<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/NCT04473781</url>
  </required_header>
  <id_info>
    <org_study_id>19-001258</org_study_id>
    <secondary_id>NCI-2020-04542</secondary_id>
    <nct_id>NCT04473781</nct_id>
  </id_info>
  <brief_title>Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer</brief_title>
  <official_title>Prospective Study of Interstitial Brachytherapy for Unresectable/Unablatable T1b/T2a Renal Masses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jonsson Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jonsson Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase I/II trial investigates the side effects of interstitial brachytherapy and to see&#xD;
      how well it works in limiting the growth of large kidney cancer masses in patients with&#xD;
      kidney cancer that have refused or are unable to undergo surgery or ablation&#xD;
      (unresectable/unablatable). Brachytherapy, also known as internal radiation therapy,&#xD;
      temporarily introduces a radiation source into or near the tumor to eradicate the tumor&#xD;
      cells. Giving brachytherapy may potentially reduce the size of the kidney cancer mass that&#xD;
      would otherwise not be amenable to surgical management and translate into lower risk of&#xD;
      spread.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the safety and feasibility of renal interstitial radiation therapy&#xD;
      (interstitial brachytherapy). (Safety Lead-In) II. To evaluate local control of renal&#xD;
      interstitial brachytherapy. (Expansion Phase)&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate treatment response of the primary tumor. II. To evaluate 12 month distant&#xD;
      progression free survival. III. To evaluate the 12 month volumetric growth of the primary&#xD;
      tumor mass. IV. To determine biomarkers predicting response and resistance to radiation&#xD;
      treatment.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo interstitial brachytherapy for 1-2 fractions in the absence of disease&#xD;
      progression or unacceptable toxicity. Patients who undergo 2 fractions may receive both&#xD;
      fractions in the same day or on 2 separate days over 2 weeks.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every 3 months for at least 3&#xD;
      years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 16, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Dose limiting toxicity (DLT)</measure>
    <time_frame>From the first administration of study therapy up to 60 days</time_frame>
    <description>A 3+3 safety lead-in phase will be employed in order to determine the DLT for interstitial renal brachytherapy. Grading of DLTs will follow the guidelines provided in the Common Terminology Criteria for Adverse Events version 5.0 criteria.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>One year (12-month) linear growth rate</measure>
    <time_frame>At 1 year</time_frame>
    <description>Adequate local control will be defined as minimal growth kinetics (=&lt; 1 mm/year) on 1 year follow-up.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">17</enrollment>
  <condition>Stage I Renal Cell Cancer</condition>
  <condition>Stage II Renal Cell Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment (interstitial brachytherapy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo interstitial brachytherapy for 1-2 fractions in the absence of disease progression or unacceptable toxicity. Patients who undergo 2 fractions may receive both fractions in the same day or on 2 separate days over 2 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Interstitial Radiation Therapy</intervention_name>
    <description>Undergo interstitial brachytherapy</description>
    <arm_group_label>Treatment (interstitial brachytherapy)</arm_group_label>
    <other_name>BRACHYTHERAPY, INTERSTITIAL</other_name>
    <other_name>Implant Radiation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elected to undergo interstitial brachytherapy as part of conventional treatment for&#xD;
             renal cell carcinoma&#xD;
&#xD;
          -  Biopsy proven renal cell carcinoma&#xD;
&#xD;
          -  No definitive evidence of locally advanced (nodal or tumor thrombus) or distant&#xD;
             (metastatic) disease&#xD;
&#xD;
          -  Lesion size (maximal dimension) of 4 to 10 cm&#xD;
&#xD;
          -  Patient not a candidate for curative surgery (unwilling or unable to pursue surgery)&#xD;
&#xD;
          -  Lesion cannot be reliably treated with ablative techniques&#xD;
&#xD;
          -  Entire lesion able to be treated adequately by brachytherapy per radiation oncologist&#xD;
&#xD;
          -  Tumor predominantly solid (~ &gt; 80%)&#xD;
&#xD;
          -  Lesion that has been observed for &gt;= 6 months with demonstrable growth rate&#xD;
             anticipated to be &gt;= 4 mm/year by same imaging modality&#xD;
&#xD;
          -  Renal tumor that is amenable to percutaneous access for interstitial renal&#xD;
             brachytherapy (Institutional Review Board [IRB])&#xD;
&#xD;
          -  Hemoglobin &gt; 9&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;= 1500/uL (microliter)&#xD;
&#xD;
          -  Platelets &gt;= 100,000/uL&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =&lt; 3.0 upper limit&#xD;
             of normal (ULN)&#xD;
&#xD;
          -  Total bilirubin =&lt; ULN&#xD;
&#xD;
          -  A competent immune system&#xD;
&#xD;
          -  Estimated glomerular filtration rate (eGFR) &gt;= 30&#xD;
&#xD;
          -  Good performance status (Eastern Cooperative Oncology Group [ECOG]) &lt; 2&#xD;
&#xD;
          -  Understanding and willingness to provide consent&#xD;
&#xD;
          -  No prior systemic treatment for kidney cancer&#xD;
&#xD;
          -  Women of childbearing potential must have negative pregnancy test at start of therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of an active, untreated, non-renal malignancy&#xD;
&#xD;
          -  Uncontrolled medical illness including infections, hypertension, arrhythmias, heart&#xD;
             failure, or myocardial infarction within 6 months&#xD;
&#xD;
          -  History of bleeding diathesis or recent bleeding episode&#xD;
&#xD;
          -  Need for urgent treatment of renal cancer due bleeding, pain, or paraneoplastic&#xD;
             syndrome&#xD;
&#xD;
          -  Prior surgery or radiation therapy to the operative site&#xD;
&#xD;
          -  Unwillingness to undergo clinical and laboratory monitoring and/or imaging studies&#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>Albert J Chang</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLA / Jonsson Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA / Jonsson Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bashir Wyatt</last_name>
      <phone>310-794-3448</phone>
      <email>BAWyatt@mednet.ucla.edu</email>
    </contact>
    <investigator>
      <last_name>Albert J. Chang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>June 8, 2023</last_update_submitted>
  <last_update_submitted_qc>June 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 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>Carcinoma, Renal Cell</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/NCT04473781
org study id: 19-001258
secondary id: NCI-2020-04542
nct id: NCT04473781
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This phase I/II trial investigates the side effects of interstitial brachytherapy and to see
      how well it works in limiting the growth of large kidney cancer masses in patients with
      kidney cancer that have refused or are unable to undergo surgery or ablation
      (unresectable/unablatable). Brachytherapy, also known as internal radiation therapy,
      temporarily introduces a radiation source into or near the tumor to eradicate the tumor
      cells. Giving brachytherapy may potentially reduce the size of the kidney cancer mass that
      would otherwise not be amenable to surgical management and translate into lower risk of
      spread.
PRIMARY OBJECTIVES:

