<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/NCT03022539</url>
  </required_header>
  <id_info>
    <org_study_id>RT2016-01; RACE</org_study_id>
    <nct_id>NCT03022539</nct_id>
  </id_info>
  <brief_title>Repeat CT Scans for Evaluation of Inter- and Intrafraction Motion and it's Effect on Radiotherapy Dose Distribution During Curative Radiotherapy for Pelvic Tumours</brief_title>
  <acronym>RACE</acronym>
  <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 commonly used in the curative treatment of&#xD;
      pelvic tumours, such as in cervical, vulvar and anal cancer. In these patients, cure rates&#xD;
      are high but may be associated with significant treatment-related toxicities, especially&#xD;
      dermatologic, gastrointestinal, genitourinary and hematologic toxicity.&#xD;
&#xD;
      Accurate treatment planning and dose delivery is essential for radiotherapy in order to be&#xD;
      effective in terms of local tumour control and to reduce radiation-induced side effects.&#xD;
      However, accuracy is challenged by tumour and organ motion from fraction to fraction&#xD;
      (interfraction movements). At present, radiotherapy treatment planning is typically performed&#xD;
      on one planning-CT scan which is performed before the start of the treatment. However,&#xD;
      interfraction set up variations and organ motions can lead to differences between the&#xD;
      calculated dose distribution on the planning-CT and the radiation dose actually received by&#xD;
      the tumour and normal organs (actual given dose). Current photon radiotherapy of the pelvic&#xD;
      area is relatively insensitive to these changes and margins from CTV to PTV ensures an&#xD;
      adequate dose coverage of the tumour area. Despite newer techniques in photon therapy, like&#xD;
      intensity modulated radiotherapy (IMRT), critical organs still receive a substantial amount&#xD;
      of dose leading to clinically relevant acute and late side effects. With proton beam therapy,&#xD;
      the amount of radiation dose to the organs at risk can be significantly reduced.&#xD;
&#xD;
      For proton beam therapy (PBT) however, knowledge of tumour and organ motion will be more&#xD;
      important. The major potential advantages of PBT for tumours in the pelvic area in terms of&#xD;
      prevention of radiation-induced side effects are challenged by differences in bladder volume,&#xD;
      rectal filling and air gaps especially in the small bowel, sigmoid and rectum. Setup errors&#xD;
      and organ motion cause geometric displacement of the tumours and normal tissues, which&#xD;
      deteriorates the dose gradients from target volume to normal tissue. Furthermore, it can&#xD;
      result in changes in tissue densities in the beam path, which can alter the position of the&#xD;
      Bragg peaks, in turn leading to distorted dose distributions, usually manifesting as&#xD;
      significant local under and/or over dosage.&#xD;
&#xD;
      In this study, the investigators want to evaluate the impact of inter and intrafractional&#xD;
      tumour and organ motion on photon and proton radiotherapy treatment planning in order to&#xD;
      create robust intensity modulated photon- and/or proton treatment plans (IMRT, IMPT) with the&#xD;
      final aim to lower treatment related toxicity.&#xD;
&#xD;
      Objective: To explore the extent of inter- and intrafraction anatomical changes of the tumour&#xD;
      and surrounding normal tissues, throughout the full course of treatment, and to subsequently&#xD;
      assess the impact of these changes on the nominal planned dose. This information is required&#xD;
      to design robust treatment plans (photon and/or proton) that will ensure optimal local tumour&#xD;
      control while reducing toxicity.&#xD;
&#xD;
      Study design: Pilot-study (40 patients).&#xD;
&#xD;
      Study population: Patients with cervical, vulvar or anal cancer, who are planned for&#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 small bowel, rectum,&#xD;
      bladder and bone marrow.&#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 without contrast agents in order to evaluate the impact of intra and&#xD;
      inter-fraction tumour and organ motion.&#xD;
&#xD;
      The additional radiation dose of these 5 extra CT's is relatively low (5 x 8 mSv, plus 1 x 22&#xD;
      mSv for the 4D CT scan) in relation to the therapeutic radiation dose (50.4-85 Gy). The risks&#xD;
      are therefore negligible and the burden is low.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">August 2, 2021</completion_date>
  <primary_completion_date type="Actual">August 2, 2021</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>CTV dose coverage on repeat CT scans</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Pelvic Tumor</condition>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Repeat CT scan</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        1. Patients with cervical cancer, who will be treated with radiotherapy with or without&#xD;
             chemotherapy, with curative intent (10 patients after Wertheim Meigs surgery and 10&#xD;
             patients without surgery)&#xD;
&#xD;
          2. Patients with vulvar or anal cancer who will be treated with radiotherapy with&#xD;
             curative intent in combination with or without chemotherapy (10 patients with vulvar&#xD;
             cancer and 10 patients with anal cancer)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven anal, vulvar or cervical cancer&#xD;
&#xD;
          -  Scheduled for external-beam photon radiotherapy with curative intention&#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>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>October 20, 2021</last_update_submitted>
  <last_update_submitted_qc>October 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>Jannet C.Beukema</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pelvic 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/NCT03022539
org study id: RT2016-01; RACE
nct id: NCT03022539
lead sponsor: 
has dmc: Yes
Radiotherapy (combined with chemotherapy) is commonly used in the curative treatment of
      pelvic tumours, such as in cervical, vulvar and anal cancer. In these patients, cure rates
      are high but may be associated with significant treatment-related toxicities, especially
      dermatologic, gastrointestinal, genitourinary and hematologic toxicity.

