<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/NCT04424732</url>
  </required_header>
  <id_info>
    <org_study_id>20 KHCC 91</org_study_id>
    <nct_id>NCT04424732</nct_id>
  </id_info>
  <brief_title>SBRT for Breast Cancer Oligometastases</brief_title>
  <official_title>Stereotactic Body Radiotherapy for Bone Only Oligometastatic Breast Cancer: A Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Hussein Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Hussein Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective data collection of treatment outcome for newly diagnosed&#xD;
      oligometastatic breast cancers with 1-3 bone metastases. Eligible patients will be identified&#xD;
      from the weekly Breast MDC. Patients will receive the recommended systemic and local&#xD;
      treatment (including metastases directed SBRT) according to our clinical practice&#xD;
      guidelines.Patients will be followed according to our routine with clinical and radiologic&#xD;
      assessment. It is preferred that the same imaging method that was used to originally detect&#xD;
      the metastases be used in follow-up assessments. The first imaging for SBRT sites will be&#xD;
      three months post SBRT and every three months for the first year, every 6 months for the&#xD;
      second year, then annually. Response and progression for these metastases will be evaluated&#xD;
      using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version&#xD;
      1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions is&#xD;
      used in the RECIST criteria. If functional imaging (bone scan, PET) were used at staging,&#xD;
      changes in the uptake will be used in follow up scans to determine response to treatment and&#xD;
      progression. As for SBRT related morbidities, we will use the Common Terminology Criteria for&#xD;
      Adverse Events (CTCAE v5) for toxicity reporting and scoring.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2023</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>Progression free survival (PFS)</measure>
    <time_frame>5 years</time_frame>
    <description>the interval from diagnosis until disease progression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>5 years</time_frame>
    <description>time from diagnosis to death from any cause or last follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Existing metastasis control</measure>
    <time_frame>3 years</time_frame>
    <description>the interval from diagnosis until local progression of the treated metastases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appearance of new metastases</measure>
    <time_frame>3 years</time_frame>
    <description>the interval from diagnosis until appearance of new metastases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>3 years</time_frame>
    <description>CTCAE v5. for acute and chronic toxicity reporting and scoring</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Breast Neoplasm Malignant Female</condition>
  <arm_group>
    <arm_group_label>Stereotactic Body Radiotherapy for Breast Bony oligometastases</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Newly diagnosed bone only oligometastatic breast cancers with 1-3 bone metastases will be enrolled in this protocol. Patients will receive SBRT to all metastatic sites.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic Body Radiotherapy</intervention_name>
    <description>This is a prospective study of breast bone only oligometastases (up to three sites). Following systemic treatment and primary tumor control, patients will receive SBRT to all metastatic sites. Data on toxicities and oncological outcomes will be collected for future analysis. There will be no change in the standard systemic therapy nor the local therapy of the primary tumor.</description>
    <arm_group_label>Stereotactic Body Radiotherapy for Breast Bony oligometastases</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women &gt;18 years old with a pathologically proven breast cancer who present with 1-3&#xD;
             bone metastases will be included.&#xD;
&#xD;
          -  Metastases need to be confirmed pathologically if possible, otherwise two different&#xD;
             imaging modalities (CTor MRI and bone scan or PET) are needed to confirm metastases.&#xD;
&#xD;
          -  Patients should be able to receive the recommended local and systemic treatment and&#xD;
             the primary tumor must be controlled at time of SBRT.&#xD;
&#xD;
          -  Maximum diameter of individual metastasis metastasis in any dimension ≤ 5 cm; and must&#xD;
             be &gt;5 cm away from each other (defined as Edge to Edge of tumor).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non bone metastatic breast cancers&#xD;
&#xD;
