<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/NCT03818503</url>
  </required_header>
  <id_info>
    <org_study_id>EORTC-1811</org_study_id>
    <nct_id>NCT03818503</nct_id>
  </id_info>
  <brief_title>E²-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe</brief_title>
  <acronym>E²-RADIatE</acronym>
  <official_title>E²-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Organisation for Research and Treatment of Cancer - EORTC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European Organisation for Research and Treatment of Cancer - EORTC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is the collection of real-world data of cancer patients treated with&#xD;
      radiotherapy, to support radiotherapy research and to provide evidence of the role of&#xD;
      radiation oncology in a multidisciplinary approach. This is an open ended prospective&#xD;
      non-interventional non-therapeutic multi-cohort study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 24, 2019</start_date>
  <completion_date type="Anticipated">April 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2024</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>5 Years</target_duration>
  <primary_outcome>
    <measure>Number of patients treated with radiotherapy enrolled in the program</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease free survival</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loco-regional control</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastasis free survival</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events related to radiotherapy</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>OligoCare</arm_group_label>
    <description>Patients with oligometastatic disease treated with radical radiotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ReCare</arm_group_label>
    <description>Patients treated with high-dose Re-irradiation</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with various tumor types planned to be treated with radiation therapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically confirmed cancer.&#xD;
&#xD;
          -  Written informed consent for E²-RADIatE according to applicable legal and ethical&#xD;
             requirements&#xD;
&#xD;
          -  Planned use of radiotherapy&#xD;
&#xD;
          -  Eligibility of the patient confirmed for at least one cohort confirmed&#xD;
&#xD;
          -  Patients of 12 years and older&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>EORTC HQ</last_name>
    <phone>+32 2 774 1611</phone>
    <email>1811@eortc.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medical University of Graz - Radio-oncology</name>
      <address>
        <city>Graz</city>
        <zip>AT 8036</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tanja Langsenlehner</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ordensklinikum Linz-Barmherzige Schwestern</name>
      <address>
        <city>Linz</city>
        <zip>AT 4010</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hans Geinitz</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH unikliniken</name>
      <address>
        <city>Vienna</city>
        <zip>AT 1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joachim Widder</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Onze Lieve Vrouw Ziekenhuis</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luc Verbeke</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xavier Geets</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yolande Lievens</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>AZ Groeninge Kortrijk - Campus Kennedylaan</name>
      <address>
        <city>Kortrijk</city>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karin Stellamans</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>U.Z. Leuven - Campus Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>BE 3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-François Daisne</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Site Sainte-Elisabeth-UCL Namur</name>
      <address>
        <city>Namur</city>
        <zip>5000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vincent Remouchamps</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>AZ Turnhout - Campus Sint Elisabeth</name>
      <address>
        <city>Turnhout</city>
        <zip>BE 2300</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katrien Geboers</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>GasthuisZusters Antwerpen - Sint-Augustinus</name>
      <address>
        <city>Wilrijk</city>
        <zip>BE 2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Piet Dirix</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Hradec Kralove</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>CZ 500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Igor Sirak</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinique Pasteur-Lanroze (1174)</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ali Hasbini</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH</name>
      <address>
        <city>Aachen</city>
        <zip>DE 52074</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Eble</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinikum Bayreuth Gmbh</name>
      <address>
        <city>Bayreuth</city>
        <zip>DE 95448</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jochen Willner</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Carl Gustav Carus</name>
      <address>
        <city>Dresden</city>
        <zip>DE 01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fabian Lohaus</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Donato, USL -8</name>
      <address>
        <city>Arezzo</city>
        <zip>IT 52100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simona Borghesi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Careggi</name>
      <address>
        <city>Firenze</city>
        <zip>IT 50134</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lorenzo Livi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale San Raffaele</name>
      <address>
        <city>Milano</city>
        <zip>IT 20132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nadia Gisella Di Muzio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia</name>
      <address>
        <city>Milano</city>
        <zip>IT 20141</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barbara Jereczek-Fossa</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Milan</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marta Scorsetti</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sacro Cuore Hospital</name>
      <address>
        <city>Negrar</city>
