<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/NCT02185443</url>
  </required_header>
  <id_info>
    <org_study_id>RT-01/2014</org_study_id>
    <nct_id>NCT02185443</nct_id>
  </id_info>
  <brief_title>Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases</brief_title>
  <official_title>Stereotactic Body Radiation Therapy for the Treatment of Unresectable Liver Metastases in Patients With Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal Neuroendocrine Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto do Cancer do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase II study to determine the efficacy of SBRT to treat liver metastases in&#xD;
      patients with Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal&#xD;
      Neuroendocrine Tumors that are not amenable to surgery. Patients should have no evidence of&#xD;
      extra-hepatic disease or have disease that is planned to be treated with curative intent.&#xD;
&#xD;
      Therefore, SBRT is being considered as a potentially curative procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
  <phase>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>Local Progression Free Survival</measure>
    <time_frame>2 years</time_frame>
    <description>- Local Progression Free Survival of treated lesions in evaluable patients. Local Progression Free Survival will be defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria applied to the Planning Target Volume (PTV) and 1cm around (assessment of marginal failure).&#xD;
Time-to-events will be counted from the date of initiation of treatment. Patients will be considered evaluable if followed for at least 6 months after SBRT. A review after 6 months is due to the transient changes after irradiation that make uncertain radiological evaluation before 6 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toxicity</measure>
    <time_frame>5 years</time_frame>
    <description>treatment related toxicity evaluated by the Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">43</enrollment>
  <condition>Liver Metastases</condition>
  <condition>Colorectal Cancer</condition>
  <condition>Anal Canal Cancer</condition>
  <condition>Gastrointestinal Neuroendocrine Tumors</condition>
  <arm_group>
    <arm_group_label>SBRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>SBRT</intervention_name>
    <description>60Gy in 3 fractions (20Gy/fraction) over 14 days&#xD;
60Gy in 5 fractions (12Gy/fraction) over 18 days if organ at risk constraints cannot be met with fractionation above</description>
    <arm_group_label>SBRT</arm_group_label>
    <other_name>Stereotactic Body Radiation Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Karnofsky Performance Scale (KPS) equal or greater than 70&#xD;
&#xD;
          -  1 to 4 liver metastases with an individual maximum diameter of up to 5 cm&#xD;
&#xD;
          -  Lesions considered unresectable or patients considered unfit for surgery&#xD;
&#xD;
          -  Histology of the primary tumor: colorectal adenocarcinoma, carcinoma of the anal canal&#xD;
             or gastrointestinal neuroendocrine tumors.&#xD;
&#xD;
          -  Absence of evidence of extra-hepatic disease or extra-hepatic disease to be treated&#xD;
             with curative intent.&#xD;
&#xD;
          -  Minimum interval of 2 weeks between systemic chemotherapy and SBRT.&#xD;
&#xD;
          -  Adequate bone marrow function defined as:&#xD;
&#xD;
          -  absolute neutrophils count &gt; 1,800 cells / mm 3&#xD;
&#xD;
          -  platelets &gt; 100,000 cells / mm 3&#xD;
&#xD;
          -  hemoglobin &gt; 8.0 g / dl ( transfusion or other intervention accepted)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant chemotherapy&#xD;
&#xD;
          -  Prior radiotherapy to the upper abdomen&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Underlying Cirrhosis&#xD;
&#xD;
          -  Active hepatitis or clinically significant liver failure&#xD;
&#xD;
          -  Prior invasive neoplasm except for non-melanoma skin cancer, or unless more than five&#xD;
             years without evidence of disease&#xD;
&#xD;
          -  Severe Comorbidity&#xD;
&#xD;
          -  Current anticoagulant treatment&#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>Andre TC Chen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto do Cancer do Estado de Sao Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andre TC Chen, MD, PhD</last_name>
    <phone>55-11- 3893-4540</phone>
    <email>andre.chen@hc.fm.usp.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Karina Moutinho, MD</last_name>
    <phone>55-11-3893-4542</phone>
    <email>kamoutinho@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Instituto do Cancer do Estado de São Paulo</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>01246-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andre TC Chen, MD</last_name>
      <phone>55-11-3893-4540</phone>
      <email>andre.chen@hc.fm.usp.br</email>
    </contact>
    <investigator>
      <last_name>Karina Moutinho, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rachel Riechelman, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>December 15, 2021</last_update_submitted>
  <last_update_submitted_qc>December 15, 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>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Andre Tsin Chih Chen</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>SBRT</keyword>
  <keyword>radiation</keyword>
  <keyword>Neoplasm Metastasis</keyword>
  <keyword>Colorectal Neoplasms</keyword>
  <keyword>Anal Canal</keyword>
  <keyword>Neuroendocrine Tumors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Liver Neoplasms</mesh_term>
    <mesh_term>Neuroendocrine Tumors</mesh_term>
    <mesh_term>Intestinal Neoplasms</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Stomach Neoplasms</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/NCT02185443
org study id: RT-01/2014
nct id: NCT02185443
lead sponsor: 
collaborator: 
has dmc: No
This is a Phase II study to determine the efficacy of SBRT to treat liver metastases in
      patients with Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal
      Neuroendocrine Tumors that are not amenable to surgery. Patients should have no evidence of
      extra-hepatic disease or have disease that is planned to be treated with curative intent.

      Therefore, SBRT is being considered as a potentially curative procedure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Local Progression Free Survival
time frame: 2 years
description: - Local Progression Free Survival of treated lesions in evaluable patients. Local Progression Free Survival will be defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria applied to the Planning Target Volume (PTV) and 1cm around (assessment of marginal failure).
Time-to-events will be counted from the date of initiation of treatment. Patients will be considered evaluable if followed for at least 6 months after SBRT. A review after 6 months is due to the transient changes after irradiation that make uncertain radiological evaluation before 6 months.
measure: Overall Survival
time frame: 5 years
measure: Progression Free Survival
time frame: 5 years
measure: Toxicity
time frame: 5 years
description: treatment related toxicity evaluated by the Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4
arm group label: SBRT
arm group type: Experimental
intervention type: Radiation
intervention name: SBRT
description: 60Gy in 3 fractions (20Gy/fraction) over 14 days
60Gy in 5 fractions (12Gy/fraction) over 18 days if organ at risk constraints cannot be met with fractionation above
arm group label: SBRT
other name: Stereotactic Body Radiation Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andre TC Chen, MD, PhD
role: Principal Investigator
affiliation: Instituto do Cancer do Estado de Sao Paulo
last name: Andre TC Chen, MD, PhD
phone: 55-11- 3893-4540
email: andre.chen@hc.fm.usp.br
last name: Karina Moutinho, MD
phone: 55-11-3893-4542
email: kamoutinho@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Andre Tsin Chih Chen
investigator title: MD, PhD
mesh term: Neoplasm Metastasis
mesh term: Liver Neoplasms
mesh term: Neuroendocrine Tumors
mesh term: Intestinal Neoplasms
mesh term: Pancreatic Neoplasms
mesh term: Stomach Neoplasms