<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/NCT04471844</url>
  </required_header>
  <id_info>
    <org_study_id>TRIDENT EF-32</org_study_id>
    <nct_id>NCT04471844</nct_id>
  </id_info>
  <brief_title>Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT &amp; TMZ for the Treatment of Newly Diagnosed GBM</brief_title>
  <acronym>EF-32</acronym>
  <official_title>EF-32: Pivotal, Randomized, Open-Label Study of Optune® (Tumor Treating Fields, 200kHz) Concomitant With Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NovoCure GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NovoCure Ltd.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      To test the effectiveness and safety of Optune® given concomitantly with radiation therapy&#xD;
      (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy&#xD;
      and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued&#xD;
      following radiation therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Optune® is a medical device that has been approved for the treatment of recurrent and newly&#xD;
      diagnosed glioblastoma (GBM) by the Food and Drug Administration (FDA) in the United States.&#xD;
      Optune® has obtained a CE mark in Europe for recurrent and newly diagnosed GBM.&#xD;
&#xD;
      The current standard of care for GBM includes the addition of Optune® to maintenance&#xD;
      temozolomide (TMZ), following the completion of radiation therapy (RT).&#xD;
&#xD;
      The purpose of the current study is to test if the earlier introduction of Optune®, at the&#xD;
      time of radiation therapy (which is given together with temozolomide), improves clinical&#xD;
      outcomes compared to the standard of care.&#xD;
&#xD;
      The study will randomize 950 subjects equally to one of two treatment arms:&#xD;
&#xD;
        1. Treatment arm I: Patients receive TTFields at 200 kHz to the brain using the Optune®&#xD;
           System together with RT and TMZ, followed by maintenance TMZ concomitant with the&#xD;
           Optune® treatment.&#xD;
&#xD;
        2. Treatment arm II: Patients receive RT and TMZ alone, followed by maintenance TMZ&#xD;
           concomitant with TTFields at 200 kHz to the brain using the Optune®.&#xD;
&#xD;
      All patients are to receive standard RT and TMZ treatment followed by maintenance TMZ&#xD;
      chemotherapy and Optune® according to the current standard of care regimen.&#xD;
&#xD;
      Optune® will continue until second disease progression per RANO Criteria or 24 months (the&#xD;
      earlier of the two) unless any of the treatment discontinuation conditions described under&#xD;
      criteria for patient withdrawal or termination are met.&#xD;
&#xD;
      After surgery or biopsy, subjects that would like to participate will be required to submit&#xD;
      samples of their tumor to a lab for testing. The results of this test will be used for&#xD;
      randomization into the trial.&#xD;
&#xD;
      If the subject is assigned to the treatment group that will start Optune® therapy during&#xD;
      radiation therapy, Optune® therapy will begin within 7 days of enrolling in the study and no&#xD;
      later than the first day of RT and TMZ treatment.&#xD;
&#xD;
      After the initial visit, subjects will continue treatment at home, while pursuing normal&#xD;
      daily routines. Subjects are required to use the device for at least 18 hours a day. Short&#xD;
      breaks in treatment for personal hygiene and other personal needs is allowed. Total usage&#xD;
      time will be recorded and provided to the sponsor.&#xD;
&#xD;
      Subjects will be required to return to the clinic every 4 weeks until study participation&#xD;
      ends. Once every 8 weeks until the tumor potentially returns twice, subjects will have a&#xD;
      contrast MRI of the head and neurological exam performed for the first 6 months of the study&#xD;
      and then at least every three months until a total time period of 24 months.Once every 12&#xD;
      weeks until second disease progression, subjects will also fill out a quality of life&#xD;
      questionnaire.&#xD;
&#xD;
      After the second time the tumor returns, subjects will return to the clinic for one final&#xD;
      visit approximately 30 days after the last treatment with Optune®.&#xD;
&#xD;
      After discontinuing Optune® subjects will be contacted once per month by telephone to answer&#xD;
      basic questions about their health status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 8, 2020</start_date>
  <completion_date type="Anticipated">August 2026</completion_date>
  <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Randomly assigned equally to one of two groups:&#xD;
a. Treatment arm I: Patients receive TTFields at 200 kHz to the brain using the Optune® System together with RT and TMZ, followed by maintenance TMZ concomitant with the Optune® treatment.&#xD;
Treatment arm II: Patients receive RT and TMZ alone, followed by maintenance TMZ concomitant with TTFields at 200 kHz to the brain using the Optune®.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>5 years</time_frame>
    <description>Survival will be measured from the time of randomization until date patient is alive.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>5 years</time_frame>
    <description>PFS will be measured from the date of randomization to the date of progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1- and 2-year survival rates</measure>
    <time_frame>5 years</time_frame>
    <description>The analyses will be performed based on estimated proportions of patients who are on study at 12 and 24 months in both arms of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Radiological response (ORR)</measure>
    <time_frame>5 years</time_frame>
    <description>The analyses will be performed based on the RANO criteria, and comparison between the rates of response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Next progression-free survival (PFS2)</measure>
    <time_frame>5 years</time_frame>
    <description>PFS2 will be measured from the time of randomization to second tumor progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival at 6 (PFS6) and 12 months (PFS12)</measure>
    <time_frame>5 years</time_frame>
    <description>The analyses will be estimated proportions of patients who are progression-free at 6 and 12 months in both arms of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity and frequency of adverse events</measure>
    <time_frame>5 years</time_frame>
