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/NCT05998993</url>
    </required_header>
    <id_info>
      <org_study_id>CTIC001</org_study_id>
      <nct_id>NCT05998993</nct_id>
    </id_info>
    <brief_title>Study to Evaluate SBRT for EGFR Mutant NSCLC Patients Receiving Osimertinib (CULTRO)</brief_title>
    <acronym>CULTRO</acronym>
    <official_title>Phase II Study to Evaluate the Efficacy and Safety of SBRT as an Adjunctive Intervention for Oligoresidual Disease in EGFR Mutant NSCLC With First-Line Osimertinib Treatment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo</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>
        Phase II Study to Evaluate the Impact of SBRT (Stereotactic Body Radiation Therapy) and/or&#xD;
        SRS (Stereotactic Radiosurgery) on Oligoresidual Disease in EGFR Mutation Patients Treated&#xD;
        with Osimertinib as First-Line Systemic Intervention. All candidates must exhibit a partial&#xD;
        response after 12 weeks of treatment with the third-generation tyrosine kinase inhibitor&#xD;
        (alone or in combination with chemotherapy) and a maximum of five (5) residual lesions in a&#xD;
        maximum of two (2) organs. The primary outcome will be progression-free survival (PFS), and&#xD;
        secondary outcomes will include overall survival (OS), proportion of patients without&#xD;
        progression at months 12 and 36, safety, and overall response rate (ORR). Additionally, an&#xD;
        exploratory analysis will be conducted on the prognostic value of liquid biopsy&#xD;
        (supplementary information), considering baseline presence of mutations (determined by Next&#xD;
        Generation Sequencing tests) and reduction or negativization of allelic fraction (AF).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Phase II study with a single-stage Fleming design based on a normal approximation to the&#xD;
        binomial distribution, with a one-sided type I error of 10% and a power of 90% to detect 30&#xD;
        events related to disease progression. Under the alternative hypothesis to detect a 35%&#xD;
        improvement in PFS, 35 patients are required to be recruited over 22 months, with a minimum&#xD;
        median follow-up of 14 months. An interim analysis will be conducted to determine early&#xD;
        termination of the study using a Lan-DeMets monitoring boundary and an O'Brien-Fleming&#xD;
        stopping rule. The interim analysis will be performed when 20 out of the expected 30 events&#xD;
        have been observed. Employing the O'Brien-Fleming statistic, the critical value for the&#xD;
        Z-score in the interim analysis (to stop and reject the null hypothesis) will be 1.054, and&#xD;
        the critical value for the Z-score to stop and reject the alternative (futility) will be&#xD;
        -0.204.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">November 2028</completion_date>
    <primary_completion_date type="Anticipated">November 2026</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</measure>
      <time_frame>Month 12</time_frame>
      <description>Time from the initiation of systemic treatment (Osimertinib) to disease progression or death. This outcome is not influenced by second-line interventions and allows for the estimation of the relative efficacy of the treatment and its Hazard Ratio (HR)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall Response Rate (ORR)</measure>
      <time_frame>Month 12</time_frame>
      <description>Proportion of patients with partial or complete response following the implementation of SBRT. This measurement does not include stable disease</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS)</measure>
      <time_frame>Month 12</time_frame>
      <description>Time from diagnosis, the first day of systemic treatment, and implementation of SBRT to death from any cause or last follow-up</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-Free Time (PFT)</measure>
      <time_frame>Month 12</time_frame>
      <description>Time from the execution of SBRT to objective tumor progression, excluding death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse Events and Safety</measure>
      <time_frame>Month 12</time_frame>
      <description>Adverse events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5 from the National Cancer Institute (NCI) US</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">35</enrollment>
    <condition>EGF-R Positive Non-Small Cell Lung Cancer</condition>
    <condition>Non Small Cell Lung Cancer</condition>
    <condition>EGFR Exon 19 Deletion</condition>
    <condition>EGFR Exon 21 Mutation</condition>
    <condition>EGFR G719X</condition>
    <arm_group>
