<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/NCT02206230</url>
  </required_header>
  <id_info>
    <org_study_id>BR-02-1401</org_study_id>
    <nct_id>NCT02206230</nct_id>
  </id_info>
  <brief_title>Trial of Hypofractionated Radiation Therapy for Glioblastoma</brief_title>
  <official_title>A Randomized Controlled Trial of Conventional Versus Hypofractionated Radiation Therapy With Temozolomide for Patients With Newly Diagnosed Glioblastoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AHS Cancer Control Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cross Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AHS Cancer Control Alberta</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being done to compare standard radiation therapy with hypofractionated&#xD;
      radiation therapy for patients with newly diagnosed glioblastoma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypofractionated radiation therapy (RT) in the treatment of patients with glioblastoma, 18 -&#xD;
      70 years of age with good performance status (ECOG 0 - 2), will be well tolerated and yield&#xD;
      survival non-inferior to conventional fractioned RT, allowing significant abbreviation of the&#xD;
      length of the radiation course required for these patients with limited survival. The&#xD;
      importance of hypofractionation is, therefore, not in improving survival, but rather to&#xD;
      shorten RT duration to improve patient comfort and convenience. This approach is pertinent&#xD;
      given the limited life expectancy of glioblastoma and has been used in patients with&#xD;
      prolonged survival including breast and prostate cancers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Up to 24 months from date of randomization to date of death due to any cause</time_frame>
    <description>Patients without an event will be censored the last time they were known to be alive</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>Up to 24 month where PFS is defined as the time between randomization and radiographic progression based on RECIST criteria or death due to any cause.</time_frame>
    <description>Patients without an event will be assessed at the date of last follow-up for progression. Patients with no post-baseline follow-up for progression will be censored at the day of randomization.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">132</enrollment>
  <condition>Glioblastoma</condition>
  <arm_group>
    <arm_group_label>Hypofractionated radiation therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hypofractionated radiation therapy of 60 Gy in 20 fractions (3 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 4-week break, temozolomide days 1-5 every 28 days for 6 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard radiation therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard radiation therapy of 60 Gy in 30 fractions (2 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 4-week break, temozolomide days 1-5 every 28 days for 6 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Hypofractionated radiation therapy</intervention_name>
    <arm_group_label>Hypofractionated radiation therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Standard radiation therapy</intervention_name>
    <arm_group_label>Standard radiation therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed, histologically proven intracranial glioblastoma or gliosarcoma&#xD;
&#xD;
          -  History and physical exam within 14 days prior to randomization&#xD;
&#xD;
          -  Between 18 and 70 years of age&#xD;
&#xD;
          -  ECOG 0 - 2&#xD;
&#xD;
          -  Stable or decreasing dose of corticosteroids for at least 14 days prior to&#xD;
             randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior invasive malignancy unless disease free for &gt; 3 years&#xD;
&#xD;
          -  Prior head or neck RT (except for glottic cancer) or systemic therapy precluding&#xD;
             delivery of concurrent and adjuvant temozolomide&#xD;
&#xD;
          -  Treatment with any other therapeutic clinical protocol within 30 days prior to study&#xD;
             registration or during participation in the study&#xD;
&#xD;
          -  Specific severe, active co-morbidities&#xD;
&#xD;
          -  Not willing or able to use medically acceptable forms of contraception&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samir Patel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cross Cancer Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Samir Patel, MD</last_name>
    <phone>780-432-8783</phone>
    <email>samir.patel2@albertahealthservices.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samir Patel, MD</last_name>
      <phone>780-432-8518</phone>
      <email>samir.patel2@albertahealthservices.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>December 31, 2015</last_update_submitted>
  <last_update_submitted_qc>December 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>glioblastoma</keyword>
  <keyword>radiotherapy</keyword>
  <keyword>hypofractionated radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</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/NCT02206230
org study id: BR-02-1401
nct id: NCT02206230
lead sponsor: 
collaborator: 
has dmc: Yes
This study is being done to compare standard radiation therapy with hypofractionated
      radiation therapy for patients with newly diagnosed glioblastoma
Hypofractionated radiation therapy (RT) in the treatment of patients with glioblastoma, 18 -
      70 years of age with good performance status (ECOG 0 - 2), will be well tolerated and yield
      survival non-inferior to conventional fractioned RT, allowing significant abbreviation of the
      length of the radiation course required for these patients with limited survival. The
      importance of hypofractionation is, therefore, not in improving survival, but rather to
      shorten RT duration to improve patient comfort and convenience. This approach is pertinent
      given the limited life expectancy of glioblastoma and has been used in patients with
      prolonged survival including breast and prostate cancers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival
time frame: Up to 24 months from date of randomization to date of death due to any cause
description: Patients without an event will be censored the last time they were known to be alive
measure: Progression-free survival (PFS)
time frame: Up to 24 month where PFS is defined as the time between randomization and radiographic progression based on RECIST criteria or death due to any cause.
description: Patients without an event will be assessed at the date of last follow-up for progression. Patients with no post-baseline follow-up for progression will be censored at the day of randomization.
arm group label: Hypofractionated radiation therapy
arm group type: Experimental
description: Hypofractionated radiation therapy of 60 Gy in 20 fractions (3 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 4-week break, temozolomide days 1-5 every 28 days for 6 cycles.
arm group label: Standard radiation therapy
arm group type: Active Comparator
description: Standard radiation therapy of 60 Gy in 30 fractions (2 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 4-week break, temozolomide days 1-5 every 28 days for 6 cycles.
intervention type: Radiation
intervention name: Hypofractionated radiation therapy
arm group label: Hypofractionated radiation therapy
intervention type: Radiation
intervention name: Standard radiation therapy
arm group label: Standard radiation therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Samir Patel, MD
role: Principal Investigator
affiliation: Cross Cancer Institute
last name: Samir Patel, MD
phone: 780-432-8783
email: samir.patel2@albertahealthservices.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Sponsor
mesh term: Glioblastoma