<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/NCT04405401</url>
  </required_header>
  <id_info>
    <org_study_id>2021-9066</org_study_id>
    <nct_id>NCT04405401</nct_id>
  </id_info>
  <brief_title>Stereotactic Ablative Radiotherapy for Oligo-Progressive Non Small Cell Lung Cancer</brief_title>
  <acronym>SUPPRESS-NSCLC</acronym>
  <official_title>Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Non Small Cell Lung Cancer: A Registry-based Phase II Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre hospitalier de l'Université de Montréal (CHUM)</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>
      A registry-based randomized screening phase II trial. A total of 68 patients with metastatic&#xD;
      non small cell lung cancer on systemic therapy with oligoprogression to 1-5 extracranial&#xD;
      lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic&#xD;
      therapy, best supportive care, continue current systemic line, based on treating physician&#xD;
      decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions&#xD;
      while continuing their current systemic therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 5, 2021</start_date>
  <completion_date type="Anticipated">July 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2023</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Randomized screening phase II trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PFS</measure>
    <time_frame>5 years</time_frame>
    <description>PFS defined from randomization to disease progression at any site or death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OS</measure>
    <time_frame>5 years</time_frame>
    <description>OS defined as time from randomization to time of death from any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)</measure>
    <time_frame>5 years</time_frame>
    <description>Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life 5-level EQ-5D (EQ-5D-5L)</measure>
    <time_frame>5 years</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grade ≥ 3 toxicity</measure>
    <time_frame>5 years</time_frame>
    <description>Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local control</measure>
    <time_frame>5 years</time_frame>
    <description>Defined as time from the end of SABR treatment to date of local failure and will be measured only in the experimental arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to next systemic therapy</measure>
    <time_frame>5 years</time_frame>
    <description>Defined as time from randomization to time of subsequent therapy line</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">68</enrollment>
  <condition>Lung Cancer Metastatic</condition>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Switch to subsequent systemic therapy line, best supportive care or continue current systemic line</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental SABR arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Definitive SABR to oligoprogressive lesions + continue current systemic therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>SABR</intervention_name>
    <description>SABR to all oligoprogressive lesions + continuation of current systemic therapy</description>
    <arm_group_label>Standard of care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>Patients on the standard arm will be treated as per standard of care in our institution. Treatment options could include switching to next systemic therapy line, best supportive care or continuing on current systemic therapy.</description>
    <arm_group_label>Experimental SABR arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Metastatic NSCLC enrolled in our CRCHUM Lung Cancer Registry and co-enrolled to the&#xD;
             PERa registry&#xD;
&#xD;
          -  Ability to provide written informed consent&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-3&#xD;
&#xD;
          -  Oligoprogression to 1-5 extracranial lesions ≤ 5cm and involving ≤ 3 organs.&#xD;
             Progression at the primary tumor site should be counted within the total of 5 lesions.&#xD;
             For patients with lymph node metastases, each node is counted as one site of&#xD;
             metastasis.&#xD;
&#xD;
          -  Oligoprogression while on ICI or TKI (any line)&#xD;
&#xD;
          -  Patients with brain metastasis are allowed; brain metastasis are not counted in the&#xD;
             maximum number of lesions and should be treated as per standard of care&#xD;
&#xD;
          -  All sites of disease can, in the opinion of the investigator, be safely treated and&#xD;
             targetable with SABR (taking into account prior local therapy, organ function and&#xD;
             underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis,&#xD;
             etc.)&#xD;
&#xD;
          -  Patients with prior metastases that have been treated with ablative therapies (e.g.&#xD;
             radiotherapy, surgery or radiofrequency ablation) before their current line of&#xD;
             systemic therapy, are eligible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any lesion beyond 5 cm&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Any medical condition that could, in the opinion of the investigator, preclude&#xD;
             radiotherapy or prevent follow-up after radiotherapy.&#xD;
&#xD;
          -  Presence of spinal cord compression Metastatic disease that invades the GI tract&#xD;
             (including esophagus, stomach, small or large bowel)&#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_official>
    <last_name>Houda Bahig, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Centre hospitalier de l'Université de Montréal (CHUM)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bertrand Routy, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Centre hospitalier de l'Université de Montréal (CHUM)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Silvine Benth</last_name>
    <phone>514-890-8254</phone>
    <email>silvine.benth.chum@ssss.gouv.qc.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Université de Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2X 3E4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diane Trudel</last_name>
      <phone>514-890-8254</phone>
      <email>diane.dt.trudel.chum@ssss.gouv.qc.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>April 24, 2023</last_update_submitted>
  <last_update_submitted_qc>April 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>non small cell lung cancer</keyword>
  <keyword>oligoprogression</keyword>
  <keyword>steretactic body radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04405401
org study id: 2021-9066
nct id: NCT04405401
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A registry-based randomized screening phase II trial. A total of 68 patients with metastatic
      non small cell lung cancer on systemic therapy with oligoprogression to 1-5 extracranial
      lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic
      therapy, best supportive care, continue current systemic line, based on treating physician
      decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions
      while continuing their current systemic therapy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized screening phase II trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: PFS
time frame: 5 years
description: PFS defined from randomization to disease progression at any site or death
measure: OS
time frame: 5 years
description: OS defined as time from randomization to time of death from any cause.
measure: Quality of life Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)
time frame: 5 years
description: Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)
measure: Quality of life 5-level EQ-5D (EQ-5D-5L)
time frame: 5 years
description: questionnaire
measure: Grade ≥ 3 toxicity
time frame: 5 years
description: Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
measure: Local control
time frame: 5 years
description: Defined as time from the end of SABR treatment to date of local failure and will be measured only in the experimental arm
measure: Time to next systemic therapy
time frame: 5 years
description: Defined as time from randomization to time of subsequent therapy line
arm group label: Standard of care
arm group type: Active Comparator
description: Switch to subsequent systemic therapy line, best supportive care or continue current systemic line
arm group label: Experimental SABR arm
arm group type: Experimental
description: Definitive SABR to oligoprogressive lesions + continue current systemic therapy
intervention type: Radiation
intervention name: SABR
description: SABR to all oligoprogressive lesions + continuation of current systemic therapy
arm group label: Standard of care
intervention type: Other
intervention name: Standard of care
description: Patients on the standard arm will be treated as per standard of care in our institution. Treatment options could include switching to next systemic therapy line, best supportive care or continuing on current systemic therapy.
arm group label: Experimental SABR arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Houda Bahig, MD PhD
role: Study Chair
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
last name: Bertrand Routy, MD PhD
role: Study Chair
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
last name: Silvine Benth
phone: 514-890-8254
email: silvine.benth.chum@ssss.gouv.qc.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: Undecided