    <description>The analyses will be performed based on the incidence, severity, frequency of adverse events, and their association with study treatments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pathological changes in resected GBM tumors following study treatments</measure>
    <time_frame>5 years</time_frame>
    <description>Pathological changes in the tumors and also underwent another surgical resection while on the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life EORTC Questionnaire</measure>
    <time_frame>5 years</time_frame>
    <description>The analyses will be assessed using the EORTC QLQ C-30 questionnaire with BN-20 (brain symptom) supplement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dependence of overall survival on TTFields dose at the tumor</measure>
    <time_frame>5 years</time_frame>
    <description>Examining the dependence of overall survival on TTFields dose delivered to the tumor bed will be performed in both the treatment and control arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The NANO scale</measure>
    <time_frame>5 years</time_frame>
    <description>The Neurological assessment in Neuro-Oncology will be assessed using the NANO scale questionnaire and per RANO criteria.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">950</enrollment>
  <condition>Glioblastoma Multiforme</condition>
  <arm_group>
    <arm_group_label>Optune® + RT + TMZ for 6 weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Optune® + RT + TMZ for 6 weeks, followed by Optune® + TMZ until the tumor progresses. Optune treatment is maintained until second disease progression or 24 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RT +TMZ for 6 weeks</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>RT +TMZ for 6 weeks followed by Optune® + TMZ until the tumor progresses. Optune treatment is maintained until second disease progression or 24 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Optune®</intervention_name>
    <description>Optune® is a commercial, portable, battery-operated device intended for continuous home use, which delivers TTFields at a frequency of 200kHz to the brain by means of insulated transducer arrays. The Optune® device produces electric forces intended to disrupt cancer cell division.&#xD;
In treatment arm I, the patient starts Optune® concurrently with RT/TMZ for 6 weeks, followed by Optune® + TMZ until second disease progression.&#xD;
In treatment arm II, the patient starts RT/TMZ for 6 weeks, followed by Optune® + TMZ until second disease progression.&#xD;
The study treatment plan will continue for 24 months, if no tumor progression.</description>
    <arm_group_label>Optune® + RT + TMZ for 6 weeks</arm_group_label>
    <arm_group_label>RT +TMZ for 6 weeks</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed diagnosis of GBM according to WHO classification criteria.&#xD;
&#xD;
          2. Age ≥ 22 years in US and Age ≥ 18 years in Ex-US&#xD;
&#xD;
          3. Recovered from maximal debulking surgery, if applicable (gross total resection,&#xD;
             partial resection, and biopsy-only patients are all acceptable)&#xD;
&#xD;
          4. Planned treatment with RT/TMZ followed by TTFields and maintenance TMZ (150-200 mg/m2&#xD;
             daily x 5 d, q28 days)&#xD;
&#xD;
          5. Karnofsky performance status ≥ 70&#xD;
&#xD;
          6. Life expectancy ≥ least 3 months&#xD;
&#xD;
          7. Participants of childbearing age must use highly effective contraception. An effective&#xD;
             method of birth control is defined as one that results in a failure rate of less than&#xD;
             1% per year when used consistently and correctly. The Investigator must approve the&#xD;
             selected method, and may consult with a gynecologist as needed.&#xD;
&#xD;
          8. All patients must understand and voluntarily sign an informed consent document prior&#xD;
             to any study related assessments/procedures being conducted.&#xD;
&#xD;
          9. Stable or decreasing dose of corticosteroids for the last 7 days prior to&#xD;
             randomization, if applicable.&#xD;
&#xD;
         10. Concomitant RT with TMZ treatment planned to start no later than 8 weeks from surgery&#xD;
&#xD;
         11. Women of childbearing potential must have a negative β-HCG pregnancy test documented&#xD;
             within 14 days prior to registration&#xD;
&#xD;
         12. Is able to have MRI with contrast of the brain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Progressive disease (per investigator's assessment)&#xD;
&#xD;
          2. Infratentorial or leptomeningeal disease&#xD;
&#xD;
          3. Participation in another clinical treatment study during the pre-treatment and/or the&#xD;
             treatment phase of the study&#xD;
&#xD;
          4. Pregnancy or breast-feeding.&#xD;
&#xD;
          5. Significant co-morbidities at baseline which would preclude maintenance RT or TMZ&#xD;
             treatment, as determined by the investigator:&#xD;
&#xD;
               1. Thrombocytopenia (platelet count &lt; 100 x 103/μL)&#xD;
&#xD;
               2. Neutropenia (absolute neutrophil count &lt; 1.5 x 103/μL)&#xD;
&#xD;
               3. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)&#xD;
&#xD;
               4. Significant liver function impairment - AST or ALT &gt; 3 times the upper limit of&#xD;
                  normal&#xD;
&#xD;
               5. Total bilirubin &gt; 1.5 x upper limit of normal&#xD;
&#xD;
               6. Significant renal impairment (serum creatinine &gt; 1.7 mg/dL, or &gt; 150 µmol/l)&#xD;
&#xD;
               7. History of any psychiatric condition that might impair patient's ability to&#xD;
                  understand or comply with the requirements of the study or to provide consent&#xD;
&#xD;
          6. Implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic&#xD;
             devices in the brain, or documented clinically significant arrhythmias.&#xD;
&#xD;
          7. Evidence of increased intracranial pressure (midline shift &gt; 5mm, clinically&#xD;
             significant papilledema, vomiting and nausea or reduced level of consciousness)&#xD;
&#xD;
          8. History of hypersensitivity reaction to TMZ or a history of hypersensitivity to DTIC.&#xD;
&#xD;
          9. Any other cytotoxic or biologic anti-tumor therapy received prior to enrollment will&#xD;
             be considered exclusion.&#xD;
&#xD;
         10. Admitted to an institution by administrative or court order.&#xD;
&#xD;