      <arm_group_label>Radiation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A total of 35 patients diagnosed and treated at CTIC Centro de Tratamiento e Investigación Sobre Cáncer Luis Carlos Sarmiento Angulo.</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Stereotactic Body Radiation Therapy SBRT</intervention_name>
      <description>This is a non-randomized Phase II study in which all patients receive the experimental treatment with Stereotactic Ablative Radiotherapy (SABR) to residual tumor lesions (up to 5 residual metastatic lesions in a maximum of 2 organs) following 12 weeks of systemic treatment with Osimertinib. The study aims to enroll 35 patients diagnosed and treated at CTIC Centro de Tratamiento e Investigación Sobre Cáncer Luis Carlos Sarmiento Angulo.</description>
      <arm_group_label>Radiation</arm_group_label>
      <other_name>Stereotactic radiosurgery SRS</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be older than 18 years of age.&#xD;
  &#xD;
            -  Be capable of giving informed consent to participate in the study.&#xD;
  &#xD;
            -  Have histological confirmation compatible with EGFR mutant non-small cell lung cancer&#xD;
               (NSCLC) and metastatic disease (with or without histological confirmation of&#xD;
               metastatic lesions).&#xD;
  &#xD;
            -  Have confirmation of the presence of common EGFR mutations (exon 19 deletion,&#xD;
               L858R/exon 21, or G719X) through any locally and internationally accepted standard&#xD;
               tests.&#xD;
  &#xD;
            -  Have received at least 12 weeks of Osimertinib treatment (with or without the addition&#xD;
               of chemotherapy based on FLAURA2 study results after discussion with the investigative&#xD;
               team).&#xD;
  &#xD;
            -  Have a partial response defined by RECIST 1.1 criteria.&#xD;
  &#xD;
            -  Have a maximum of 5 residual tumor lesions in up to 2 organs suitable for treatment&#xD;
               with Stereotactic Ablative Radiotherapy (SABR).&#xD;
  &#xD;
            -  Have the following imaging and clinical tests within 4 weeks before study entry:&#xD;
  &#xD;
            -  Contrast-enhanced brain MRI.&#xD;
  &#xD;
            -  Chest/abdomen/pelvis CT scan, with or without bone scan (at the investigator's&#xD;
               discretion) if PET-CT was not performed.&#xD;
  &#xD;
            -  18-FDG PET-CT.&#xD;
  &#xD;
            -  Spinal MRI for patients with vertebral or paravertebral metastases.&#xD;
  &#xD;
            -  Electrocardiogram (EKG) and transthoracic echocardiogram.&#xD;
  &#xD;
            -  Complete blood count and standard blood chemistry.&#xD;
  &#xD;
            -  Negative pregnancy test for fertile women within 4 weeks prior to starting&#xD;
               radiotherapy.&#xD;
  &#xD;
            -  Liquid biopsy for assessment of tumor allelic fraction (baseline).&#xD;
  &#xD;
            -  ECOG performance status 0-2.&#xD;
  &#xD;
            -  All sites of oligoresidual disease must be safely treatable according to the following&#xD;
               criteria:&#xD;
  &#xD;
            -  All brain lesions must be treatable with SRS.&#xD;
  &#xD;
            -  The maximum size for extracranial lesions will be up to 6 cm, with exceptions for bone&#xD;
               metastases which may include lesions larger than 6 cm at the discretion of the&#xD;
               investigative medical team (e.g., ribs, scapula, or pelvis).&#xD;
  &#xD;
            -  Life expectancy &gt;6 months.&#xD;
  &#xD;
            -  Not eligible for surgical treatment.&#xD;
  &#xD;
            -  Osimertinib treatment must be suspended 48 hours before the start of ablative therapy&#xD;
               and cannot be initiated within 48 hours of receiving the last fraction. In patients&#xD;
               receiving SBRT for central lung lesions, the suspension time for Osimertinib may be&#xD;
               extended up to 5 days before and after ablative therapy.&#xD;
  &#xD;
            -  Patients may have previously received treatments such as radiofrequency or microwave&#xD;
               ablation for oligoresidual lesions, but imaging must demonstrate that the lesion&#xD;
               persists and is treatable with SABR.&#xD;
  &#xD;
            -  Metastatic tumor lesions that received initial treatment with radiosurgery cannot be&#xD;
               included for SABR treatment.&#xD;
  &#xD;
            -  If initial treatment was conventional radiotherapy, SABR could be considered if safe&#xD;
               to administer. In this case, the ablative therapy must be discussed by the&#xD;
               investigative team.&#xD;
  &#xD;
            -  The eligibility and prognosis criteria will be reviewed by the multidisciplinary&#xD;
               thoracic tumor board at CTIC Centro de Tratamiento e Investigación Sobre Cáncer Luis&#xD;