      I. To determine the safety and feasibility of renal interstitial radiation therapy
      (interstitial brachytherapy). (Safety Lead-In) II. To evaluate local control of renal
      interstitial brachytherapy. (Expansion Phase)

      SECONDARY OBJECTIVES:

      I. To evaluate treatment response of the primary tumor. II. To evaluate 12 month distant
      progression free survival. III. To evaluate the 12 month volumetric growth of the primary
      tumor mass. IV. To determine biomarkers predicting response and resistance to radiation
      treatment.

      OUTLINE:

      Patients undergo interstitial brachytherapy for 1-2 fractions in the absence of disease
      progression or unacceptable toxicity. Patients who undergo 2 fractions may receive both
      fractions in the same day or on 2 separate days over 2 weeks.

      After completion of study treatment, patients are followed up every 3 months for at least 3
      years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose limiting toxicity (DLT)
time frame: From the first administration of study therapy up to 60 days
description: A 3+3 safety lead-in phase will be employed in order to determine the DLT for interstitial renal brachytherapy. Grading of DLTs will follow the guidelines provided in the Common Terminology Criteria for Adverse Events version 5.0 criteria.
measure: One year (12-month) linear growth rate
time frame: At 1 year
description: Adequate local control will be defined as minimal growth kinetics (=< 1 mm/year) on 1 year follow-up.
arm group label: Treatment (interstitial brachytherapy)
arm group type: Experimental
description: Patients undergo interstitial brachytherapy for 1-2 fractions in the absence of disease progression or unacceptable toxicity. Patients who undergo 2 fractions may receive both fractions in the same day or on 2 separate days over 2 weeks.
intervention type: Procedure
intervention name: Interstitial Radiation Therapy
description: Undergo interstitial brachytherapy
arm group label: Treatment (interstitial brachytherapy)
other name: BRACHYTHERAPY, INTERSTITIAL
other name: Implant Radiation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Albert J Chang
role: Principal Investigator
affiliation: UCLA / Jonsson Comprehensive Cancer Center
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma, Renal Cell