      Accurate treatment planning and dose delivery is essential for radiotherapy in order to be
      effective in terms of local tumour control and to reduce radiation-induced side effects.
      However, accuracy is challenged by tumour and organ motion from fraction to fraction
      (interfraction movements). At present, radiotherapy treatment planning is typically performed
      on one planning-CT scan which is performed before the start of the treatment. However,
      interfraction set up variations and organ motions 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 (actual given dose). Current photon radiotherapy of the pelvic
      area is relatively insensitive to these changes and margins from CTV to PTV ensures an
      adequate dose coverage of the tumour area. Despite newer techniques in photon therapy, like
      intensity modulated radiotherapy (IMRT), critical organs still receive a substantial amount
      of dose leading to clinically relevant acute and late side effects. With proton beam therapy,
      the amount of radiation dose to the organs at risk can be significantly reduced.

      For proton beam therapy (PBT) however, knowledge of tumour and organ motion will be more
      important. The major potential advantages of PBT for tumours in the pelvic area in terms of
      prevention of radiation-induced side effects are challenged by differences in bladder volume,
      rectal filling and air gaps especially in the small bowel, sigmoid and rectum. Setup errors
      and organ motion cause geometric displacement of the tumours and normal tissues, which
      deteriorates the dose gradients from target volume to normal tissue. Furthermore, it can
      result in changes in tissue densities in the beam path, which can alter the position of the
      Bragg peaks, in turn leading to distorted dose distributions, usually manifesting as
      significant local under and/or over dosage.

      In this study, the investigators want to evaluate the impact of inter and intrafractional
      tumour and organ motion on photon and proton radiotherapy treatment planning in order to
      create robust intensity modulated photon- and/or proton treatment plans (IMRT, IMPT) with the
      final aim to lower treatment related toxicity.

      Objective: To explore the extent of inter- and intrafraction anatomical changes of the tumour
      and surrounding normal tissues, throughout the full course of treatment, and to subsequently
      assess the impact of these changes on the nominal planned dose. This information is required
      to design robust treatment plans (photon and/or proton) that will ensure optimal local tumour
      control while reducing toxicity.

      Study design: Pilot-study (40 patients).

      Study population: Patients with cervical, vulvar or anal cancer, who are planned for
      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 small bowel, rectum,
      bladder and bone marrow.

      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 without contrast agents in order to evaluate the impact of intra and
      inter-fraction tumour and organ motion.

      The additional radiation dose of these 5 extra CT's is relatively low (5 x 8 mSv, plus 1 x 22
      mSv for the 4D CT scan) in relation to the therapeutic radiation dose (50.4-85 Gy). The risks
      are therefore negligible and the burden is low.
observational model: Cohort
time perspective: Prospective
measure: CTV dose coverage on repeat CT scans
time frame: 1 year
intervention type: Radiation
intervention name: Repeat CT scan
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: Jannet C.Beukema
investigator title: MD
mesh term: Pelvic Neoplasms
sharing ipd: No