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/NCT05991102</url>
    </required_header>
    <id_info>
      <org_study_id>Live-RF</org_study_id>
      <nct_id>NCT05991102</nct_id>
    </id_info>
    <brief_title>Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) in Refractory Metastatic Colorectal Cancer</brief_title>
    <acronym>Live-RF</acronym>
    <official_title>Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) in Refractory Metastatic Colorectal Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Charite University, Berlin, Germany</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Charite University, Berlin, Germany</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Combined chemotherapy and radiofrequency electromagnetic field treatment for patients with&#xD;
        liver dominant refractory metastatic colorectal cancer&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Charité Universitätsmedizin Berlin is currently the only German University Hospital with an&#xD;
        available capacitive radiofrequency electromagnetic field treatment device. While there is&#xD;
        only data available regarding the low toxicity profile of radiofrequency electromagnetic&#xD;
        field treatment for various regions of the body including the abdomen there is no data&#xD;
        available on the combined effect of TAS-102 and radiofrequency electromagnetic field&#xD;
        treatment. The investigators aim to conduct a feasibility trial and plan to compare the&#xD;
        results with data of a prospective trial with a comparable patient population. In addition,&#xD;
        the patients enrolled in this trial will be compared to historic data from patients who&#xD;
        underwent treatment with TAS-102 in this setting (RECOURSE trial).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 21, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">May 31, 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>Overall response rate (ORR)</measure>
      <time_frame>Through study completion, an average of 3 months</time_frame>
      <description>(≥ partial response)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PFS</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Progression-free survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>OS</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Overall survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>QoL</measure>
      <time_frame>During 3 years of trial conduction</time_frame>
      <description>European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>QoL</measure>
      <time_frame>During 3 years of trial conduction</time_frame>
      <description>European Organisation for Research and Treatment of Cancer (EORTC) QLQ-LMC21</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety and depression</measure>
      <time_frame>During 3 years of trial conduction</time_frame>
      <description>Hospital Anxiety and Depression Scale (HADS-D)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acute and late toxicity</measure>
      <time_frame>During 3 years of trial conduction</time_frame>
      <description>CTCAE version 5</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Refractory Metastatic Colorectal Cancer</condition>
    <arm_group>
      <arm_group_label>TAS-102 and radiofrequency electromagnetic field treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Each treatment cycle with TAS-102 will be 28 days in duration. TAS-102 treatment should be continued until progression or unacceptable toxicity.&#xD;
  Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily&#xD;
  Days 6 through 7: Recovery&#xD;
  Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily&#xD;
  Days 13 through 28: Recovery Radiofrequency electromagnetic field treatment using the EHY-2030 device starts within the first week of TAS-102 and should be performed and continued 2 times weekly (60 min each) until progression or the occurrence of unacceptable toxicity. The interval between radiofrequency electromagnetic field treatments treatments should be at least 48h. A modulated electric field with a carrier radiofrequency 13.56 MHz will be generated.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Radiofrequency electromagnetic field treatment</intervention_name>
      <description>Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz</description>
      <arm_group_label>TAS-102 and radiofrequency electromagnetic field treatment</arm_group_label>
      <other_name>mEHT</other_name>
      <other_name>capacitive hyperthermia</other_name>
      <other_name>electrohyperthermia</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Written informed consent prior to any study procedure&#xD;
  &#xD;
            -  18 years or older&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
  &#xD;
            -  Histologically confirmed colorectal cancer&#xD;
  &#xD;
            -  Liver metastasis&#xD;
  &#xD;
            -  Patients received at least two prior regimens of standard chemotherapies and the&#xD;
               patient is refractory to or failing these therapies or is unsuitable for the&#xD;
               treatment.Standard chemotherapy includes fluoropyrimidine, oxaliplatin,&#xD;
               irinotecan,bevacizumab and for patients with KRAS wild-type tumors at least one&#xD;
               anti-EGFR monoclonal antibody of cetuximab/panitumumab. Patients with BRAF mutant&#xD;
               tumors: BRAF inhibitor, MSI-H patients: Checkpoint-inhibition&#xD;
  &#xD;
            -  Knowledge of KRAS status (i.e. wild-type or mutant)&#xD;
  &#xD;
            -  Adequate bone-marrow, liver and renal function:&#xD;
  &#xD;
                 1. Hemoglobin value of ≥9.0 g/dL.&#xD;
  &#xD;
                 2. Absolute neutrophil count of ≥1,500/mm3&#xD;
  &#xD;
                 3. Platelet count ≥100,000/mm3 (IU: ≥100 × 109/L).&#xD;
  &#xD;
                 4. Total serum bilirubin of ≤1.5 mg/dL&#xD;
  &#xD;
                 5. Aspartate aminotransferase and alanine aminotransferase&#xD;
  &#xD;
                    ≤3.0 × upper limit of normal (ULN); if liver function abnormalities are due to&#xD;
                    underlying Liver metastasis, AST and ALT ≤5 × ULN.&#xD;
  &#xD;
                 6. Serum creatinine of ≤1.5 mg/dL.&#xD;
  &#xD;
            -  Patient is able to take medications orally&#xD;
  &#xD;
            -  Women of childbearing potential with negative pregnancy test and agreement for&#xD;
               adequate birth control if conception is possible&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Significant extrahepatic metastasis&#xD;
  &#xD;
            -  Previous treatment with TAS 102&#xD;
  &#xD;
            -  Serious illness other than colorectal cancer or serious medical condition:&#xD;