         11. Known allergies to medical adhesives or hydrogel&#xD;
&#xD;
         12. A skull defect (such as, missing bone with no replacement)&#xD;
&#xD;
         13. Prior radiation treatment to the brain for the treatment of GBM&#xD;
&#xD;
         14. Any serious surgical/post-operative condition that may risk the patient according to&#xD;
             the investigator&#xD;
&#xD;
         15. Standard TTFields exclusion criteria include&#xD;
&#xD;
               1. Active implanted medical devices&#xD;
&#xD;
               2. Bullet fragments&#xD;
&#xD;
               3. Skull defects&#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_contact>
    <last_name>Doron Manzur, MD</last_name>
    <phone>+1 603 206 2337</phone>
    <email>clinicaltrials@novocure.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Doria Kaluza</last_name>
    <phone>+1 603 206 2337</phone>
    <email>clinicaltrials@novocure.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Grandview Cancer Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35243</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer De Los Santos, MD</last_name>
      <phone>205-971-1800</phone>
      <email>jennifer.delossantos@grandviewhealth.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Banner MD Anderson Cancer Center</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Traci Purifoy-Glaspie</last_name>
      <email>Traci.Purifoy-Glaspie@bannerhealth.com</email>
    </contact>
    <contact_backup>
      <email>Terence.Roberts@bannerhealth.com</email>
    </contact_backup>
    <investigator>
      <last_name>Terence Roberts</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic- Arizona</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Arizona Cancer Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85719</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Baldasarre Stea, MD</last_name>
      <phone>520-626-2218</phone>
      <email>bstea@email.arizona.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Highlands Oncology Group</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72762</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thaddeus J Beck, MD</last_name>
      <phone>479-587-1700</phone>
      <email>tbeck@hogonc.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>City of Hope National Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jana Portnow, MD</last_name>
      <phone>626-218-3793</phone>
      <email>jportnow@coh.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>TRIO - St. Jude Heritage Healthcare/St. Jude Medical Center</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Park, MD</last_name>
      <phone>714-446-5900</phone>
      <email>david.park@stjoe.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of California at San Diego - Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Piccioni, MD</last_name>
      <phone>858-534-0254</phone>
      <email>dpiccioni@ucsd.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Norris Comprehensive Cancer Center at USC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason Ye, MD</last_name>
      <phone>323-865-3052</phone>
      <email>jason.ye@med.usc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cedars - Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90266</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jethro Hu, MD</last_name>
      <phone>310-248-7141</phone>
      <email>jethro.hu@cshs.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Providence St. Joseph Medical Center and The Roy and Patricia Disney Family Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>91505</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Naveed Wagle, MD</last_name>
      <phone>323-865-0721</phone>
      <email>naveed.wagle@jwci.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hoag Memorial Hospital - Hoag Cancer Center</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jose Carrillo, MD</last_name>
      <phone>949-764-4430</phone>
      <email>jose.carrillo@hoag.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>St. Joseph Hospital of Orange</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joscelyn Green</last_name>
      <phone>714-734-6220</phone>
      <email>joscelyn.green@stjoe.org</email>
    </contact>
    <contact_backup>
      <last_name>Rachelle Alquitela</last_name>
      <phone>(714) 734-6200</phone>
      <email>rachelle.alquitela@stjoe.org</email>
    </contact_backup>
    <investigator>
      <last_name>Lars Anker</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of California - Irvine/UCI Medical Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiao Tang Kong, MD</last_name>
      <phone>714-456-7214</phone>
      <email>xkong@hs.uci.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Stanford University Cancer Institute</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94303</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Seema Nagpal, MD</last_name>
      <phone>650-725-8630</phone>
      <email>snagpal@stanford.edu</email>
    </contact>
    <investigator>
      <last_name>Seema Nagpal</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sharp Memorial Hospital - X-Ray Medical Group Radiation Oncology</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Siavash Jabbari, MD</last_name>
      <phone>619-644-4500</phone>
      <email>siavashjabbari@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>John Wayne Cancer Institute at St. John's Health Center</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Akanksha Sharma, MD</last_name>
      <phone>409-256-6874</phone>
      <email>akanksha.sharma@providence.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Colorado Cancer Center Anschutz</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Denise Damek, MD</last_name>
      <phone>303-724-2184</phone>
      <email>denise.damek@cuanschutz.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>HCA Research Institute - Blue Sky Neurology - Denver</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hartford Healthcare Medical Group - Hartford Hospital The Gray Cancer Center</name>
      <address>
        <city>New London</city>
        <state>Connecticut</state>
        <zip>06320</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexis Demopolous, MD</last_name>
      <phone>860-696-5169</phone>
      <email>alexis.demopolous@hhchealth.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lynn Cancer Institute, Marcus Neuroscience Institute</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Baptist Health - Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Cavaliere, MD</last_name>
