<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/NCT01676428</url>
  </required_header>
  <id_info>
    <org_study_id>11/106</org_study_id>
    <secondary_id>U1111-1132-5574</secondary_id>
    <nct_id>NCT01676428</nct_id>
  </id_info>
  <brief_title>A Pilot Study of Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases</brief_title>
  <acronym>FASTRACK</acronym>
  <official_title>A Pilot Study of Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peter MacCallum Cancer Centre, Australia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peter MacCallum Cancer Centre, Australia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a &quot;proof of concept&quot; study, to assess the feasibility of introducing a novel&#xD;
      high-precision radiotherapy technique called &quot;stereotactic radiosurgery&quot; (SRS) or&#xD;
      &quot;stereotactic body radiotherapy&quot; (SBRT) for the treatment of kidney cancers in Australia.&#xD;
      This study aims to invite 20 patients with renal cell carcinoma and 10 patients with isolated&#xD;
      adrenal metastases from non-small cell carcinoma who are either medically inoperable, high&#xD;
      risk for surgery, or decline surgery to participate. In cohort of patients with renal cell&#xD;
      carcinoma, both patients with primary disease only, and those patients who have limited&#xD;
      metastases (≤5) will be eligible. Besides technical feasibility of delivering this treatment,&#xD;
      this study will be to assess efficacy, toxicity and tumour response using a novel imaging&#xD;
      biomarker called diffusion weighted-MRI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      FASTRACK is a 2 -cohort, non-randomised prospective feasibility study. Anticipated total&#xD;
      duration of accrual is approximately 24 months, with all patients expected to complete all&#xD;
      protocol treatment and imaging within a further 3 months. The trial will close after the last&#xD;
      patient has completed his/her last protocol related follow-up visit (at 12 months&#xD;
      post-treatment).&#xD;
&#xD;
      Cohort 1: patients with renal cell carcinoma within the kidney Cohort 2: patients with&#xD;
      solitary adrenal metastases from non-small cell lung carcinoma The investigational treatment&#xD;
      will be prescribed the covering isodose, ensuring that 99% of the PTV is covered by 100% of&#xD;
      the dose (D99=100%). It is anticipated that most treatments should be highly conformal.&#xD;
      Treatment must be delivered with at least six (6) non-opposing conformal megavoltage photon&#xD;
      beams. It is anticipated that a typical range of beam numbers would be 8 to 12, comprising of&#xD;
      at least 6 co-planar beams and 1-2 non-coplanar beams. No cytotoxic chemotherapy is allowed&#xD;
      within 3 weeks or concurrently with respect to the investigational treatment. Consultation&#xD;
      with the treating radiation oncologist is strongly recommended if chemotherapy is to be&#xD;
      considered after the investigational treatment and before documented disease progression, to&#xD;
      prevent unforeseen combined toxicities. Targeted agents (such as sunitinib) are exempt from&#xD;
      this recommendation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">October 2014</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>The number of patients who complete prescribed treatment.</measure>
    <time_frame>After 24 months</time_frame>
    <description>This is defined as patients who successfully receive the treatment plan as prescribed, achieving all nominated dose constraints, and are able to tolerate the treatment(s)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Toxicity of SBRT in study patients measured using CTCAE V4.0</measure>
    <time_frame>Between 2-4 weeks after radiotherapy and 3 monthly for 12 months</time_frame>
    <description>Specific toxicities will include, but are not limited to;&#xD;
Gastrointestinal (Nausea, vomiting, diarrhoea, acute ulceration)&#xD;
Pulmonary (atelectasis, cough, dyspnoea, hypoxia, pleural effusion, fibrosis)&#xD;
Skin/chest wall (radiation dermatitis, rib fracture)&#xD;
Kidney (acute renal dysfunction) Freedom from severe toxicity will be reported asn defined as: time from treatment delivery until first recorded grade 4, or 5 toxicity as measured by CTCAE V4.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of stereotactic radiosurgery</measure>
    <time_frame>1 year after treatment</time_frame>
    <description>Effective SBRT is defined as a treatment which results in local control at 1 year after treatment. Local control is defined as lack of progression of the target lesion as measured by RECIST criteria. RECIST criteria are a CT evaluation of change in tumour size.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of using Diffusion weighted-MRI for response assessment.</measure>
    <time_frame>At Baseline, 14 days (+/-3 days) and at the definitive response assessment (70days +/-10days)</time_frame>
    <description>Feasibility will be measured by the quality of image of the diffusion weighted-MRI recorded by the investigating radiologists.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The interventional treatment will be prescribed as a 2-tiered dose scheduled dependant of target size.&#xD;
For lesions &lt;5cm, a single fraction of 26 Gy will be prescribed. For lesions ≥5cm a fractionated course of 15Gy by 3 fractions will be prescribed, delivered at least 48 hours apart.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <description>The investigational treatment will be prescribed as a 2-tiered dose scheduled dependant on target size.&#xD;
For lesions &lt;5cm, a single fraction of 26Gy will be prescribed. For lesions ≥5cm a fractionated course of 14Gy by 3 fractions will be prescribed, delivered at least 48 hours apart.</description>
    <arm_group_label>Radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
          -  All patients must have radiological diagnosis or biopsy confirmed diagnosis of either:&#xD;
&#xD;
               1. Cohort 1: renal cell carcinoma with a single lesion within kidney, or with&#xD;
                  primary kidney tumour intact and no more than 5 documented metastases, or&#xD;
&#xD;
               2. Cohort 2: single adrenal metastases with extra-adrenal disease controlled&#xD;
&#xD;
          -  ECOG performance of 0-2 inclusive.&#xD;
&#xD;
          -  Either medically inoperable, technically high risk for surgery or decline surgery.&#xD;
&#xD;
          -  Informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently&#xD;
             with treatment. Delivery of targeted agents (such as sunitinib) are allowable only&#xD;
             when at least 7 days separate the delivery of the proposed agent and the delivery of&#xD;
             the stereotactic radiotherapy.&#xD;
&#xD;
          -  Previous high-dose radiotherapy to upper abdomen&#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>Shankar Siva</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peter MacCallum Cancer Centre, Australia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peter MacCallum Cancer Centre</name>
      <address>
        <city>East Melbourne</city>
        <state>Victoria</state>
        <zip>3002</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>October 30, 2016</last_update_submitted>
  <last_update_submitted_qc>October 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Kidney</keyword>
  <keyword>Renal</keyword>
  <keyword>Radiotherapy</keyword>
  <keyword>Stereotactic</keyword>
  <keyword>Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Neoplasms</mesh_term>
    <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/NCT01676428
org study id: 11/106
secondary id: U1111-1132-5574
nct id: NCT01676428
lead sponsor: 
has dmc: Yes
This is a "proof of concept" study, to assess the feasibility of introducing a novel
      high-precision radiotherapy technique called "stereotactic radiosurgery" (SRS) or
      "stereotactic body radiotherapy" (SBRT) for the treatment of kidney cancers in Australia.
