<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/NCT02228356</url>
  </required_header>
  <id_info>
    <org_study_id>BUN143201215117</org_study_id>
    <secondary_id>BUN143201215117</secondary_id>
    <nct_id>NCT02228356</nct_id>
  </id_info>
  <brief_title>Non-interventional Observational Study of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Cancer</brief_title>
  <official_title>Non-interventional Observational Study of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitair Ziekenhuis Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</source>
  <brief_summary>
    <textblock>
      The investigators recently published 2 phase II trials on the use of helical tomotherapy for&#xD;
      oligometastatic colorectal cancer [1,2]. Despite a dose increase from 40 to 50 Gy, delivered&#xD;
      in 2 weeks time, the one-year local control was 54% only [1,2]. The high local failure rate&#xD;
      is probably the result of geographical misses due to tumor motion and a biologically&#xD;
      effective dose (BED) of &lt; 100 Gy. The current study will investigate whether the one-year&#xD;
      local control rate can be improved to 70%, using respiration correlated CT to individualize&#xD;
      the margin needed to account for tumor motion, to avoid geographical miss, together with a&#xD;
      Monte Carlo or collapsed cone dose calculation algorithm delivering 50 Gy to the 80% isodose,&#xD;
      allowing higher doses in the tumor core. As the concept of an internal target volume (ITV)&#xD;
      may result in large margins for patients displaying metastases in high mobile organs, such as&#xD;
      liver and lung, which may lead to exposure of a relatively high dose to a large volume of&#xD;
      normal tissue, dynamic tumor tracking by the VERO SBRT system will be applied in those&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>One year local control</measure>
    <time_frame>one year post radiotherapy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute toxicity</measure>
    <time_frame>Up to 3 months post radiotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>3 to 36 months post Radiotherapy</time_frame>
    <description>Overall survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>3 to 36 months post Radiotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late toxicity</measure>
    <time_frame>3 to 36 months post Radiotherapy</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Neoplasm Metastasis</condition>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic Body Radiation Therapy</intervention_name>
    <description>Stereotactic Body Radiation Therapy with either Dynamic Tumor Tracking/Internal Target Volume approach on the Vero machine, and/or Internal Target Volume approach on the Tomotherapy machine.</description>
    <other_name>Vero</other_name>
    <other_name>Tomotherapy</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with metastatic cancer from any primary origin and no more than 5 metastases.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with metastatic cancer from any primary origin and no more than 5 metastases&#xD;
             on CT--scan&#xD;
&#xD;
          2. Primary tumor treated with curative intention (surgery, radiotherapy,&#xD;
             chemoradiotherapy)&#xD;
&#xD;
          3. Functional liver volume &gt; 1000cc in case of liver metastases and a lung diffusion&#xD;
             capacity for carbon monoxide (DLCO) of &gt; 30% if lung mets&#xD;
&#xD;
          4. No Child B or C liver cirrhosis&#xD;
&#xD;
          5. No systemic treatment within 1 month before initiation of radiotherapy&#xD;
&#xD;
          6. No contra-indications for radiation of all metastatic disease (= no violation of&#xD;
             constraints of organs at risk (OAR))&#xD;
&#xD;
          7. No metastases from another carcinoma&#xD;
&#xD;
          8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2&#xD;
&#xD;
          9. Age &gt; 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benedikt Engels, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robbe Van den Begin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark De Ridder, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Benedikt Engels, MD, PhD</last_name>
    <phone>+324776041</phone>
    <email>benedikt.engels@uzbrussel.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cleo Wauters, MD</last_name>
    <phone>+324776041</phone>
    <email>cleo.wauters@uzbrussel.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UZ Brussel Radiotherapie dienst</name>
      <address>
        <city>Jette</city>
        <state>Brussel</state>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Benedikt Engels, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mark De Ridder, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Robbe Van Den Begin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Harijati Versmessen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Engels B, Everaert H, Gevaert T, Duchateau M, Neyns B, Sermeus A, Tournel K, Verellen D, Storme G, De Ridder M. Phase II study of helical tomotherapy for oligometastatic colorectal cancer. Ann Oncol. 2011 Feb;22(2):362-8. doi: 10.1093/annonc/mdq385. Epub 2010 Aug 4.</citation>
