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/NCT05996367</url>
    </required_header>
    <id_info>
      <org_study_id>NP 465/23</org_study_id>
      <nct_id>NCT05996367</nct_id>
    </id_info>
    <brief_title>Prospective Cohort of Single-dose Radiotherapy for Painful Bone Lesions in Multiple Myeloma</brief_title>
    <official_title>Prospective Cohort Assessing the Impact of Single-dose Radiotherapy in the Treatment of Painful Bone Lesions in Patients With Multiple Myeloma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Instituto do Cancer do Estado de São Paulo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Instituto do Cancer do Estado de São Paulo</source>
    <oversight_info>
      <has_dmc>No</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>
        Multiple myeloma is a plasma cell neoplasm that can cause painful bone lesions. The main&#xD;
        treatment for these lesions and pain control is radiotherapy, usually in daily fractions. In&#xD;
        2017, a phase III study proved the effectiveness of using a single dose of 8 Gy, but without&#xD;
        description of several important oncological outcomes. This is a single-arm prospective&#xD;
        cohort study. This study aims to describe these outcomes, including retreatment rate and bone&#xD;
        events. Also, as secondary objectives, describe the quality of life and use of analgesic&#xD;
        medications in this population.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 31, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2029</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Retreatment rate at 6 months</measure>
      <time_frame>6 months after radiotherapy</time_frame>
      <description>Percentage of patients that needed a second corse of radiation for painful bone lesions</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Local control</measure>
      <time_frame>6 months and 12 months</time_frame>
      <description>Local control by Recist 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival</measure>
      <time_frame>12 months</time_frame>
      <description>Progression-free survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>12 months</time_frame>
      <description>Overall survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bone event-free survival</measure>
      <time_frame>6 months</time_frame>
      <description>by description from Raje et al. The Lancet 2018</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain relief by the numerical rating pain scale</measure>
      <time_frame>1, 3, 6 and 12 months</time_frame>
      <description>reduction on opioid and single analgesics intake and altered value in the rating pain scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain flair incidence</measure>
      <time_frame>1, 3, 6 and 12 months</time_frame>
      <description>Enhanced pain by at least 2 levels at the numerical rating pain scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life by EORCT QLQ-C30</measure>
      <time_frame>1, 6 and 12 months</time_frame>
      <description>Quality of life by EORCT QLQ-C30 questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life by EORCT QLQ-C30 and MY-24</measure>
      <time_frame>1, 6 and 12 months</time_frame>
      <description>Quality of life by EORCT MY-24 myeloma complementary questionnaires</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Multiple Myeloma</condition>
    <arm_group>
      <arm_group_label>Single Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single-dose radiation to involved-site</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Single-dose involved-site radiotherapy</intervention_name>
      <description>Single-dose of 8 Gy at involved-site radiotherapy</description>
      <arm_group_label>Single Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Biopsy of plasma cell neoplasm with bone lesion treatable with radiotherapy;&#xD;
  &#xD;
            -  Age between 18 and 85 years old;&#xD;
  &#xD;
            -  Performance on the ECOG scale less than or equal to 2.&#xD;
  &#xD;
            -  Not using systemic therapies for 4 weeks OR being on maintenance therapy with the same&#xD;
               drug for at least 4 weeks before radiotherapy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusing to sign or inability to understand the consent term;&#xD;
  &#xD;
            -  Pain less than 2/10 on the numeric pain rating scale;&#xD;
  &#xD;
            -  Change in systemic treatment scheme, including use of bone metabolism modulation&#xD;
               drugs, up to 4 weeks before radiotherapy treatment;&#xD;
  &#xD;
            -  Technical incapacity for the treatment, including, but not limited to, weight greater&#xD;
               than 115Kg, inability to abduct the limb to be treated in appendicular bones,&#xD;
               intolerable pain to remain in the treatment position;&#xD;
  &#xD;
            -  Previous cancer and previous oncological treatments;&#xD;
  &#xD;
            -  Previous autoimmune diseases, even if controlled;&#xD;
  &#xD;
            -  Current pregnancy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Geovanne P Mauro, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Sao Paulo</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Geovanne P Mauro, PhD</last_name>
      <phone>+551126617058</phone>
      <email>geovanne.mauro@hc.fm.usp.br</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Sao Paulo</name>
        <address>
          <city>São Paulo</city>
          <state>Sao Paulo</state>
          <zip>05403-010</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Geovanne Mauro, PhD</last_name>
        <phone>+551126617058</phone>
        <email>geovanne.mauro@hc.fm.usp.br</email>
      </contact>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Instituto do Cancer do Estado de São Paulo</investigator_affiliation>
      <investigator_full_name>Geovanne Pedro Mauro</investigator_full_name>
      <investigator_title>Primary Investigator</investigator_title>
    </responsible_party>
    <keyword>Multiple myeloma</keyword>
    <keyword>Palliative care</keyword>
    <keyword>Radiotherapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Myeloma</mesh_term>
      <mesh_term>Neoplasms, Plasma Cell</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/NCT05996367
  org study id: NP 465/23
  nct id: NCT05996367
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Multiple myeloma is a plasma cell neoplasm that can cause painful bone lesions. The main
        treatment for these lesions and pain control is radiotherapy, usually in daily fractions. In
        2017, a phase III study proved the effectiveness of using a single dose of 8 Gy, but without
        description of several important oncological outcomes. This is a single-arm prospective
        cohort study. This study aims to describe these outcomes, including retreatment rate and bone
        events. Also, as secondary objectives, describe the quality of life and use of analgesic
        medications in this population.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Retreatment rate at 6 months
  time frame: 6 months after radiotherapy
  description: Percentage of patients that needed a second corse of radiation for painful bone lesions
  measure: Local control
  time frame: 6 months and 12 months
  description: Local control by Recist 1.1
  measure: Progression-free survival
  time frame: 12 months
  description: Progression-free survival
  measure: Overall survival
  time frame: 12 months
  description: Overall survival
  measure: Bone event-free survival
  time frame: 6 months
  description: by description from Raje et al. The Lancet 2018
  measure: Pain relief by the numerical rating pain scale
  time frame: 1, 3, 6 and 12 months
  description: reduction on opioid and single analgesics intake and altered value in the rating pain scale
  measure: Pain flair incidence
  time frame: 1, 3, 6 and 12 months
  description: Enhanced pain by at least 2 levels at the numerical rating pain scale
  measure: Quality of life by EORCT QLQ-C30
  time frame: 1, 6 and 12 months
  description: Quality of life by EORCT QLQ-C30 questionnaire
  measure: Quality of life by EORCT QLQ-C30 and MY-24
  time frame: 1, 6 and 12 months
  description: Quality of life by EORCT MY-24 myeloma complementary questionnaires
  arm group label: Single Arm
  arm group type: Experimental
  description: Single-dose radiation to involved-site
  intervention type: Radiation
  intervention name: Single-dose involved-site radiotherapy
  description: Single-dose of 8 Gy at involved-site radiotherapy
  arm group label: Single Arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Geovanne P Mauro, PhD
  role: Principal Investigator
  affiliation: University of Sao Paulo
  last name: Geovanne P Mauro, PhD
  phone: +551126617058
  email: geovanne.mauro@hc.fm.usp.br
  facility: 
  status: Recruiting
  contact: 
  country: Brazil
  responsible party type: Principal Investigator
  investigator affiliation: Instituto do Cancer do Estado de São Paulo
  investigator full name: Geovanne Pedro Mauro
  investigator title: Primary Investigator
  mesh term: Multiple Myeloma
  mesh term: Neoplasms, Plasma Cell
  sharing ipd: No