<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/NCT04458597</url>
  </required_header>
  <id_info>
    <org_study_id>SPARTACUS</org_study_id>
    <nct_id>NCT04458597</nct_id>
  </id_info>
  <brief_title>Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus.</brief_title>
  <official_title>Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus: A Phase 1 Pilot Study (SPARTACUS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</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>
      Advanced technology has enabled radiation oncologists to more accurately and precisely target&#xD;
      radiation to areas at risk while maximally sparing healthy tissue. Furthermore, there is&#xD;
      growing evidence demonstrating both safety and efficacy for SBRT. We propose that these&#xD;
      advantages are translatable to the adjuvant treatment of endometrial cancer. We submit that a&#xD;
      prescription dose of 30 Gy in 5 fractions, which equates to a 2 Gy equivalent dose (i.e an&#xD;
      EQD2) (α/β = 10 Gy) of 48 Gy, compares favorably to the EQD2 delivered standardly for&#xD;
      adjuvant treatment (44.25 Gy via 45Gy/25Fx; 50 Gy at vaginal surface for vault brachytherapy)&#xD;
      and therefore should be effective and safe dose in the adjuvant setting. Through precision&#xD;
      delivery and careful dosimetry the treatment should be safe and well tolerated with minimal&#xD;
      impact on patient quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 26, 2020</start_date>
  <completion_date type="Anticipated">April 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2024</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess the acute urinary and bowel toxicities</measure>
    <time_frame>Baseline to 2 years post-treatment.</time_frame>
    <description>Acute urinary and bowel toxicities associated with adjuvant SBRT treatment in the setting of high-risk endometrial cancer will be assessed using the Common Terminology Criteria for Adverse Events.</description>
  </primary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Endometrioid Adenocarcinoma</condition>
  <condition>Serous Carcinoma</condition>
  <condition>Clear Cell Carcinoma</condition>
  <condition>Carcinosarcoma</condition>
  <condition>Dedifferentiated Carcinoma</condition>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Image-guided adjuvant pelvic radiotherapy</intervention_name>
    <description>Image-guided adjuvant pelvic radiotherapy delivered at an SBRT prescription dose of 30 Gy in 5 fractions if feasible, well-tolerated and effective for the adjuvant treatment of high-risk endometrial cancer.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients, who have undergone hysterectomy for curative intent, with histologically&#xD;
             confirmed endometrioid adenocarcinoma, serous or clear cell carcinoma, or&#xD;
             carcinosarcoma or dedifferentiated carcinoma&#xD;
&#xD;
          -  Patient is a candidate for adjuvant pelvic radiation (+/- vault brachytherapy),&#xD;
             meeting one of the following conditions:&#xD;
&#xD;
               -  High grade histology OR&#xD;
&#xD;
               -  Outer-half myometrial invasion and FIGO grade 1-2 OR&#xD;
&#xD;
               -  FIGO stage II - IIIC1 (all gross nodal disease must be resected)&#xD;
&#xD;
          -  Patient is willing and able to give informed consent to participate in this clinical&#xD;
             trial.&#xD;
&#xD;
          -  Age ≥18 years.&#xD;
&#xD;
          -  Patients who are to receive adjuvant systemic therapy in addition to pelvic&#xD;
             radiotherapy will be eligible provided that there is at minimum a 3-week interval&#xD;
             between any radiation treatment and chemotherapy treatments. Adjuvant systemic therapy&#xD;
             may be given before or after radiation treatment.&#xD;
&#xD;
          -  Patient must be willing and able to complete the QLQ-C30 questionnaire with EN-24&#xD;
             companion as described in the study protocol.&#xD;
&#xD;
          -  Primary language of the patient must be English or, if a patient's primary language is&#xD;
             not English, they are still able to participate provided the QLQ-C30 and EN-24 is&#xD;
             available in their primary language.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has had prior pelvic radiotherapy.&#xD;
&#xD;
          -  Patient has received neo-adjuvant systemic therapy&#xD;
&#xD;
          -  Patient has a contraindication to pelvic radiotherapy, such as but not limited to a&#xD;
             connective tissue disease or inflammatory bowel disease.&#xD;
&#xD;
          -  Patient has a contraindication to iodinated CT contrast.&#xD;
&#xD;
          -  Patient has a hip prosthesis.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David D'Souza, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>London Regional Cancer Program</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Regional Cancer Program</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>March 7, 2023</last_update_submitted>
  <last_update_submitted_qc>March 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 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</mesh_term>
    <mesh_term>Carcinoma, Endometrioid</mesh_term>
    <mesh_term>Carcinosarcoma</mesh_term>
    <mesh_term>Cystadenocarcinoma, Serous</mesh_term>
    <mesh_term>Adenomyoepithelioma</mesh_term>
    <mesh_term>Adenocarcinoma, Clear Cell</mesh_term>
    <mesh_term>Uterine 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/NCT04458597
org study id: SPARTACUS
nct id: NCT04458597
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Advanced technology has enabled radiation oncologists to more accurately and precisely target
      radiation to areas at risk while maximally sparing healthy tissue. Furthermore, there is
      growing evidence demonstrating both safety and efficacy for SBRT. We propose that these
      advantages are translatable to the adjuvant treatment of endometrial cancer. We submit that a
      prescription dose of 30 Gy in 5 fractions, which equates to a 2 Gy equivalent dose (i.e an
      EQD2) (α/β = 10 Gy) of 48 Gy, compares favorably to the EQD2 delivered standardly for
      adjuvant treatment (44.25 Gy via 45Gy/25Fx; 50 Gy at vaginal surface for vault brachytherapy)
      and therefore should be effective and safe dose in the adjuvant setting. Through precision
      delivery and careful dosimetry the treatment should be safe and well tolerated with minimal
      impact on patient quality of life.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Assess the acute urinary and bowel toxicities
time frame: Baseline to 2 years post-treatment.
description: Acute urinary and bowel toxicities associated with adjuvant SBRT treatment in the setting of high-risk endometrial cancer will be assessed using the Common Terminology Criteria for Adverse Events.
intervention type: Radiation
intervention name: Image-guided adjuvant pelvic radiotherapy
description: Image-guided adjuvant pelvic radiotherapy delivered at an SBRT prescription dose of 30 Gy in 5 fractions if feasible, well-tolerated and effective for the adjuvant treatment of high-risk endometrial cancer.
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David D'Souza, M.D.
role: Principal Investigator
affiliation: London Regional Cancer Program
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Endometrioid
mesh term: Carcinosarcoma
mesh term: Cystadenocarcinoma, Serous
mesh term: Adenomyoepithelioma
mesh term: Adenocarcinoma, Clear Cell
mesh term: Uterine Neoplasms