    <PMID>20685718</PMID>
  </reference>
  <reference>
    <citation>Engels B, Gevaert T, Everaert H, De Coninck P, Sermeus A, Christian N, Storme G, Verellen D, De Ridder M. Phase II study of helical tomotherapy in the multidisciplinary treatment of oligometastatic colorectal cancer. Radiat Oncol. 2012 Mar 16;7:34. doi: 10.1186/1748-717X-7-34.</citation>
    <PMID>22423615</PMID>
  </reference>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>May 10, 2016</last_update_submitted>
  <last_update_submitted_qc>May 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitair Ziekenhuis Brussel</investigator_affiliation>
    <investigator_full_name>Benedikt Engels, MD, PhD</investigator_full_name>
    <investigator_title>Radiation Oncologist</investigator_title>
  </responsible_party>
  <keyword>Neoplasm Metastasis</keyword>
  <keyword>oligometastatic cancer</keyword>
  <keyword>Stereotactic Body Radiation Therapy</keyword>
  <keyword>SBRT</keyword>
  <keyword>Real-time Tumor Tracking (RTTT)</keyword>
  <keyword>ITV</keyword>
  <keyword>Internal Target Volume</keyword>
  <keyword>Respiratory Motion Management</keyword>
  <keyword>Image-guided Radiotherapy</keyword>
  <keyword>IGRT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</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/NCT02228356
org study id: BUN143201215117
secondary id: BUN143201215117
nct id: NCT02228356
lead sponsor: 
The investigators recently published 2 phase II trials on the use of helical tomotherapy for
      oligometastatic colorectal cancer [1,2]. Despite a dose increase from 40 to 50 Gy, delivered
      in 2 weeks time, the one-year local control was 54% only [1,2]. The high local failure rate
      is probably the result of geographical misses due to tumor motion and a biologically
      effective dose (BED) of < 100 Gy. The current study will investigate whether the one-year
      local control rate can be improved to 70%, using respiration correlated CT to individualize
      the margin needed to account for tumor motion, to avoid geographical miss, together with a
      Monte Carlo or collapsed cone dose calculation algorithm delivering 50 Gy to the 80% isodose,
      allowing higher doses in the tumor core. As the concept of an internal target volume (ITV)
      may result in large margins for patients displaying metastases in high mobile organs, such as
      liver and lung, which may lead to exposure of a relatively high dose to a large volume of
      normal tissue, dynamic tumor tracking by the VERO SBRT system will be applied in those
      patients.
observational model: Cohort
time perspective: Prospective
measure: One year local control
time frame: one year post radiotherapy
measure: Acute toxicity
time frame: Up to 3 months post radiotherapy
measure: Survival
time frame: 3 to 36 months post Radiotherapy
description: Overall survival
measure: Progression Free Survival
time frame: 3 to 36 months post Radiotherapy
measure: Late toxicity
time frame: 3 to 36 months post Radiotherapy
intervention type: Radiation
intervention name: Stereotactic Body Radiation Therapy
description: Stereotactic Body Radiation Therapy with either Dynamic Tumor Tracking/Internal Target Volume approach on the Vero machine, and/or Internal Target Volume approach on the Tomotherapy machine.
other name: Vero
other name: Tomotherapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Benedikt Engels, MD, PhD
role: Principal Investigator
affiliation: Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel
last name: Robbe Van den Begin, MD
role: Principal Investigator
affiliation: Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel
last name: Mark De Ridder, MD, PhD
role: Principal Investigator
affiliation: Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel
last name: Benedikt Engels, MD, PhD
phone: +324776041
email: benedikt.engels@uzbrussel.be
last name: Cleo Wauters, MD
phone: +324776041
email: cleo.wauters@uzbrussel.be
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
investigator: 
country: Belgium
citation: Engels B, Everaert H, Gevaert T, Duchateau M, Neyns B, Sermeus A, Tournel K, Verellen D, Storme G, De Ridder M. Phase II study of helical tomotherapy for oligometastatic colorectal cancer. Ann Oncol. 2011 Feb;22(2):362-8. doi: 10.1093/annonc/mdq385. Epub 2010 Aug 4.
PMID: 20685718
citation: Engels B, Gevaert T, Everaert H, De Coninck P, Sermeus A, Christian N, Storme G, Verellen D, De Ridder M. Phase II study of helical tomotherapy in the multidisciplinary treatment of oligometastatic colorectal cancer. Radiat Oncol. 2012 Mar 16;7:34. doi: 10.1186/1748-717X-7-34.
PMID: 22423615
responsible party type: Principal Investigator
investigator affiliation: Universitair Ziekenhuis Brussel
investigator full name: Benedikt Engels, MD, PhD
investigator title: Radiation Oncologist
mesh term: Neoplasm Metastasis