               Carlos Sarmiento Angulo.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe comorbidities contraindicating radiation therapy.&#xD;
  &#xD;
            -  Bone metastases in the femur with a high risk of fracture.&#xD;
  &#xD;
            -  Complete response to Osimertinib treatment (no oligoresidual disease for ablative&#xD;
               treatment).&#xD;
  &#xD;
            -  Inability to treat all oligoresidual lesions with ablative intent.&#xD;
  &#xD;
            -  History of pneumonitis or functionally limiting interstitial lung disease. It may be&#xD;
               considered limiting if the patient is unable to perform DLCO maneuvers or if adjusted&#xD;
               DLCO is less than 35% of predicted, PaO2 at Bogotá altitude with FiO2 21% is less than&#xD;
               or equal to 50 mmHg.&#xD;
  &#xD;
            -  Clinical or radiological evidence of symptomatic spinal cord compression.&#xD;
  &#xD;
            -  Dominant brain metastatic disease requiring surgical management (e.g., imminent&#xD;
               herniation or hydrocephalus).&#xD;
  &#xD;
            -  Candidate for a clinical trial with an experimental drug.&#xD;
  &#xD;
            -  Inability to receive Osimertinib with minimal adherence.&#xD;
  &#xD;
            -  Oligoresidual involvement in peritoneum, pleura, or bone marrow (non-measurable&#xD;
               disease).&#xD;
  &#xD;
            -  Leptomeningeal involvement (presumed based on imaging findings or confirmed by&#xD;
               cerebrospinal fluid cytology).&#xD;
  &#xD;
            -  Pregnant or breastfeeding women.&#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>Luis Rojas, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Liliana Gutiérrez, RN</last_name>
      <phone>3003768158</phone>
      <email>lgutierrez@fctic.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Briegel De Las Salas, Microb</last_name>
      <phone>3044921963</phone>
      <email>bcalderon@fctic.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CTIC - Centro de Tratamiento e Investigación Sobre Cáncer Luis Carlos Sarmiento Angulo</name>
        <address>
          <city>Bogotá</city>
          <country>Colombia</country>
        </address>
      </facility>
      <contact>
        <last_name>Liliana Gutiérrez, RN</last_name>
        <phone>573003768158</phone>
        <email>lgutierrez@fctic.org</email>
      </contact>
      <contact_backup>
        <last_name>Briegel De Las Salas, Microb</last_name>
        <phone>573044921963</phone>
        <email>bcalderon@fctic.org</email>
      </contact_backup>
      <investigator>
        <last_name>Luis Rojas, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Andrés Cardona, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Iván Bobadilla, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jairo Zuluaga, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Alejandro González, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Lucía Viola, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Stella Martínez, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Colombia</country>
    </location_countries>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>Yes</sharing_ipd>
      <ipd_description>The current study is intended to be published, even if prematurely terminated. The publication may encompass all or part of the following variations: online publication of a synopsis, abstract and/or presentation at a scientific conference, or publication of a complete scientific article.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>5 years</ipd_time_frame>
      <ipd_access_criteria>Email to PI</ipd_access_criteria>
    </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/NCT05998993
  org study id: CTIC001
  nct id: NCT05998993
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Phase II Study to Evaluate the Impact of SBRT (Stereotactic Body Radiation Therapy) and/or
        SRS (Stereotactic Radiosurgery) on Oligoresidual Disease in EGFR Mutation Patients Treated
        with Osimertinib as First-Line Systemic Intervention. All candidates must exhibit a partial
        response after 12 weeks of treatment with the third-generation tyrosine kinase inhibitor
        (alone or in combination with chemotherapy) and a maximum of five (5) residual lesions in a
        maximum of two (2) organs. The primary outcome will be progression-free survival (PFS), and
        secondary outcomes will include overall survival (OS), proportion of patients without
        progression at months 12 and 36, safety, and overall response rate (ORR). Additionally, an
        exploratory analysis will be conducted on the prognostic value of liquid biopsy
        (supplementary information), considering baseline presence of mutations (determined by Next
        Generation Sequencing tests) and reduction or negativization of allelic fraction (AF).
