<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/NCT03024138</url>
  </required_header>
  <id_info>
    <org_study_id>RT 2016-02; REACT</org_study_id>
    <nct_id>NCT03024138</nct_id>
  </id_info>
  <brief_title>Repeat CT for Evaluation of Inter- and Intrafraction Changes During Curative Thoracic Radiotherapy</brief_title>
  <acronym>REACT</acronym>
  <official_title>Repeat CT for Evaluation of Inter- and Intrafraction Changes During Curative Thoracic Radiotherapy; An Exploratory Pilot Study (REACT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Center Groningen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Radiotherapy (combined with chemotherapy) is increasingly applied in the curative treatment&#xD;
      of tumours located in the thoracic region (esophageal cancer, lung cancer, breast cancer, and&#xD;
      (non) Hodgkin lymphoma). Accurate radiotherapy planning and delivery is essential for the&#xD;
      treatment to be effective. However, this accuracy is compromised by tumour and organ motion.&#xD;
      Radiotherapy treatment planning is typically performed on a planning-CT scan recorded several&#xD;
      days prior to commencement of radiotherapy. Inter-fraction set up variations and organ motion&#xD;
      during treatment can lead to differences between the calculated dose distribution on the&#xD;
      planning-CT and the radiation dose actually received by the tumour and normal organs.&#xD;
      Accurate assessment of these effects is essential to determine optimal margins in order to&#xD;
      irradiate the tumour adequately while minimizing the dose to the organs at risk (OARs).&#xD;
&#xD;
      In the near future, patients with esophageal cancer, lung cancer, breast cancer and (non)&#xD;
      Hodgkin lymphoma are excellent candidates for proton beam therapy (PBT), which enables marked&#xD;
      reductions of the radiation dose to the OARs and thus decreasing the risk of radiation&#xD;
      induced cardiac and lung toxicity. However, for PBT using pencil beam scanning (PBS),&#xD;
      knowledge of tumour and organ motion will be even more important. The potential major&#xD;
      advantages of PBS for tumours in the thoracic region are challenged by the respiratory motion&#xD;
      of the tumour, breast, esophagus, diaphragm, heart, stomach, and lungs. Setup errors and&#xD;
      inter- and intra-fraction organ motion cause geometric displacement of the tumours and normal&#xD;
      tissues, which can cause underdosage of the target volumes and overdosage of the organs at&#xD;
      risk. Furthermore, it can result in changes in tissue densities in the beam path, which can&#xD;
      alter the position of the Bragg peaks and lead to distorted dose distributions. If pencil&#xD;
      beam scanning techniques are used to treat moving tumours, there is interplay between the&#xD;
      dynamic pencil beam delivery and target motion. This phenomenon can cause additional&#xD;
      deterioration of the delivered dose distribution, usually manifesting as significant local&#xD;
      under and/or over dosage. It is therefore essential to incorporate motion-related&#xD;
      uncertainties during treatment planning.&#xD;
&#xD;
      The main objective of this study is to evaluate the impact of inter-fraction tumour and organ&#xD;
      motion - while taking into account intra-fraction movements appropriately - on photon and&#xD;
      proton radiotherapy treatment planning in order to yield robust intensity modulated photon&#xD;
      and/or proton treatment plans.&#xD;
&#xD;
      Objective: To evaluate the impact of inter-fraction tumour and organ geometrical dislocation&#xD;
      for moving tumours on photon and proton radiotherapy treatment plans in order to create&#xD;
      robust intensity modulated photon- and/or proton treatment plans.&#xD;
&#xD;
      Study design: Pilot-study (80 patients).&#xD;
&#xD;
      Study population: Patients with esophageal cancer (EC), (non) small cell lung cancer&#xD;
      ((N)SCLC) stage III, breast cancer, or (non) Hodgkin lymphoma who will be treated with&#xD;
      radiotherapy (with or without chemotherapy) with curative intent.&#xD;
&#xD;
      Intervention (if applicable): Not applicable.&#xD;
&#xD;
      Main study parameters/endpoints: Robustness parameters (homogeneity index; coverage of&#xD;
      clinical target volume), dose to organs at risk (OARs), such as the heart (mean heart dose,&#xD;
      MHD) and the lungs (mean lung dose, MLD).&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness: During the radiotherapy treatment course, patients will undergo weekly repeat&#xD;
