<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/NCT04506008</url>
  </required_header>
  <id_info>
    <org_study_id>VICC SAR 2062</org_study_id>
    <nct_id>NCT04506008</nct_id>
  </id_info>
  <brief_title>Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas</brief_title>
  <official_title>Prospective Observational Trial of Two Neoadjuvant Hypofractionated Radiotherapy Regimens Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt-Ingram Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt-Ingram 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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection&#xD;
      in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter&#xD;
      course (5 or 15 days of radiation) compared to the traditional 5 week regimen. It is proposed&#xD;
      that this will be possible without increasing the risk of wound complication or local&#xD;
      recurrence compared with a traditional 5 week course of pre-operative radiation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Objectives:&#xD;
&#xD;
      Primary:&#xD;
&#xD;
        -  To investigate the efficacy of neoadjuvant hypo-fractionated radiotherapy (HRT) followed&#xD;
           by surgical resection in the treatment of soft tissue sarcoma (STS) as measured by local&#xD;
           control&#xD;
&#xD;
        -  Examine the side effect profile using Radiation Therapy Oncology Group (RTOG) and Common&#xD;
           Terminology Criteria for Adverse Events (CTCAE) acute and late side effects criteria and&#xD;
           major and minor post-operative complication rates.&#xD;
&#xD;
      OUTLINE: Patients are assigned to 1 of 2 groups by the radiation oncologist.&#xD;
&#xD;
      GROUP I (ULTRA-HYPOFRACTIONATION [UH]): Patients undergo HRT daily for a total of 5 fractions&#xD;
      followed by surgery.&#xD;
&#xD;
      GROUP II (MODERATE HYPOFRACTIONATION [MH]): Patients undergo HRT daily for a total of 15&#xD;
      fractions followed by surgery.&#xD;
&#xD;
      After completion of study treatment, patients are followed up within 3 months, then every 3-6&#xD;
      months for a minimum of 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 2, 2021</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Local control rate</measure>
    <time_frame>Approximately 2 years</time_frame>
    <description>Will be estimated with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution. The median and a 95% credible interval of the posterior distribution will be reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>Approximately 2 years</time_frame>
    <description>The complication rate will be modeled with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution, and it will be monitored continuously throughout the study. The complication rate will also be modeled with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution, and it will be monitored continuously throughout the study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Soft Tissue Sarcomas</condition>
  <arm_group>
    <arm_group_label>Group I (UH HRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo HRT daily for a total of 5 fractions followed by surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (MH HRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo HRT daily for a total of 15 fractions followed by surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Ultra-Hypo-fractionation Radiotherapy</intervention_name>
    <description>Five fractions of pre-operative radiation</description>
    <arm_group_label>Group I (UH HRT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Resection</intervention_name>
    <description>Surgery</description>
    <arm_group_label>Group I (UH HRT)</arm_group_label>
    <arm_group_label>Group II (MH HRT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (UH HRT)</arm_group_label>
    <arm_group_label>Group II (MH HRT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Moderately-Hypo-fractionation Radiotherapy</intervention_name>
    <description>15 fractions of pre-operative radiation</description>
    <arm_group_label>Group II (MH HRT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologic diagnosis of a soft tissue sarcoma of extremity, pelvis, chest wall or&#xD;
             trunk/abdominal wall (non-retroperitoneal location)&#xD;
&#xD;
          -  ECOG performance status 0-2&#xD;
&#xD;
          -  Patient must be deemed able to comply with radiation treatment and surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of prior radiation to the same area to be irradiated&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Active collagen vascular disease or patients genetically predisposed to increased&#xD;
             radiation related side effects&#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>Eric Shinohara, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vanderbilt-Ingram Service for Timely Access</last_name>
    <phone>800-811-8480</phone>
    <email>cip@vumc.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Vanderbilt-Ingram Cancer Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanderbilt-Ingram Service for Timely Access</last_name>
      <phone>800-811-8480</phone>
      <email>cip@vumc.org</email>
    </contact>
    <investigator>
      <last_name>Eric Shinohara, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>July 28, 2023</last_update_submitted>
  <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt-Ingram Cancer Center</investigator_affiliation>
    <investigator_full_name>Eric Shinohara</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hypofractionated Radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04506008
org study id: VICC SAR 2062
nct id: NCT04506008
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection
      in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter
      course (5 or 15 days of radiation) compared to the traditional 5 week regimen. It is proposed
      that this will be possible without increasing the risk of wound complication or local
      recurrence compared with a traditional 5 week course of pre-operative radiation.
Study Objectives:

      Primary:

        -  To investigate the efficacy of neoadjuvant hypo-fractionated radiotherapy (HRT) followed
           by surgical resection in the treatment of soft tissue sarcoma (STS) as measured by local
           control

        -  Examine the side effect profile using Radiation Therapy Oncology Group (RTOG) and Common
           Terminology Criteria for Adverse Events (CTCAE) acute and late side effects criteria and
           major and minor post-operative complication rates.

      OUTLINE: Patients are assigned to 1 of 2 groups by the radiation oncologist.

      GROUP I (ULTRA-HYPOFRACTIONATION [UH]): Patients undergo HRT daily for a total of 5 fractions
      followed by surgery.

      GROUP II (MODERATE HYPOFRACTIONATION [MH]): Patients undergo HRT daily for a total of 15
      fractions followed by surgery.

      After completion of study treatment, patients are followed up within 3 months, then every 3-6
      months for a minimum of 2 years.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Local control rate
time frame: Approximately 2 years
description: Will be estimated with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution. The median and a 95% credible interval of the posterior distribution will be reported.
measure: Complication rate
time frame: Approximately 2 years
description: The complication rate will be modeled with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution, and it will be monitored continuously throughout the study. The complication rate will also be modeled with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution, and it will be monitored continuously throughout the study.
arm group label: Group I (UH HRT)
arm group type: Experimental
description: Patients undergo HRT daily for a total of 5 fractions followed by surgery.
arm group label: Group II (MH HRT)
arm group type: Experimental
description: Patients undergo HRT daily for a total of 15 fractions followed by surgery.
intervention type: Radiation
intervention name: Ultra-Hypo-fractionation Radiotherapy
description: Five fractions of pre-operative radiation
arm group label: Group I (UH HRT)
intervention type: Procedure
intervention name: Resection
description: Surgery
arm group label: Group I (UH HRT)
arm group label: Group II (MH HRT)
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Group I (UH HRT)
arm group label: Group II (MH HRT)
intervention type: Radiation
intervention name: Moderately-Hypo-fractionation Radiotherapy
description: 15 fractions of pre-operative radiation
arm group label: Group II (MH HRT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eric Shinohara, MD
role: Principal Investigator
affiliation: Vanderbilt Medical Center
last name: Vanderbilt-Ingram Service for Timely Access
phone: 800-811-8480
email: cip@vumc.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt-Ingram Cancer Center
investigator full name: Eric Shinohara
investigator title: Principal Investigator
mesh term: Sarcoma
sharing ipd: No