staging of hilar&#xD;
      and mediastinal lymph nodes in patients with (suspected) non-small cell lung cancer (NSCLC)&#xD;
      will result in change of loco-regional nodal status in 20% of patients, in comparison to&#xD;
      staging by PET-CT alone.&#xD;
&#xD;
      Study population: Patients with either established or suspected early-stage NSCLC who are&#xD;
      medically inoperable, or who refuse surgery but are potential candidates for SABR with&#xD;
      curative intent (provided no intrathoracic metastases are present). Patients will undergo a&#xD;
      single scope complete mediastinal and hilar staging procedure (combined EndoBronchial&#xD;
      UltraSound (EBUS) and Transesophageal Endoscopic Ultrasound with EBUS scope (EUS-B)).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2013</start_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Proportion of patients with change in nodal status based on imaging compared to nodal status based on endosonography.</measure>
    <time_frame>0-6 months</time_frame>
    <description>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.&#xD;
The sensitivities, negative predictive values (NPV) and positive predictive values (PPV) for endosonography and PET-CT imaging will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiotherapy plan based on imaging (prior to endosonography) compared to the radiotherapy plan based on endosonography outcomes.</measure>
    <time_frame>1 month</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incremental pathological confirmation of the diagnosis of lung cancer in patients with only a clinical diagnosis, following endosonographic staging.</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate of a complete endosonographic procedure in this patients group</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">102</enrollment>
  <condition>Non Small Cell Lung Cancer (NSCLC)</condition>
  <condition>Intrathoracic Nodal Staging</condition>
  <arm_group>
    <arm_group_label>NSCLC, SABR, nodal staging</arm_group_label>
    <description>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.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with either established or suspected early-stage NSCLC who are medically&#xD;
        inoperable, or who refuse surgery but are potential candidates for stereotactic ablative&#xD;
        radiotherapy (SABR) with curative intent (provided no intrathoracic metastases are present)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Proven, or highly suspected, non-small cell lung cancer (NSCLC)&#xD;
&#xD;
          -  Absence of distant metastases based on PET-CT&#xD;
&#xD;
          -  Stereotactic ablative radiotherapy (SABR) with curative intent is contemplated&#xD;
&#xD;
          -  One of the following features based on PET-CT:&#xD;
&#xD;
          -  Centrally located clinical T1-T2 N0 tumor&#xD;
&#xD;
          -  Peripheral located clinical T2 N0 tumor&#xD;
&#xD;
          -  Suspicion of N1- N2 disease based on either size (short axis &gt; 10mm CT) or FDG uptake&#xD;
&#xD;
          -  Non-FDG avid primary lung tumor and lymph nodes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medically operable patients with a resectable lung tumor (unless SABR is the explicit&#xD;
             preference of the patients or treating physicians preference).&#xD;
&#xD;
          -  Bulky nodal disease based on PET-CT&#xD;
&#xD;
          -  Contra-indications for endosonography and / or bronchoscopy&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Age under 18&#xD;
&#xD;
          -  No informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jouke T Annema, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jouke T Annema, MD PhD</last_name>
    <phone>+31205664356</phone>
    <email>j.t.annema@amc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laurence M Crombag, MD</last_name>
    <phone>+31205664356</phone>
    <email>l.m.crombag@amc.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>NKI-AvL</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>W Buikhuisen, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Wieneke Buikhuisen</last_name>
      <phone>+31-20-512 2958</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>VUMC</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Johannes Daniels, MD PhD</last_name>
    </contact>
    <contact_backup>
      <last_name>Johannes Daniels, MD PhD</last_name>
      <phone>+31-20-4444444</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>UMCN</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>O Schuurbiers, MD PhD</last_name>
      <phone>+31(0)243613648</phone>
    </contact>
    <investigator>
      <last_name>Olga Schuurbiers, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Independent Endoscopy Unit, John Paul II Specialist Hospital</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Artur Szlubowski, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
    <country>Poland</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>October 17, 2014</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>December 15, 2016</last_update_submitted>
  <last_update_submitted_qc>December 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>Prof J.T. Annema</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <keyword>Non-Small Cell Lung Cancer (NSCLC)</keyword>
  <keyword>Stereotactic ablative radiotherapy (SABR)</keyword>
  <keyword>Intrathoracic nodal staging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02997449
org study id: STAGE
secondary id: 2013_196
nct id: NCT02997449
lead sponsor: 
has dmc: No
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)).
observational model: Cohort
time perspective: Prospective
measure: Proportion of patients with change in nodal status based on imaging compared to nodal status based on endosonography.
time frame: 0-6 months
description: 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.
measure: Radiotherapy plan based on imaging (prior to endosonography) compared to the radiotherapy plan based on endosonography outcomes.
time frame: 1 month
description: 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.
measure: Incremental pathological confirmation of the diagnosis of lung cancer in patients with only a clinical diagnosis, following endosonographic staging.
time frame: 1 month
measure: Complication rate of a complete endosonographic procedure in this patients group
time frame: 1 month
arm group label: NSCLC, SABR, nodal staging
description: 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.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jouke T Annema, MD PhD
role: Principal Investigator
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
last name: Jouke T Annema, MD PhD
phone: +31205664356
email: j.t.annema@amc.nl
last name: Laurence M Crombag, MD
phone: +31205664356
email: l.m.crombag@amc.nl
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: Netherlands
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Prof J.T. Annema
investigator title: MD PhD
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung