<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/NCT03811665</url>
  </required_header>
  <id_info>
    <org_study_id>RADSTER</org_study_id>
    <nct_id>NCT03811665</nct_id>
  </id_info>
  <brief_title>Stereotactic Body Radiation Therapy Versus Radiofrequency Ablation for Small Renal Masses</brief_title>
  <acronym>SBRT vs RFA</acronym>
  <official_title>A Prospective Randomized Pilot Trial of Stereotactive Body Radiation Therapy Versus Radiofrequency Ablation for the Management of Small Renal Masses.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Joseph's Healthcare Hamilton</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Joseph's Healthcare Hamilton</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The execution of this study is pertinent to evaluating SBRT's short- and long-term efficacy&#xD;
      and safety in the treatment of SRMs. This study will be the first to compare RFA and SBRT in&#xD;
      the treatment of SRMs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment failure</measure>
    <time_frame>12 Months</time_frame>
    <description>Failure will be defined as enhancement of ablated tissue greater than 10 Hounsfield units by CT contrast.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>12 Months</time_frame>
    <description>Defined as post-procedural survival.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease free survival</measure>
    <time_frame>12 Months</time_frame>
    <description>Defined as disease-free survival rate after a single procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease recurrence</measure>
    <time_frame>12 Months</time_frame>
    <description>Defined as disease recurrence rate after a single procedure, including positive biopsy result.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tumour Size</measure>
    <time_frame>12 Months</time_frame>
    <description>Average percentage decrease in tumor size.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Function -eGFR</measure>
    <time_frame>12 Months</time_frame>
    <description>Change in eGRF measured by mL/min/1.73m2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Function - Serum Creatinine</measure>
    <time_frame>12 Months</time_frame>
    <description>Change in serum creatinine level measured by umol/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Function - Creatinine Clearance</measure>
    <time_frame>12 Months</time_frame>
    <description>Change in creatinine clearance measured by ml/minute.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication Rate</measure>
    <time_frame>12 Months</time_frame>
    <description>Intra and post intervention complication rates will be documented in terms of nausea, vomiting, diarrhea, hematuria, hemorrhage (requiring or not requiring transfusion), perinephric hematoma, ureteral strictures, loss of a renal unit, urinary leak, bleeding, fever and flulike symptoms, stomach/bowel ulceration, ureteropelvic junction obstruction, and upper pole hydrocalycosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients that experienced an adverse event.</measure>
    <time_frame>12 Months</time_frame>
    <description>Defined by any adverse event listed in the CTCAE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in score for quality of life</measure>
    <time_frame>12 Months</time_frame>
    <description>Defined by the generic EuroQol (EQ-5D) questionnaire that is a standardized measure of health. A scale of 0-100 (0 being the worse health, and 100 being the best health), is used for a patient to define their overall health and wellbeing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital stay</measure>
    <time_frame>Days</time_frame>
    <description>Duration of length of hospital stay (if applicable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost analysis</measure>
    <time_frame>12 Months</time_frame>
    <description>Defined by total cost of procedure and any associated related adverse events post procedure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Small Renal Masses (SRM)</condition>
  <arm_group>
    <arm_group_label>Stereotactic body radiation therapy (SBRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Radiofrequency Ablation (RFA)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radiofrequency Ablation</intervention_name>
    <description>RFA probe will create an ablation zone of a 1.0 cm diameter beyond the maximum CT-measured tumor diameter. The generator will modulate power up to 150 W in reach average ablative temperature of 105oC. Tumors will be treated for two cycles of 8 minutes duration each upon reaching target temperatures.</description>
    <arm_group_label>Radiofrequency Ablation (RFA)</arm_group_label>
    <other_name>RFA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactive body radiation therapy</intervention_name>
    <description>The Gross Tumour Volume (GTV) is defined as the visible tumour seen on the planning CT simulation. No clinical target volume (CTV) for microscopic disease is necessary. The internal target volume (ITV) accounts for changes in tumour position due to respiration, and is assessed on 4DCT. The planning target volume (PTV) will be a standard 0.5 cm around the ITV.</description>
    <arm_group_label>Stereotactic body radiation therapy (SBRT)</arm_group_label>
    <other_name>SBRT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ≥18 years of age and capable of providing informed consent&#xD;
&#xD;
          -  Patients scheduled for treatment of their SRM using SBRT or RFA&#xD;
