xml: <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/NCT06029218</url>
    </required_header>
    <id_info>
      <org_study_id>2022/72</org_study_id>
      <nct_id>NCT06029218</nct_id>
    </id_info>
    <brief_title>Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy</brief_title>
    <acronym>P1V2</acronym>
    <official_title>Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy : Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Antoine Lacassagne</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Antoine Lacassagne</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>
        Thanks to the intrinsic qualities of the proton beam, proton therapy will reduce adverse&#xD;
        effects of irradiation. The Proteus®One is the latest generation of proton therapy equipment,&#xD;
        enabling the Centre Antoine Lacassagne to expand its range of treatments by carrying out new&#xD;
        proton therapy treatments. It has an innovative compact isocentric rotating head (Gantry)&#xD;
        that allows the radiation beam to be directed at different angles around the patient. In some&#xD;
        cases, two beams are used to treat tumours, and by convention, both beams are delivered&#xD;
        during the same session. However, it is necessary to position the patient before each beam,&#xD;
        which is time-consuming because 2 beams have to be positioned very precisely each day. The&#xD;
        aim of this study is therefore to assess the toxicity of proton therapy delivered by a single&#xD;
        daily beam compared with proton therapy delivered by two daily beams, which is the&#xD;
        conventional technique.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 13, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2031</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To evaluate the frequency of occurrence of toxicities in the group of patients treated with two daily beams (2DB) and in the group of patients treated with one daily beams (1DB).</measure>
      <time_frame>During 2 to 7 weeks of protontherapy treatment and during 5 years follow-up</time_frame>
      <description>Assessment of the incidence of grade ≥2 medical device-related toxicities assessed according to CTCAE version 5.0 in each of the two treatment arms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Determining the effectiveness of proton therapy</measure>
      <time_frame>5-year follow-up visits</time_frame>
      <description>Efficacy will be assessed in terms of relapse rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determining the effectiveness of proton therapy</measure>
      <time_frame>5-year follow-up visits</time_frame>
      <description>Efficacy will be assessed in terms of local control by MRI assessment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determining the effectiveness of proton therapy</measure>
      <time_frame>5 years follow-up</time_frame>
      <description>Efficacy will be assessed in terms of overall survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life assessment</measure>
      <time_frame>During 2-7 weeks of protontherapy treatment and during 5 years follow-up</time_frame>
      <description>Quality of life will be assessed using the EORTC QLQ-C30 scale (Appendix 2), version 3 at the inclusion assessment, at the end-of-treatment visit and at each assessment visit for five years. Version 3.0 of the QLQ-C30 has four-point scales for the items 1 to 28 namely : 1 : &quot;Not a tall&quot;, 2 : &quot;A little&quot;, 3 : &quot;Quite a bit&quot; and 4 : &quot;Very much.&quot; Higher score mean worse outcome. Item 29 and 30 has seven-point scales from 1 : &quot; very bad &quot; to 7 &quot;Excellent&quot;. Lower score mean worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the time saving between the two arms 1DB and 2DB</measure>
      <time_frame>2-7 weeks of protontherapy treatment</time_frame>
      <description>Time savings will be assessed by measuring the time taken for door-to-door proton therapy treatment sessions.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">106</enrollment>
    <condition>Chordoma</condition>
    <condition>Chondrosarcoma</condition>
    <condition>Ewing Sarcoma</condition>
    <condition>Osteosarcoma</condition>
    <arm_group>
      <arm_group_label>1DB</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>One daily Beam treatment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>2DB</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Two daily beam goldstandard</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Proteus ONE one daily beam</intervention_name>
      <description>A single daily beam is used, doubling the dose delivered for this treatment incidence.</description>
      <arm_group_label>1DB</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Proteus ONE two daily beam</intervention_name>
      <description>two daily beams are used, in accordance with the initial treatment plan and the patient's standard of care</description>
      <arm_group_label>2DB</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Chordoma, chondrosarcoma of the skull base and spine, Ewing's sarcoma, and&#xD;
               osteosarcoma meeting the criteria for treatment by proton therapy&#xD;
  &#xD;
            -  Tumour requiring 2 beams&#xD;
  &#xD;
            -  MRI less than one month old&#xD;
  &#xD;
            -  PS 0-2.&#xD;
  &#xD;
            -  Patient who has read the patient information note and signed the consent form.&#xD;