      <phone>904-202-7300</phone>
      <email>robert.cavaliere@bmcjax.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Peterson, MD</last_name>
      <phone>904-717-0207</phone>
      <email>peterson.jennifer2@mayo.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AdventHealth</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sherif Makar, MD</last_name>
      <phone>321-906-8712</phone>
      <email>sherif.makar.md@adventhealth.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Orlando Health UF Health Cancer Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicholas Avgeropoulos, MD</last_name>
      <phone>321-841-7218</phone>
      <email>Nicholas.Avgeropoulos@OrlandoHealth.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center and Research Institute, Inc</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Yu, MD</last_name>
      <phone>813-745-8741</phone>
      <email>michael.yu@moffitt.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Piedmont Healthcare Brain Tumor Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Emory Clinic - Emory Healthcare - Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hui-Kuo Shu, MD</last_name>
      <phone>404-778-3473</phone>
      <email>hgshu@emory.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Northside Hospital, Inc.</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gina Volas-Redd, MD</last_name>
      <phone>770-590-8311</phone>
      <email>gena.volas@gacancer.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Parkview Cancer Institute - Fort Wayne Radiation Oncology Associates</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brian Chang, MD</last_name>
      <phone>260-266-9100</phone>
      <email>bchang02@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The University of Kansas Cancer Center</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shalina Gupta-Burt, MD</last_name>
      <phone>785-295-8008</phone>
      <email>sguptaburt@kumc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Louisville - James Graham Brown Cancer Center</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shiao Woo, MD</last_name>
      <phone>502-561-2700</phone>
      <email>shiao.woo@louisville.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Norton Cancer Institute</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kaylyn Sinicrope, MD</last_name>
      <phone>541-968-7896</phone>
      <email>kaylyn.sinicrope@nortonhealthcare.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>LSU Health Sciences Center, New Orleans</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70072</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Ochsner Health System</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121-2429</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marcus Ware, MD</last_name>
      <phone>504-842-4000</phone>
      <email>mware@ochsner.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Maine Medical Partners Neurology - Neurosurgery &amp; Spine Associates</name>
      <address>
        <city>South Portland</city>
        <state>Maine</state>
        <zip>04106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christine Lu-Emerson, MD</last_name>
      <phone>207-883-1414</phone>
      <email>cluemerson@mmc.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>John Hopkins School of Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lawrence Kleinberg, MD</last_name>
      <phone>410-614-2597</phone>
      <email>kleinla@jhmi.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suriya Jeyapalan, MD</last_name>
      <phone>617-636-2694</phone>
      <email>sjeyapalan@tuftsmedicalcenter.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts Chan Medical School</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alex Agrillo</last_name>
      <phone>774-455-4456</phone>
      <email>alexandra.agrillo@umassmed.edu</email>
    </contact>
    <investigator>
      <last_name>David Cachia</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Michigan Comprehensive Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Abbott Northwestern Hospital - Givens Brain Tumor Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Wasilewski, MD</last_name>
      <phone>612-863-3732</phone>
      <email>Andrea.Wasilewski@allina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Minnesota Health Clinics and Surgery Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lynette Harper</last_name>
      <email>lharper@umc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Jennifer Barnes</last_name>
      <email>jbarnes@umc.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Mark Anderson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Missouri - Ellis Fischel Cancer Center</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gregg Biedermann, MD</last_name>
      <phone>573-884-8264</phone>
      <email>biedermanng@health.missouri.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Health Midwest Ventures Group, Inc - Sarah Cannon HCA Midwest Brain and Spine</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64132</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Chan, MD</last_name>
      <phone>603-650-5104</phone>
      <email>amy.m.chan@hitchcock.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>JFK Neuroscience Institute, HMH JFK University Medical Center</name>
      <address>
        <city>Edison</city>
        <state>New Jersey</state>
        <zip>08820</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joseph Landolfi, MD</last_name>
      <phone>732-321-7010</phone>
      <email>Joseph.Landolfi@hackensackmeridian.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center - John Theurer Cancer Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Northwell Health System Brain Tumor Center</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anuj Goenka, MD</last_name>
      <phone>516-321-3000</phone>
      <email>agoenka@northwell.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>NYU Langone - Laura &amp; Issac Perimutter Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erik Sulman, MD</last_name>
      <phone>646-501-6153</phone>
      <email>erik.sulman@nyulangone.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mount Sinai - Icahn School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Disha Jain</last_name>
      <email>Disha.jain@mssm.edu</email>
    </contact>
    <contact_backup>
      <phone>212-824-8579</phone>