        <zip>37024</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Filippo Alongi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Istituti Clinici Scientifici Maugeri</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giovanni Battista Ivaldi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro Nazionale di Adroterapia Oncoloica par il trattamento dei tumori</name>
      <address>
        <city>Pavia</city>
        <zip>IT 27100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ester Orlandi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario Campus Bio-Medico- Oncology Center</name>
      <address>
        <city>Roma</city>
        <zip>IT 00128</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sara Ramella</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universita Di Torino</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Umberto Ricardi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Stichting Catharina Ziekenhuis</name>
      <address>
        <city>Eindhoven</city>
        <zip>NL 5623</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heike Peulen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Radboudumc - Radboud University Medical Center Nijmegen</name>
      <address>
        <city>Nijmegen</city>
        <zip>6525</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Petra Braam</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Radiotherapiegroep Arnhem</name>
      <address>
        <city>Nijmegen</city>
        <zip>NL 6525 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Petra Braam</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Institute Of Oncology</name>
      <address>
        <city>Ljubljana</city>
        <zip>SI 1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ivica Ratosa</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)</name>
      <address>
        <city>Badalona</city>
        <zip>ES 08916</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Josep Jove i Teixido</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron -Vall d'Hebron Institut Oncologia</name>
      <address>
        <city>Barcelona</city>
        <zip>ES 08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sergi Benavente</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital De La Santa Creu I Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>ES 08041</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gemma Sancho-Pardo</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Santa Lucia</name>
      <address>
        <city>Cartagena</city>
        <zip>ES 30202</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan Salinas Ramos</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofia</name>
      <address>
        <city>Cordoba</city>
        <zip>ES 14004</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amalia Palacios Eito</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de La Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>ES 28006</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pablo Castro</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>ES 28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Miren Gaztanaga</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Navarra</name>
      <address>
        <city>Pamplona</city>
        <zip>ES 31008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mikel Rico</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Salamanca (430)</name>
      <address>
        <city>Salamanca</city>
        <zip>ES 37007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luis Perez-Romasanta</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>ES 46026</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jose Antonio Conde Moreno</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Inselspital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hossein Hemmatazad</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie</name>
      <address>
        <city>Geneve</city>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Zilli</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Reseau Hospitalier Neuchatelois - RHNe - La Chaux de Fonds</name>
      <address>
        <city>La Chaux-de-Fonds</city>
        <zip>CH 2303</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olalla Santa Cruz</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital du Valais - Hopital de Sion</name>
      <address>
        <city>Sion</city>
        <zip>1951</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kaouthar Khanfir</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>UniversitaetsSpital Zurich</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthias Guckenberger</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>NHS Grampian - Aberdeen Royal Infirmary</name>
      <address>
        <city>Aberdeen</city>
        <zip>AB25 2ZD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adnan Shaukat</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Christie NHS Foundation trust - The Christie NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Corinne Faivre-Finn</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2SJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthew Hatton</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Slovenia</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>April 21, 2023</last_update_submitted>
  <last_update_submitted_qc>April 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03818503
org study id: EORTC-1811
nct id: NCT03818503
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary objective is the collection of real-world data of cancer patients treated with
      radiotherapy, to support radiotherapy research and to provide evidence of the role of
      radiation oncology in a multidisciplinary approach. This is an open ended prospective
      non-interventional non-therapeutic multi-cohort study.
observational model: Cohort
time perspective: Prospective
measure: Number of patients treated with radiotherapy enrolled in the program
time frame: 5 years
measure: Disease free survival
time frame: 5 years
measure: Loco-regional control
time frame: 5 years
measure: Distant metastasis free survival
time frame: 5 years
measure: Overall survival
time frame: 5 years
measure: Incidence of adverse events related to radiotherapy
time frame: 5 years
arm group label: OligoCare
description: Patients with oligometastatic disease treated with radical radiotherapy
arm group label: ReCare
description: Patients treated with high-dose Re-irradiation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
last name: EORTC HQ
phone: +32 2 774 1611
email: 1811@eortc.org
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country: Austria
country: Belgium
country: Czechia
country: France
country: Germany
country: Italy
country: Netherlands
country: Slovenia
country: Spain
country: Switzerland
country: United Kingdom
responsible party type: Sponsor
sharing ipd: Undecided