<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/NCT04407897</url>
  </required_header>
  <id_info>
    <org_study_id>H-19014486</org_study_id>
    <nct_id>NCT04407897</nct_id>
  </id_info>
  <brief_title>SOFT- Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases</brief_title>
  <acronym>SOFT</acronym>
  <official_title>SOFT - A Phase 2 Study of Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Herlev Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Henry Ford Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Herlev Hospital</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>
      The SOFT study will evaluate the feasibility and safety of MR-guided stereotactic ablative&#xD;
      radiotherapy (SABR) for infra-diaphragmatic soft tissue metastases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators wish to evaluate the safety and feasibility of MR-guided stereotactic&#xD;
      radiation to patients with infra-diaphragmatic oligometastatic disease including quality of&#xD;
      life assessments and patient-reported outcome measures. Further, the investigators assess&#xD;
      clinical response among patients with oligometastatic disease (OMD), defined as up to five&#xD;
      metastases in up to three different organs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 7, 2019</start_date>
  <completion_date type="Anticipated">April 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 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>
    <intervention_model_description>This is a prospective investigator-initiated phase II multicentre-study, investigating the toxicity and efficacy of SABR for infra-diaphragmatic tumors.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE).</measure>
    <time_frame>Assessed at 1 year.</time_frame>
    <description>Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Freedom from local progression.</measure>
    <time_frame>Assessed at week 6, 12, 24, 36, and 52.</time_frame>
    <description>Defined as the time from inclusion to local progression as determined by investigator using RECIST 1.1 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival.</measure>
    <time_frame>Assessed at week 6, 12, 24, 36, and 52.</time_frame>
    <description>The time from inclusion until disease progression determined by investigator assessment of objective disease assessment per RECIST 1.1 .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to progression (TTP) outside the radiation field.</measure>
    <time_frame>Assessed at week 6, 12, 24, 36, and 52.</time_frame>
    <description>Defined as the time from inclusion until progression outside the radiation field determined by a CT, MR, or PET-CT per RECIST 1.1. Outside the radiation field is defined as outside and not adjacent to the PTV.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Solid Tumor</condition>
  <condition>Oligometastases</condition>
  <condition>Soft Tissue Disease</condition>
  <arm_group>
    <arm_group_label>Radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with oligometastatic lesions, fulfilling the inclusion/exclusion criteria's will be assigned to SABR.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic radiotherapy</intervention_name>
    <description>Three different dose fractionation schemes will be available: 45 Gy in 3 fractions, 50 Gy in 5 fractions, and 60 Gy in 8 fractions.</description>
    <arm_group_label>Radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histology or cytology proven non-haematological cancer.&#xD;
&#xD;
          -  At least one metastasis should be localized in the infra-diaphragmatic soft tissue.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) scale of performance status ≤ 2.&#xD;
&#xD;
          -  ≥ 18 years old.&#xD;
&#xD;
          -  Life expectancy &gt; 6 months.&#xD;
&#xD;
          -  Target diameter (GTV) ≤ 5 cm.&#xD;
&#xD;
          -  Metastatic lesions must be visible, imaging defined targets and suitable for treatment&#xD;
             with SABR.&#xD;
&#xD;
          -  In case of de novo OMD and oligometastatic recurrence a maximum of 5 targets&#xD;
             (including the primary tumour) in a maximum of 3 organ sites are allowed.&#xD;
&#xD;
          -  In case of oligoprogressive disease (OPD) * and induced OMD ** only 3 metastases&#xD;
             (including the primary tumour) are allowed.&#xD;
&#xD;
          -  All metastatic sites are treated or planned for ablative therapy (including surgery).&#xD;
             For OPD, only the sites in progression is required to fulfil this criterion.&#xD;
&#xD;
          -  A baseline scan within 28 days of inclusion (PET-CT or CT and MR scanning).&#xD;
&#xD;
          -  No curative intended treatment option available.&#xD;
&#xD;
          -  An ablative strategy should be deemed clinically relevant and it is at the discretion&#xD;
             of the treating physician to decide.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
          -  If the target is in the liver, a Child-Pugh Score A is required.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient cannot tolerate physical set up required for SABR.&#xD;
&#xD;
          -  Active bowel obstruction.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness.&#xD;
&#xD;
          -  Medical contraindication to undergoing MR-imaging.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Patients with uncontrolled brain metastases.&#xD;
&#xD;
          -  Uncontrolled disease in respect to malignant pleural effusion, ascites, lymphangitic&#xD;
             carcinomatosis, pleural carcinomatosis or peritoneal carcinomatosis.&#xD;
&#xD;
          -  If the patient has received previous radiotherapy, the combined dose at the radiation&#xD;
             site must not exceed the dose constraints.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mette Felter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helev Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Herlev Hospital</name>
      <address>
        <city>Herlev</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 17, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>April 27, 2022</last_update_submitted>
  <last_update_submitted_qc>April 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Herlev Hospital</investigator_affiliation>
    <investigator_full_name>Mette Felter</investigator_full_name>
    <investigator_title>Principal Investigator, MD, Mette Felter</investigator_title>
  </responsible_party>
  <keyword>SBRT</keyword>
  <keyword>SABR</keyword>
  <keyword>MR-guided radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</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/NCT04407897
org study id: H-19014486
nct id: NCT04407897
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The SOFT study will evaluate the feasibility and safety of MR-guided stereotactic ablative
      radiotherapy (SABR) for infra-diaphragmatic soft tissue metastases.
The investigators wish to evaluate the safety and feasibility of MR-guided stereotactic
      radiation to patients with infra-diaphragmatic oligometastatic disease including quality of
      life assessments and patient-reported outcome measures. Further, the investigators assess
      clinical response among patients with oligometastatic disease (OMD), defined as up to five
      metastases in up to three different organs.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a prospective investigator-initiated phase II multicentre-study, investigating the toxicity and efficacy of SABR for infra-diaphragmatic tumors.
primary purpose: Treatment
masking: None (Open Label)
measure: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE).
time frame: Assessed at 1 year.
description: Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
measure: Freedom from local progression.
time frame: Assessed at week 6, 12, 24, 36, and 52.
description: Defined as the time from inclusion to local progression as determined by investigator using RECIST 1.1 criteria.
measure: Progression free survival.
time frame: Assessed at week 6, 12, 24, 36, and 52.
description: The time from inclusion until disease progression determined by investigator assessment of objective disease assessment per RECIST 1.1 .
measure: Time to progression (TTP) outside the radiation field.
time frame: Assessed at week 6, 12, 24, 36, and 52.
description: Defined as the time from inclusion until progression outside the radiation field determined by a CT, MR, or PET-CT per RECIST 1.1. Outside the radiation field is defined as outside and not adjacent to the PTV.
arm group label: Radiotherapy
arm group type: Experimental
description: Patients with oligometastatic lesions, fulfilling the inclusion/exclusion criteria's will be assigned to SABR.
intervention type: Radiation
intervention name: Stereotactic radiotherapy
description: Three different dose fractionation schemes will be available: 45 Gy in 3 fractions, 50 Gy in 5 fractions, and 60 Gy in 8 fractions.
arm group label: Radiotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Mette Felter, MD
role: Principal Investigator
affiliation: Helev Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Herlev Hospital
investigator full name: Mette Felter
investigator title: Principal Investigator, MD, Mette Felter
mesh term: Neoplasm Metastasis
sharing ipd: No