      <email>Lyndon.kim@mssm.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Lyndon Kim</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>New York Presbyterian - Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fabio Iwamoto, MD</last_name>
      <phone>212-342-0571</phone>
      <email>fi2146@cumc.columbia.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nimish Mohile, MD</last_name>
      <phone>585-275-5823</phone>
      <email>nimish_mohile@urmc.rochester.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>SUNY Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ruham Alshiekh Nasany</last_name>
      <phone>315-464-3510</phone>
      <email>nasanyr@upstate.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of North Carolina Brain Tumor Program - UNC Lineberger Comprehensive Cancer Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Colette Shen, MD</last_name>
      <phone>984-974-0400</phone>
      <email>colette_shen@med.unc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Novant Health Cancer Institute Radiation Oncology</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Scott L McGinnis, MD</last_name>
      <phone>704-316-6630</phone>
      <email>lsmcginnis@novanthealth.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vidant Medical Center</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jasmin Jo, MD</last_name>
      <phone>252-816-2273</phone>
      <email>Jasmin.Jo@vidanthealth.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Forsyth Medical Center-Novant Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Volker Stieber, MD</last_name>
      <phone>336-718-5810</phone>
      <email>vwstieber@novanthealth.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Comprehensive Cancer Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Glenn Lesser, MD</last_name>
      <phone>336-716-9527</phone>
      <email>glesser@wakehealth.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati Cancer Institute</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kyle Wang, MD</last_name>
      <phone>603-244-9889</phone>
      <email>wang2kl@ucmail.uc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The James Cancer Hospital and Solove Research Institute - Arthur G James Cancer Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Piere Giglio, MD</last_name>
      <phone>614-293-4448</phone>
      <email>pierre.giglio@osumc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University (OHSU)</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Minger</last_name>
      <phone>503-494-8756</phone>
      <email>mingerj@ohsu.edu</email>
    </contact>
    <contact_backup>
      <email>murphbl@ohsu.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Blair Murphy, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Geisinger Health System</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Steven Brem, MD</last_name>
      <phone>215-662-3487</phone>
      <email>steven.brem@uphs.upenn.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wenyin Shi, MD</last_name>
      <phone>215-955-6702</phone>
      <email>wenyin.shi@jefferson.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Allegheny Health Network Cancer Institute</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Helen Andreko</last_name>
      <phone>412-359-3400</phone>
      <email>helen.andreko@ahn.org</email>
    </contact>
    <contact_backup>
      <last_name>Paul Woods</last_name>
      <email>Paul.Woods@AHN.ORG</email>
    </contact_backup>
    <investigator>
      <last_name>Zachary Horne, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Frank Lieberman, MD</last_name>
      <phone>412-648-6507</phone>
      <email>liebermanf@upmc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Steven Toms, MD</last_name>
      <phone>401-793-9175</phone>
      <email>steven.toms@lifespan.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>MUSC Radiation Oncology Brain &amp; Spine Tumor Program</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Scott Lindhorst, MD</last_name>
      <phone>843-792-9016</phone>
      <email>lindhors@musc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>SCRI - Tennessee Oncology</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Graham, MD</last_name>
      <phone>434-409-7128</phone>
      <email>rmgraham@tnonc.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>West Cancer Center - Germantown</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthew Ballo, MD</last_name>
      <phone>901-683-0055</phone>
      <email>mballo@westclinic.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>SCRI - Tennessee Oncology</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Spigel, MD</last_name>
      <phone>615-524-4016</phone>
      <email>colleen.shaw@sarahcannon.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Texas Oncology Midtown - Austin Brain Tumor Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew Brenner, MD</last_name>
      <phone>512-421-4100</phone>
      <email>andrew.brenner@usoncology.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Baylor Charles A. Sammons Cancer Center - Baylor University Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karen Fink, MD</last_name>
      <phone>214-820-8690</phone>
      <email>karen.fink@bswhealth.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>John Peter Smith Health Network - JPS Cancer Center</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emmanuel Mantilla, MD</last_name>
      <phone>817-702-8300</phone>
      <email>emantill@jpshealth.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ivo Tremont, MD</last_name>
      <phone>713-441-3831</phone>
      <email>itremont@houstonmethodist.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>UT Health Mischer Neuroscience - Memorial Herman - UT Neurosciences</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jay-Jinguang Zhu, MD</last_name>
      <phone>832-799-7362</phone>
      <email>jay.jiguang.zhu@uth.tmc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>San Antonio Cancer Institute</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Baylor Scott &amp; White Medical Center</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne Tann, MD</last_name>
      <phone>254-724-2417</phone>
      <email>anne.tann@bswhealth.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The University of Vermont Medical Center - University of Vermont Cancer Center</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alissa Thomas, MD</last_name>
      <phone>802-656-8982</phone>