  Phase II study with a single-stage Fleming design based on a normal approximation to the
        binomial distribution, with a one-sided type I error of 10% and a power of 90% to detect 30
        events related to disease progression. Under the alternative hypothesis to detect a 35%
        improvement in PFS, 35 patients are required to be recruited over 22 months, with a minimum
        median follow-up of 14 months. An interim analysis will be conducted to determine early
        termination of the study using a Lan-DeMets monitoring boundary and an O'Brien-Fleming
        stopping rule. The interim analysis will be performed when 20 out of the expected 30 events
        have been observed. Employing the O'Brien-Fleming statistic, the critical value for the
        Z-score in the interim analysis (to stop and reject the null hypothesis) will be 1.054, and
        the critical value for the Z-score to stop and reject the alternative (futility) will be
        -0.204.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Progression-Free Survival
  time frame: Month 12
  description: Time from the initiation of systemic treatment (Osimertinib) to disease progression or death. This outcome is not influenced by second-line interventions and allows for the estimation of the relative efficacy of the treatment and its Hazard Ratio (HR)
  measure: Overall Response Rate (ORR)
  time frame: Month 12
  description: Proportion of patients with partial or complete response following the implementation of SBRT. This measurement does not include stable disease
  measure: Overall Survival (OS)
  time frame: Month 12
  description: Time from diagnosis, the first day of systemic treatment, and implementation of SBRT to death from any cause or last follow-up
  measure: Progression-Free Time (PFT)
  time frame: Month 12
  description: Time from the execution of SBRT to objective tumor progression, excluding death
  measure: Adverse Events and Safety
  time frame: Month 12
  description: Adverse events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5 from the National Cancer Institute (NCI) US
  arm group label: Radiation
  arm group type: Experimental
  description: A total of 35 patients diagnosed and treated at CTIC Centro de Tratamiento e Investigación Sobre Cáncer Luis Carlos Sarmiento Angulo.
  intervention type: Radiation
  intervention name: Stereotactic Body Radiation Therapy SBRT
  description: This is a non-randomized Phase II study in which all patients receive the experimental treatment with Stereotactic Ablative Radiotherapy (SABR) to residual tumor lesions (up to 5 residual metastatic lesions in a maximum of 2 organs) following 12 weeks of systemic treatment with Osimertinib. The study aims to enroll 35 patients diagnosed and treated at CTIC Centro de Tratamiento e Investigación Sobre Cáncer Luis Carlos Sarmiento Angulo.
  arm group label: Radiation
  other name: Stereotactic radiosurgery SRS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Luis Rojas, MD
  role: Principal Investigator
  affiliation: Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
  last name: Liliana Gutiérrez, RN
  phone: 3003768158
  email: lgutierrez@fctic.org
  last name: Briegel De Las Salas, Microb
  phone: 3044921963
  email: bcalderon@fctic.org
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Colombia
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  PMID: 27789196
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  PMID: 33268447
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung
  sharing ipd: Yes
  ipd description: The current study is intended to be published, even if prematurely terminated. The publication may encompass all or part of the following variations: online publication of a synopsis, abstract and/or presentation at a scientific conference, or publication of a complete scientific article.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: 5 years
  ipd access criteria: Email to PI