      planning CT scans in treatment position without contrast agents in order to evaluate the&#xD;
      impact of inter-fraction tumour and organ motion.&#xD;
&#xD;
      Furthermore, additional CBCTs are collected after 10 radiotherapy fractions to assess the&#xD;
      intra-fraction motion.&#xD;
&#xD;
      The additional radiation dose of these 3-6 4D-CT's and 10 CBCTs is low (4-6 x 25-30mSv + 10 x&#xD;
      7mSv results in an effective dose &lt; 250mSv) compared to the therapeutic radiation dose&#xD;
      (40-60Gy). The risks are therefore negligible and the burden is low.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Changes in dose volume histogram (DVH) parameters (in Gy or volume %) during weekly evaluation of the intra- and inter fraction motion.</measure>
    <time_frame>3-6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intrafraction variation in tumour position and organ motion during 3-6 weeks of radiotherapy</measure>
    <time_frame>3-6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interfraction variation in tumour position and organ motion during 3-6 weeks of radiotherapy</measure>
    <time_frame>3-6 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Thoracic Tumor</condition>
  <arm_group>
    <arm_group_label>Repeat CT</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Repeat CT scan</intervention_name>
    <arm_group_label>Repeat CT</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        1. Patients with esophageal cancer (adeno and squamous cell carcinoma), who will be&#xD;
             treated with radiotherapy with curative intent, with or without chemotherapy (followed&#xD;
             by surgery).&#xD;
&#xD;
          2. Patients with non-small-cell lung cancer (NSCLC) of any histological subtype, and&#xD;
             small-cell lung cancer (SCLC) stage III, who will be treated with radiotherapy with&#xD;
             curative intent in combination with chemotherapy.&#xD;
&#xD;
          3. Patients with breast cancer of any histological subtype, who will be treated with&#xD;
             radiotherapy with curative intent.&#xD;
&#xD;
          4. Patients with (non) Hodgkin lymphoma undergoing thoracic radiotherapy in a curative&#xD;
             treatment setting.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven esophageal cancer, stage III NSCLC or SCLC, breast cancer, or&#xD;
             (non) Hodgkin lymphoma.&#xD;
&#xD;
          -  Scheduled for external-beam photon radiotherapy to the thoracic region with curative&#xD;
             intention&#xD;
&#xD;
          -  Scheduled for (neo-)adjuvant or primary (chemo)radiotherapy&#xD;
&#xD;
          -  WHO 0-2.&#xD;
&#xD;
          -  Age &gt;= 18 years&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Relative contra-indications, such as pain, for lying on the treatment or CT couch&#xD;
&#xD;
          -  Non compliance with any of the inclusion criteria.&#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_contact>
    <last_name>Lotte Kors, MSc</last_name>
    <phone>+31 503617244</phone>
    <email>l.w.kors@umcg.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>UMCG</name>
      <address>
        <city>Groningen</city>
        <zip>9713GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lotte Kors, MSc</last_name>
      <phone>+31 503617244</phone>
      <email>l.w.kors@umcg.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>February 28, 2018</last_update_submitted>
  <last_update_submitted_qc>February 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>C.T. Muijs</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thoracic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03024138
org study id: RT 2016-02; REACT
nct id: NCT03024138
lead sponsor: 
has dmc: Yes
Radiotherapy (combined with chemotherapy) is increasingly applied in the curative treatment
      of tumours located in the thoracic region (esophageal cancer, lung cancer, breast cancer, and
      (non) Hodgkin lymphoma). Accurate radiotherapy planning and delivery is essential for the
      treatment to be effective. However, this accuracy is compromised by tumour and organ motion.
      Radiotherapy treatment planning is typically performed on a planning-CT scan recorded several
      days prior to commencement of radiotherapy. Inter-fraction set up variations and organ motion
      during treatment can lead to differences between the calculated dose distribution on the
      planning-CT and the radiation dose actually received by the tumour and normal organs.
      Accurate assessment of these effects is essential to determine optimal margins in order to
      irradiate the tumour adequately while minimizing the dose to the organs at risk (OARs).