      <email>alissa.thomas@uvmhealth.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Massey Cancer Center - VCU Medical Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Swedish Health Services</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kester Phillips, MD</last_name>
      <phone>206-320-2300</phone>
      <email>Kester.phillips@swedish.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>UW Medical Center - Alvord Brain Tumor Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tresa McGranahan, MD</last_name>
      <phone>206-520-5000</phone>
      <email>tmcgranahan@uwmedicine.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>West Virginia University Cancer Institute</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sonikpreet Aulakh, MD</last_name>
      <phone>248-463-8181</phone>
      <email>sonikpreet.aulakh@hsc.wvu.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Innsbruck University Hospital</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kepler University Hospital</name>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Hospital Salzburg</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Erasme</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Olivier De Witte, Prof</last_name>
      <phone>0032 2 555 3357</phone>
      <email>olivier.de.witte@erasme.ulb.ac.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Liege - Sart Tilman</name>
      <address>
        <city>Liège</city>
        <zip>B35, 4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre Freres, Dr.</last_name>
      <phone>0032 4 242 52 00</phone>
      <email>pfreres@chuliege.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital Cancer Centre</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Garth Nicholas, Prof</last_name>
      <phone>(613) 737-7700</phone>
      <email>gnicholas@toh.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Warren Mason, Prof</last_name>
      <phone>416-946-2249</phone>
      <email>warren.mason@uhn.on.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Research Institute - Odette Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jay Detsky, Dr.</last_name>
      <phone>416.480.4806</phone>
      <email>jay.detsky@sunnybrook.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHUM Centre de Recherche</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2X1R9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mom Phat, Prof</last_name>
      <phone>(514) 890-8000</phone>
      <email>mom.phat.chum@ssss.gouv.qc.ca</email>
    </contact>
    <contact_backup>
      <email>sarah.lapointe.med@ssss.gouv.qc.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Sarah Lapointe</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universite de Sherbrooke - Sherbrooke Centre Hospitalier Universita</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Mathieu, Prof</last_name>
      <phone>(819) 564-5251</phone>
      <email>david.mathieu@usherbrooke.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Masaryk Memorial Cancer Institute</name>
      <address>
        <city>Brno</city>
        <zip>656 53</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Hospital Plzeň</name>
      <address>
        <city>Pilsen</city>
        <zip>305 99</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Na Homolce Hospital</name>
      <address>
        <city>Prague</city>
        <zip>150 30</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institut de cancérologie de l'Ouest</name>
      <address>
        <city>Angers</city>
        <zip>49055</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Pierre Wertheimer Hospital</name>
      <address>
        <city>Bron</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital la Timone</name>
      <address>
        <city>Marseille</city>
        <zip>13305</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Hospital Nice</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Pitié-Salpêtrière University Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institut de cancérologie de l'Ouest</name>
      <address>
        <city>Saint Herblain</city>
        <zip>44800</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Institute Cancer Toulouse Oncopole</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gustave Roussy Institute</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Charité Campus Virchow Clinic</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>David Kaul, Dr.</last_name>
      <phone>0049 30 450 527 112</phone>
      <email>david.kaul@charite.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Essen</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Glas, Prof</last_name>
      <phone>0049 201 723 2461</phone>
      <email>martin.glas@uk-essen.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Medical Center Freiburg</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carmen Meffle</last_name>
      <phone>+49 761 270 95880</phone>
      <email>carmen.meffle@uniklinik-freiburg.de</email>
    </contact>
    <investigator>
      <last_name>Anca-Ligia Grosu, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claudia Göpel, Dr.</last_name>
      <phone>+49 (0) 341 / 97 18214</phone>
      <email>claudia.goepel@medizin.uni-leipzig.de</email>
    </contact>
    <investigator>
      <last_name>Clemens Seidel, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rechts der Isar Hospital</name>
      <address>
        <city>Munich</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jan Stefan Kirschke, Prof</last_name>
      <phone>+49 89 4140 4501</phone>
      <email>jan.kirschke@tum.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Tübingen</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Susanne Luginsland</last_name>
      <phone>0049 7071 29-83269</phone>
      <email>tabatabai.office@med.uni-tuebingen.de</email>
    </contact>
    <investigator>
      <last_name>Tabatabai Ghazaleh, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rambam Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liat Rapaport</last_name>
      <phone>+972 04 7776731</phone>
      <email>O_trials@rmc.gov.il</email>
    </contact>
    <investigator>
      <last_name>Tzahala Tzuk-Shina, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center - Ein Kerem</name>
      <address>
        <city>Jerusalem</city>
        <zip>9112001</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof</last_name>
    </contact>
    <contact_backup>
      <last_name>Anat Mordechai</last_name>
      <phone>972-2-6778719</phone>
      <email>matan29@hadassah.org.il</email>
    </contact_backup>
    <investigator>