  &#xD;
                 1. Other concurrently active malignancies excluding malignancies that are disease&#xD;
                    free for more than 5 years or carcinoma-in-situ deemed cured by adequate&#xD;
                    treatment.&#xD;
  &#xD;
                 2. Known brain metastasis or leptomeningeal metastasis.&#xD;
  &#xD;
                 3. Active infection (ie, body temperature ≥38°C due to infection).&#xD;
  &#xD;
                 4. Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks&#xD;
  &#xD;
                 5. Intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or&#xD;
                    cerebrovascular disorder&#xD;
  &#xD;
                 6. Uncontrolled diabetes.&#xD;
  &#xD;
                 7. Myocardial infarction within the last 12 months, severe/unstable angina,&#xD;
                    symptomatic congestive heart failure New York Heart Association (NYHA III/IV)&#xD;
  &#xD;
                 8. Gastrointestinal hemorrhage.&#xD;
  &#xD;
                 9. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome&#xD;
                    (AIDS)-related illness, or hepatitis B or C.&#xD;
  &#xD;
                10. Patients with autoimmune disorders or history of organ transplantation who&#xD;
                    require immunosuppressive therapy.&#xD;
  &#xD;
                11. Psychiatric disease that may increase the risk associated with study&#xD;
                    participation or study drug administration, or may interfere with the&#xD;
                    interpretation of study results.&#xD;
  &#xD;
            -  Radiofrequency treatment technically not possible (e.g. larger metal implants)&#xD;
  &#xD;
            -  Cardiac pacemakers/ICD&#xD;
  &#xD;
            -  Patient not able for supine positioning (e.g. due to pain)&#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_contact>
      <last_name>Pirus Ghadjar, Prof. Dr.</last_name>
      <phone>+49 30 450 527318</phone>
      <email>pirus.ghadjar@charite.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Marcus Beck, Dr.</last_name>
      <phone>+49 30 450 527318</phone>
      <email>marcus.beck@charite.de</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Charité Universitätsmedizin Berlin</name>
        <address>
          <city>Berlin</city>
          <zip>13353</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yvonne Saewe</last_name>
        <phone>+49 30 450 527318</phone>
        <email>yvonne.saewe@charite.de</email>
      </contact>
      <investigator>
        <last_name>Pirus Ghadjar, Prof. Dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sebastian Stintzing, Prof. Dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Marcus Beck, Dr.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Alexander Hansch, Dr.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
      <investigator_full_name>Pirus Ghadjar</investigator_full_name>
      <investigator_title>Prof. Dr.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05991102
  org study id: Live-RF
  nct id: NCT05991102
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Combined chemotherapy and radiofrequency electromagnetic field treatment for patients with
        liver dominant refractory metastatic colorectal cancer
  Charité Universitätsmedizin Berlin is currently the only German University Hospital with an
        available capacitive radiofrequency electromagnetic field treatment device. While there is
        only data available regarding the low toxicity profile of radiofrequency electromagnetic
        field treatment for various regions of the body including the abdomen there is no data
        available on the combined effect of TAS-102 and radiofrequency electromagnetic field
        treatment. The investigators aim to conduct a feasibility trial and plan to compare the
        results with data of a prospective trial with a comparable patient population. In addition,
        the patients enrolled in this trial will be compared to historic data from patients who
        underwent treatment with TAS-102 in this setting (RECOURSE trial).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Overall response rate (ORR)
  time frame: Through study completion, an average of 3 months
  description: (≥ partial response)
  measure: PFS
  time frame: Through study completion, an average of 6 months
  description: Progression-free survival
  measure: OS
  time frame: Through study completion, an average of 1 year
  description: Overall survival
  measure: QoL
  time frame: During 3 years of trial conduction
  description: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
  measure: QoL
  time frame: During 3 years of trial conduction
  description: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-LMC21
  measure: Anxiety and depression
  time frame: During 3 years of trial conduction
  description: Hospital Anxiety and Depression Scale (HADS-D)
  measure: Acute and late toxicity
  time frame: During 3 years of trial conduction
  description: CTCAE version 5
  arm group label: TAS-102 and radiofrequency electromagnetic field treatment
  arm group type: Experimental
  description: Each treatment cycle with TAS-102 will be 28 days in duration. TAS-102 treatment should be continued until progression or unacceptable toxicity.
  Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily
  Days 6 through 7: Recovery
  Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily
  Days 13 through 28: Recovery Radiofrequency electromagnetic field treatment using the EHY-2030 device starts within the first week of TAS-102 and should be performed and continued 2 times weekly (60 min each) until progression or the occurrence of unacceptable toxicity. The interval between radiofrequency electromagnetic field treatments treatments should be at least 48h. A modulated electric field with a carrier radiofrequency 13.56 MHz will be generated.
  intervention type: Device
  intervention name: Radiofrequency electromagnetic field treatment
  description: Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz
  arm group label: TAS-102 and radiofrequency electromagnetic field treatment
  other name: mEHT
  other name: capacitive hyperthermia
  other name: electrohyperthermia
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Pirus Ghadjar, Prof. Dr.
  phone: +49 30 450 527318
  email: pirus.ghadjar@charite.de
  last name: Marcus Beck, Dr.
  phone: +49 30 450 527318
  email: marcus.beck@charite.de
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Germany
  responsible party type: Principal Investigator
  investigator affiliation: Charite University, Berlin, Germany
  investigator full name: Pirus Ghadjar
  investigator title: Prof. Dr.
  mesh term: Colorectal Neoplasms
  sharing ipd: Undecided