          -  Prior history of radiotherapy to same sites of SBRT&#xD;
&#xD;
          -  Pathologic fractures of involved bones&#xD;
&#xD;
          -  Contraindications to radiotherapy including pregnancy and connective tissue disease.&#xD;
&#xD;
          -  Patients with impaired cognitive functions.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abdulmajeed Dayyat, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>King Hussein Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Abdulmajeed H Dayyat, MD</last_name>
    <phone>0096265300460</phone>
    <phone_ext>1860</phone_ext>
    <email>adayyat@khcc.jo</email>
  </overall_contact>
  <location>
    <facility>
      <name>King Hussein Cancer Center</name>
      <address>
        <city>Amman</city>
        <zip>11941</zip>
        <country>Jordan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Farah Zahran</last_name>
      <phone>0096265300460</phone>
      <phone_ext>1346</phone_ext>
      <email>FZahran@KHCC.JO</email>
    </contact>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Hussein Cancer Center</investigator_affiliation>
    <investigator_full_name>Abdulmajeed Dayyat</investigator_full_name>
    <investigator_title>Consultant Radiation Oncologist</investigator_title>
  </responsible_party>
  <keyword>Stereotactic Body Radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT04424732
org study id: 20 KHCC 91
nct id: NCT04424732
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a prospective data collection of treatment outcome for newly diagnosed
      oligometastatic breast cancers with 1-3 bone metastases. Eligible patients will be identified
      from the weekly Breast MDC. Patients will receive the recommended systemic and local
      treatment (including metastases directed SBRT) according to our clinical practice
      guidelines.Patients will be followed according to our routine with clinical and radiologic
      assessment. It is preferred that the same imaging method that was used to originally detect
      the metastases be used in follow-up assessments. The first imaging for SBRT sites will be
      three months post SBRT and every three months for the first year, every 6 months for the
      second year, then annually. Response and progression for these metastases will be evaluated
      using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version
      1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions is
      used in the RECIST criteria. If functional imaging (bone scan, PET) were used at staging,
      changes in the uptake will be used in follow up scans to determine response to treatment and
      progression. As for SBRT related morbidities, we will use the Common Terminology Criteria for
      Adverse Events (CTCAE v5) for toxicity reporting and scoring.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free survival (PFS)
time frame: 5 years
description: the interval from diagnosis until disease progression
measure: Overall survival (OS)
time frame: 5 years
description: time from diagnosis to death from any cause or last follow-up
measure: Existing metastasis control
time frame: 3 years
description: the interval from diagnosis until local progression of the treated metastases
measure: Appearance of new metastases
time frame: 3 years
description: the interval from diagnosis until appearance of new metastases
measure: Adverse Events
time frame: 3 years
description: CTCAE v5. for acute and chronic toxicity reporting and scoring
arm group label: Stereotactic Body Radiotherapy for Breast Bony oligometastases
arm group type: Other
description: Newly diagnosed bone only oligometastatic breast cancers with 1-3 bone metastases will be enrolled in this protocol. Patients will receive SBRT to all metastatic sites.
intervention type: Radiation
intervention name: Stereotactic Body Radiotherapy
description: This is a prospective study of breast bone only oligometastases (up to three sites). Following systemic treatment and primary tumor control, patients will receive SBRT to all metastatic sites. Data on toxicities and oncological outcomes will be collected for future analysis. There will be no change in the standard systemic therapy nor the local therapy of the primary tumor.
arm group label: Stereotactic Body Radiotherapy for Breast Bony oligometastases
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Abdulmajeed Dayyat, MD
role: Principal Investigator
affiliation: King Hussein Cancer Center
last name: Abdulmajeed H Dayyat, MD
phone: 0096265300460
phone ext: 1860
email: adayyat@khcc.jo
facility: 
status: Recruiting
contact: 
country: Jordan
responsible party type: Principal Investigator
investigator affiliation: King Hussein Cancer Center
investigator full name: Abdulmajeed Dayyat
investigator title: Consultant Radiation Oncologist
mesh term: Breast Neoplasms
mesh term: Neoplasms