      <last_name>Alexander Lossos, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petah Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shlomit Yust-Katz, Dr.</last_name>
      <phone>00(972) 3937-8077</phone>
      <email>shlomit2@clalit.org.il</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alisa Taliansky, Dr.</last_name>
      <phone>+972 52 46 47 494</phone>
      <email>alisa.talianski@sheba.health.gov.il</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carmit Ben Harosh</last_name>
      <phone>972-3-6974397</phone>
      <email>Carmitbh@tlvmc.gov.il</email>
    </contact>
    <investigator>
      <last_name>Jonathan Roth, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>060-8648</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hidefumi Aoyama</last_name>
      <phone>+81 11-706-5977</phone>
      <email>h-aoyama2019@med.hokudai.ac.jp</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kanazawa University Hospital</name>
      <address>
        <city>Kanazawa-shi</city>
        <state>Ishikawa-Ken</state>
        <zip>920-8641</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mitsutoshi Nakada</last_name>
      <phone>+81 76-265-2383</phone>
      <email>mnakada@med.kanazawa-u.ac.jp</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Saitama Medical University International Medical Center</name>
      <address>
        <city>Hidaka-shi</city>
        <state>Saitama-Ken</state>
        <zip>350-1298</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kazuhiko Mishima</last_name>
      <phone>+81 42-984-4177</phone>
      <email>kmishima@saitama-med.ac.jp</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kyorin University Hospital</name>
      <address>
        <city>Mitaka-shi</city>
        <state>Tokyo-To</state>
        <zip>181-8611</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Motoo Nagane</last_name>
      <phone>+81 422-47-5511</phone>
      <email>mnagane@ks.kyorin-u.ac.jp</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tokyo Women's Medical University Hospital</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo-To</state>
        <zip>162-8666</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shunsuke Tsuzuki</last_name>
      <phone>+81 11-706-5977</phone>
      <email>tsuzuki.shunsuke@twmu.ac.jp</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lausanne University Hospital</name>
      <address>
        <city>Lausanne</city>
        <zip>CH-1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreas Hottinger, Dr.</last_name>
      <phone>0041 21 314 46 90</phone>
      <email>Andreas.Hottinger@chuv.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick Roth, Prof.</last_name>
      <phone>00(41) 4425-55511</phone>
      <email>patrick.roth@usz.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clatterbridge Cancer Centre</name>
      <address>
        <city>Liverpool</city>
        <zip>L7 8YA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shaveta Mehta</last_name>
      <phone>+44 0151 556 5054</phone>
      <email>shaveta.mehta1@nhs.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Guy's Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christopher Bayliss</last_name>
      <email>brainresearchteam@gstt.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Lucy Brazil, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Charing Cross Hospital</name>
      <address>
        <city>London</city>
        <zip>W6 8RF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthew Williams</last_name>
      <phone>+44 203313 0303</phone>
      <email>matthew.williams@imperial.ac.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elvira Amaro</last_name>
      <phone>0115 9691169</phone>
      <phone_ext>74690</phone_ext>
      <email>Elvira.Amaro@nuh.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Karen Foweraker</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Preston Hospital</name>
      <address>
        <city>Preston</city>
        <zip>PR29HT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Issac Phang, Dr.</last_name>
      <phone>(+44) 01772 522575</phone>
      <email>isaac.phang@lthtr.nhs.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Japan</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Australia</country>
  </removed_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GBM</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/NCT04471844
org study id: TRIDENT EF-32
nct id: NCT04471844
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
To test the effectiveness and safety of Optune® given concomitantly with radiation therapy
      (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy
      and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued
      following radiation therapy.
Optune® is a medical device that has been approved for the treatment of recurrent and newly
      diagnosed glioblastoma (GBM) by the Food and Drug Administration (FDA) in the United States.
      Optune® has obtained a CE mark in Europe for recurrent and newly diagnosed GBM.

      The current standard of care for GBM includes the addition of Optune® to maintenance
      temozolomide (TMZ), following the completion of radiation therapy (RT).

      The purpose of the current study is to test if the earlier introduction of Optune®, at the
      time of radiation therapy (which is given together with temozolomide), improves clinical
      outcomes compared to the standard of care.

      The study will randomize 950 subjects equally to one of two treatment arms:

        1. Treatment arm I: Patients receive TTFields at 200 kHz to the brain using the Optune®
           System together with RT and TMZ, followed by maintenance TMZ concomitant with the
           Optune® treatment.

        2. Treatment arm II: Patients receive RT and TMZ alone, followed by maintenance TMZ
           concomitant with TTFields at 200 kHz to the brain using the Optune®.

      All patients are to receive standard RT and TMZ treatment followed by maintenance TMZ
      chemotherapy and Optune® according to the current standard of care regimen.

      Optune® will continue until second disease progression per RANO Criteria or 24 months (the
      earlier of the two) unless any of the treatment discontinuation conditions described under
      criteria for patient withdrawal or termination are met.

      After surgery or biopsy, subjects that would like to participate will be required to submit
      samples of their tumor to a lab for testing. The results of this test will be used for
      randomization into the trial.