  &#xD;
            -  Patient with healthcare insurance cover.&#xD;
  &#xD;
            -  Age over 18 years.&#xD;
  &#xD;
            -  For women of childbearing age, negative urine pregnancy test and effective&#xD;
               contraception in place for the duration of treatment and for six months following the&#xD;
               end of treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Persons deprived of their liberty or under guardianship.&#xD;
  &#xD;
            -  Unable to undergo the medical follow-up of the clinical investigation for&#xD;
               geographical, social or psychological reasons.&#xD;
  &#xD;
            -  Patient eligible for symptom reduction surgery Vulnerable populations and participants&#xD;
               defined in Articles 64 to 68 of Regulation (EU) 2017/745 of the European Parliament&#xD;
               and of the Council of 5 April 2017.&#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>Clement DEVIC, PhD</last_name>
      <phone>0033492031511</phone>
      <email>clement.devic@nice.unicancer.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Centre Antoine lacassagne</name>
        <address>
          <city>Nice</city>
          <zip>06000</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>BONDIAU Pierre Yves</last_name>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>protontherapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteosarcoma</mesh_term>
      <mesh_term>Sarcoma, Ewing</mesh_term>
      <mesh_term>Chondrosarcoma</mesh_term>
      <mesh_term>Chordoma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029218
  org study id: 2022/72
  nct id: NCT06029218
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Thanks to the intrinsic qualities of the proton beam, proton therapy will reduce adverse
        effects of irradiation. The Proteus®One is the latest generation of proton therapy equipment,
        enabling the Centre Antoine Lacassagne to expand its range of treatments by carrying out new
        proton therapy treatments. It has an innovative compact isocentric rotating head (Gantry)
        that allows the radiation beam to be directed at different angles around the patient. In some
        cases, two beams are used to treat tumours, and by convention, both beams are delivered
        during the same session. However, it is necessary to position the patient before each beam,
        which is time-consuming because 2 beams have to be positioned very precisely each day. The
        aim of this study is therefore to assess the toxicity of proton therapy delivered by a single
        daily beam compared with proton therapy delivered by two daily beams, which is the
        conventional technique.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: To evaluate the frequency of occurrence of toxicities in the group of patients treated with two daily beams (2DB) and in the group of patients treated with one daily beams (1DB).
  time frame: During 2 to 7 weeks of protontherapy treatment and during 5 years follow-up
  description: Assessment of the incidence of grade ≥2 medical device-related toxicities assessed according to CTCAE version 5.0 in each of the two treatment arms.
  measure: Determining the effectiveness of proton therapy
  time frame: 5-year follow-up visits
  description: Efficacy will be assessed in terms of relapse rate
  measure: Determining the effectiveness of proton therapy
  time frame: 5-year follow-up visits
  description: Efficacy will be assessed in terms of local control by MRI assessment
  measure: Determining the effectiveness of proton therapy
  time frame: 5 years follow-up
  description: Efficacy will be assessed in terms of overall survival
  measure: Quality of life assessment
  time frame: During 2-7 weeks of protontherapy treatment and during 5 years follow-up
  description: Quality of life will be assessed using the EORTC QLQ-C30 scale (Appendix 2), version 3 at the inclusion assessment, at the end-of-treatment visit and at each assessment visit for five years. Version 3.0 of the QLQ-C30 has four-point scales for the items 1 to 28 namely : 1 : "Not a tall", 2 : "A little", 3 : "Quite a bit" and 4 : "Very much." Higher score mean worse outcome. Item 29 and 30 has seven-point scales from 1 : " very bad " to 7 "Excellent". Lower score mean worse outcome.
  measure: Evaluate the time saving between the two arms 1DB and 2DB
  time frame: 2-7 weeks of protontherapy treatment
  description: Time savings will be assessed by measuring the time taken for door-to-door proton therapy treatment sessions.
  arm group label: 1DB
  arm group type: Experimental
  description: One daily Beam treatment
  arm group label: 2DB
  arm group type: Active Comparator
  description: Two daily beam goldstandard
  intervention type: Radiation
  intervention name: Proteus ONE one daily beam
  description: A single daily beam is used, doubling the dose delivered for this treatment incidence.
  arm group label: 1DB
  intervention type: Radiation
  intervention name: Proteus ONE two daily beam
  description: two daily beams are used, in accordance with the initial treatment plan and the patient's standard of care
  arm group label: 2DB
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Clement DEVIC, PhD
  phone: 0033492031511
  email: clement.devic@nice.unicancer.fr
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Osteosarcoma
  mesh term: Sarcoma, Ewing
  mesh term: Chondrosarcoma
  mesh term: Chordoma
  sharing ipd: No