      This study aims to invite 20 patients with renal cell carcinoma and 10 patients with isolated
      adrenal metastases from non-small cell carcinoma who are either medically inoperable, high
      risk for surgery, or decline surgery to participate. In cohort of patients with renal cell
      carcinoma, both patients with primary disease only, and those patients who have limited
      metastases (≤5) will be eligible. Besides technical feasibility of delivering this treatment,
      this study will be to assess efficacy, toxicity and tumour response using a novel imaging
      biomarker called diffusion weighted-MRI.
FASTRACK is a 2 -cohort, non-randomised prospective feasibility study. Anticipated total
      duration of accrual is approximately 24 months, with all patients expected to complete all
      protocol treatment and imaging within a further 3 months. The trial will close after the last
      patient has completed his/her last protocol related follow-up visit (at 12 months
      post-treatment).

      Cohort 1: patients with renal cell carcinoma within the kidney Cohort 2: patients with
      solitary adrenal metastases from non-small cell lung carcinoma The investigational treatment
      will be prescribed the covering isodose, ensuring that 99% of the PTV is covered by 100% of
      the dose (D99=100%). It is anticipated that most treatments should be highly conformal.
      Treatment must be delivered with at least six (6) non-opposing conformal megavoltage photon
      beams. It is anticipated that a typical range of beam numbers would be 8 to 12, comprising of
      at least 6 co-planar beams and 1-2 non-coplanar beams. No cytotoxic chemotherapy is allowed
      within 3 weeks or concurrently with respect to the investigational treatment. Consultation
      with the treating radiation oncologist is strongly recommended if chemotherapy is to be
      considered after the investigational treatment and before documented disease progression, to
      prevent unforeseen combined toxicities. Targeted agents (such as sunitinib) are exempt from
      this recommendation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The number of patients who complete prescribed treatment.
time frame: After 24 months
description: This is defined as patients who successfully receive the treatment plan as prescribed, achieving all nominated dose constraints, and are able to tolerate the treatment(s)
measure: Toxicity of SBRT in study patients measured using CTCAE V4.0
time frame: Between 2-4 weeks after radiotherapy and 3 monthly for 12 months
description: Specific toxicities will include, but are not limited to;
Gastrointestinal (Nausea, vomiting, diarrhoea, acute ulceration)
Pulmonary (atelectasis, cough, dyspnoea, hypoxia, pleural effusion, fibrosis)
Skin/chest wall (radiation dermatitis, rib fracture)
Kidney (acute renal dysfunction) Freedom from severe toxicity will be reported asn defined as: time from treatment delivery until first recorded grade 4, or 5 toxicity as measured by CTCAE V4.0.
measure: Efficacy of stereotactic radiosurgery
time frame: 1 year after treatment
description: Effective SBRT is defined as a treatment which results in local control at 1 year after treatment. Local control is defined as lack of progression of the target lesion as measured by RECIST criteria. RECIST criteria are a CT evaluation of change in tumour size.
measure: Feasibility of using Diffusion weighted-MRI for response assessment.
time frame: At Baseline, 14 days (+/-3 days) and at the definitive response assessment (70days +/-10days)
description: Feasibility will be measured by the quality of image of the diffusion weighted-MRI recorded by the investigating radiologists.
arm group label: Radiotherapy
arm group type: Experimental
description: The interventional treatment will be prescribed as a 2-tiered dose scheduled dependant of target size.
For lesions <5cm, a single fraction of 26 Gy will be prescribed. For lesions ≥5cm a fractionated course of 15Gy by 3 fractions will be prescribed, delivered at least 48 hours apart.
intervention type: Radiation
intervention name: Radiotherapy
description: The investigational treatment will be prescribed as a 2-tiered dose scheduled dependant on target size.
For lesions <5cm, a single fraction of 26Gy will be prescribed. For lesions ≥5cm a fractionated course of 14Gy by 3 fractions will be prescribed, delivered at least 48 hours apart.
arm group label: Radiotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shankar Siva
role: Principal Investigator
affiliation: Peter MacCallum Cancer Centre, Australia
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Kidney Neoplasms
mesh term: Carcinoma, Renal Cell