&#xD;
          -  Patients who received a biopsy of their SRM prior to their scheduled SBRT or RFA&#xD;
             treatment&#xD;
&#xD;
          -  Patients who are willing to have a biopsy 12 months post-procedure&#xD;
&#xD;
          -  Patients with renal tumor(s) ≤ 4.0 cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with large renal tumor(s)&gt;4.0 cm&#xD;
&#xD;
          -  Patients who are unable to have a general anesthetic&#xD;
&#xD;
          -  Patients who did not receive a biopsy of their SRM prior to their scheduled SBRT or&#xD;
             RFA treatment&#xD;
&#xD;
          -  Patients who are unable to comply with post-operative and/or follow-up protocol/phase&#xD;
             of study&#xD;
&#xD;
          -  Evidence of metastatic disease&#xD;
&#xD;
          -  Uncorrectable bleeding diathesis&#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>Anil Kapoor, MD FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Joseph's Healthcare Hamilton</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McMaster Institute of Urology - St. Joseph's Healthcare Hamilton</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 4A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>December 14, 2021</last_update_submitted>
  <last_update_submitted_qc>December 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Joseph's Healthcare Hamilton</investigator_affiliation>
    <investigator_full_name>Anil Kapoor</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT03811665
org study id: RADSTER
nct id: NCT03811665
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The execution of this study is pertinent to evaluating SBRT's short- and long-term efficacy
      and safety in the treatment of SRMs. This study will be the first to compare RFA and SBRT in
      the treatment of SRMs.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Treatment failure
time frame: 12 Months
description: Failure will be defined as enhancement of ablated tissue greater than 10 Hounsfield units by CT contrast.
measure: Overall Survival
time frame: 12 Months
description: Defined as post-procedural survival.
measure: Disease free survival
time frame: 12 Months
description: Defined as disease-free survival rate after a single procedure
measure: Disease recurrence
time frame: 12 Months
description: Defined as disease recurrence rate after a single procedure, including positive biopsy result.
measure: Tumour Size
time frame: 12 Months
description: Average percentage decrease in tumor size.
measure: Renal Function -eGFR
time frame: 12 Months
description: Change in eGRF measured by mL/min/1.73m2.
measure: Renal Function - Serum Creatinine
time frame: 12 Months
description: Change in serum creatinine level measured by umol/L.
measure: Renal Function - Creatinine Clearance
time frame: 12 Months
description: Change in creatinine clearance measured by ml/minute.
measure: Complication Rate
time frame: 12 Months
description: Intra and post intervention complication rates will be documented in terms of nausea, vomiting, diarrhea, hematuria, hemorrhage (requiring or not requiring transfusion), perinephric hematoma, ureteral strictures, loss of a renal unit, urinary leak, bleeding, fever and flulike symptoms, stomach/bowel ulceration, ureteropelvic junction obstruction, and upper pole hydrocalycosis.
measure: Number of patients that experienced an adverse event.
time frame: 12 Months
description: Defined by any adverse event listed in the CTCAE.
measure: Change in score for quality of life
time frame: 12 Months
description: Defined by the generic EuroQol (EQ-5D) questionnaire that is a standardized measure of health. A scale of 0-100 (0 being the worse health, and 100 being the best health), is used for a patient to define their overall health and wellbeing.
measure: Duration of hospital stay
time frame: Days
description: Duration of length of hospital stay (if applicable)
measure: Cost analysis
time frame: 12 Months
description: Defined by total cost of procedure and any associated related adverse events post procedure.
arm group label: Stereotactic body radiation therapy (SBRT)
arm group type: Experimental
arm group label: Radiofrequency Ablation (RFA)
arm group type: Active Comparator
intervention type: Procedure
intervention name: Radiofrequency Ablation
description: RFA probe will create an ablation zone of a 1.0 cm diameter beyond the maximum CT-measured tumor diameter. The generator will modulate power up to 150 W in reach average ablative temperature of 105oC. Tumors will be treated for two cycles of 8 minutes duration each upon reaching target temperatures.
arm group label: Radiofrequency Ablation (RFA)
other name: RFA
intervention type: Radiation
intervention name: Stereotactive body radiation therapy
description: The Gross Tumour Volume (GTV) is defined as the visible tumour seen on the planning CT simulation. No clinical target volume (CTV) for microscopic disease is necessary. The internal target volume (ITV) accounts for changes in tumour position due to respiration, and is assessed on 4DCT. The planning target volume (PTV) will be a standard 0.5 cm around the ITV.
arm group label: Stereotactic body radiation therapy (SBRT)
other name: SBRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anil Kapoor, MD FRCSC
role: Principal Investigator
affiliation: St. Joseph's Healthcare Hamilton
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: St. Joseph's Healthcare Hamilton
investigator full name: Anil Kapoor
investigator title: Principal Investigator
sharing ipd: Undecided