      In the near future, patients with esophageal cancer, lung cancer, breast cancer and (non)
      Hodgkin lymphoma are excellent candidates for proton beam therapy (PBT), which enables marked
      reductions of the radiation dose to the OARs and thus decreasing the risk of radiation
      induced cardiac and lung toxicity. However, for PBT using pencil beam scanning (PBS),
      knowledge of tumour and organ motion will be even more important. The potential major
      advantages of PBS for tumours in the thoracic region are challenged by the respiratory motion
      of the tumour, breast, esophagus, diaphragm, heart, stomach, and lungs. Setup errors and
      inter- and intra-fraction organ motion cause geometric displacement of the tumours and normal
      tissues, which can cause underdosage of the target volumes and overdosage of the organs at
      risk. Furthermore, it can result in changes in tissue densities in the beam path, which can
      alter the position of the Bragg peaks and lead to distorted dose distributions. If pencil
      beam scanning techniques are used to treat moving tumours, there is interplay between the
      dynamic pencil beam delivery and target motion. This phenomenon can cause additional
      deterioration of the delivered dose distribution, usually manifesting as significant local
      under and/or over dosage. It is therefore essential to incorporate motion-related
      uncertainties during treatment planning.

      The main objective of this study is to evaluate the impact of inter-fraction tumour and organ
      motion - while taking into account intra-fraction movements appropriately - on photon and
      proton radiotherapy treatment planning in order to yield robust intensity modulated photon
      and/or proton treatment plans.

      Objective: To evaluate the impact of inter-fraction tumour and organ geometrical dislocation
      for moving tumours on photon and proton radiotherapy treatment plans in order to create
      robust intensity modulated photon- and/or proton treatment plans.

      Study design: Pilot-study (80 patients).

      Study population: Patients with esophageal cancer (EC), (non) small cell lung cancer
      ((N)SCLC) stage III, breast cancer, or (non) Hodgkin lymphoma who will be treated with
      radiotherapy (with or without chemotherapy) with curative intent.

      Intervention (if applicable): Not applicable.

      Main study parameters/endpoints: Robustness parameters (homogeneity index; coverage of
      clinical target volume), dose to organs at risk (OARs), such as the heart (mean heart dose,
      MHD) and the lungs (mean lung dose, MLD).

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: During the radiotherapy treatment course, patients will undergo weekly repeat
      planning CT scans in treatment position without contrast agents in order to evaluate the
      impact of inter-fraction tumour and organ motion.

      Furthermore, additional CBCTs are collected after 10 radiotherapy fractions to assess the
      intra-fraction motion.

      The additional radiation dose of these 3-6 4D-CT's and 10 CBCTs is low (4-6 x 25-30mSv + 10 x
      7mSv results in an effective dose < 250mSv) compared to the therapeutic radiation dose
      (40-60Gy). The risks are therefore negligible and the burden is low.
observational model: Cohort
time perspective: Prospective
measure: Changes in dose volume histogram (DVH) parameters (in Gy or volume %) during weekly evaluation of the intra- and inter fraction motion.
time frame: 3-6 weeks
measure: Intrafraction variation in tumour position and organ motion during 3-6 weeks of radiotherapy
time frame: 3-6 weeks
measure: Interfraction variation in tumour position and organ motion during 3-6 weeks of radiotherapy
time frame: 3-6 weeks
arm group label: Repeat CT
intervention type: Radiation
intervention name: Repeat CT scan
arm group label: Repeat CT
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lotte Kors, MSc
phone: +31 503617244
email: l.w.kors@umcg.nl
facility: 
status: Recruiting
contact: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: C.T. Muijs
investigator title: Principal investigator
mesh term: Thoracic Neoplasms
sharing ipd: No