      If the subject is assigned to the treatment group that will start Optune® therapy during
      radiation therapy, Optune® therapy will begin within 7 days of enrolling in the study and no
      later than the first day of RT and TMZ treatment.

      After the initial visit, subjects will continue treatment at home, while pursuing normal
      daily routines. Subjects are required to use the device for at least 18 hours a day. Short
      breaks in treatment for personal hygiene and other personal needs is allowed. Total usage
      time will be recorded and provided to the sponsor.

      Subjects will be required to return to the clinic every 4 weeks until study participation
      ends. Once every 8 weeks until the tumor potentially returns twice, subjects will have a
      contrast MRI of the head and neurological exam performed for the first 6 months of the study
      and then at least every three months until a total time period of 24 months.Once every 12
      weeks until second disease progression, subjects will also fill out a quality of life
      questionnaire.

      After the second time the tumor returns, subjects will return to the clinic for one final
      visit approximately 30 days after the last treatment with Optune®.

      After discontinuing Optune® subjects will be contacted once per month by telephone to answer
      basic questions about their health status.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomly assigned equally to one of two groups:
a. Treatment arm I: Patients receive TTFields at 200 kHz to the brain using the Optune® System together with RT and TMZ, followed by maintenance TMZ concomitant with the Optune® treatment.
Treatment arm II: Patients receive RT and TMZ alone, followed by maintenance TMZ concomitant with TTFields at 200 kHz to the brain using the Optune®.
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival (OS)
time frame: 5 years
description: Survival will be measured from the time of randomization until date patient is alive.
measure: Progression Free Survival (PFS)
time frame: 5 years
description: PFS will be measured from the date of randomization to the date of progression.
measure: 1- and 2-year survival rates
time frame: 5 years
description: The analyses will be performed based on estimated proportions of patients who are on study at 12 and 24 months in both arms of the study.
measure: Overall Radiological response (ORR)
time frame: 5 years
description: The analyses will be performed based on the RANO criteria, and comparison between the rates of response.
measure: Next progression-free survival (PFS2)
time frame: 5 years
description: PFS2 will be measured from the time of randomization to second tumor progression.
measure: Progression-free survival at 6 (PFS6) and 12 months (PFS12)
time frame: 5 years
description: The analyses will be estimated proportions of patients who are progression-free at 6 and 12 months in both arms of the study.
measure: Severity and frequency of adverse events
time frame: 5 years
description: The analyses will be performed based on the incidence, severity, frequency of adverse events, and their association with study treatments.
measure: Pathological changes in resected GBM tumors following study treatments
time frame: 5 years
description: Pathological changes in the tumors and also underwent another surgical resection while on the study.
measure: Quality of Life EORTC Questionnaire
time frame: 5 years
description: The analyses will be assessed using the EORTC QLQ C-30 questionnaire with BN-20 (brain symptom) supplement.
measure: Dependence of overall survival on TTFields dose at the tumor
time frame: 5 years
description: Examining the dependence of overall survival on TTFields dose delivered to the tumor bed will be performed in both the treatment and control arms.
measure: The NANO scale
time frame: 5 years
description: The Neurological assessment in Neuro-Oncology will be assessed using the NANO scale questionnaire and per RANO criteria.
arm group label: Optune® + RT + TMZ for 6 weeks
arm group type: Experimental
description: Optune® + RT + TMZ for 6 weeks, followed by Optune® + TMZ until the tumor progresses. Optune treatment is maintained until second disease progression or 24 months.
arm group label: RT +TMZ for 6 weeks
arm group type: Active Comparator
description: RT +TMZ for 6 weeks followed by Optune® + TMZ until the tumor progresses. Optune treatment is maintained until second disease progression or 24 months.
intervention type: Device
intervention name: Optune®
description: Optune® is a commercial, portable, battery-operated device intended for continuous home use, which delivers TTFields at a frequency of 200kHz to the brain by means of insulated transducer arrays. The Optune® device produces electric forces intended to disrupt cancer cell division.
In treatment arm I, the patient starts Optune® concurrently with RT/TMZ for 6 weeks, followed by Optune® + TMZ until second disease progression.
In treatment arm II, the patient starts RT/TMZ for 6 weeks, followed by Optune® + TMZ until second disease progression.
The study treatment plan will continue for 24 months, if no tumor progression.
arm group label: Optune® + RT + TMZ for 6 weeks
arm group label: RT +TMZ for 6 weeks
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Doron Manzur, MD
phone: +1 603 206 2337
email: clinicaltrials@novocure.com
last name: Doria Kaluza
phone: +1 603 206 2337
email: clinicaltrials@novocure.com
facility: 
status: Recruiting
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status: Active, not recruiting
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status: Not yet recruiting
contact: 
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facility: 
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contact: 
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contact: 
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contact: 
country: Austria
country: Belgium
country: Canada
country: Czechia
country: France
country: Germany
country: Israel
country: Japan
country: Switzerland
country: United Kingdom
country: United States
country: Australia
responsible party type: Sponsor
mesh term: Glioblastoma