<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/NCT03232424</url>
  </required_header>
  <id_info>
    <org_study_id>Pro2017-0087</org_study_id>
    <nct_id>NCT03232424</nct_id>
  </id_info>
  <brief_title>NovoTTF-200A and Temozolomide Chemoradiation for Newly Diagnosed Glioblastoma</brief_title>
  <official_title>Pilot Study of Concomitant NovoTTF-200A and Temozolomide Chemoradiation for Newly Diagnosed Glioblastoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hackensack Meridian Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NovoCure Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hackensack Meridian Health</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>
      This study is a prospective single arm trial designed to study the safety, feasibility and&#xD;
      preliminary efficacy of a medical device, NovoTTF-200A used concomitantly with standard&#xD;
      adjuvant treatment for newly diagnosed glioblastoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, single arm, non-randomized, open label pilot trial will enroll ten patients&#xD;
      with histologically-confirmed newly diagnosed GBM who meet all eligibility criteria. Patients&#xD;
      will be recruited to the study by the principal investigator (PI) or one of the&#xD;
      co-investigators (CI) at one institution, Hackensack University Medical Center. Accrual is&#xD;
      expected to continue for 18 months.&#xD;
&#xD;
      The protocol has a planned enrollment of 10 patients. Should patients discontinue treatment&#xD;
      on protocol for reasons unrelated to toxicity (e.g. lost to follow-up, withdrawal of&#xD;
      consent), additional patient (s) may be enrolled to complete enrollment.&#xD;
&#xD;
      Following maximal debulking surgery, patients will undergo a gadolinium enhanced brain MRI&#xD;
      within 72 hours and a screening visit 2 to 4 weeks following surgery. Extent of resection&#xD;
      will be recorded as biopsy, partial resection or gross-total resection based upon residual&#xD;
      enhancing tumor on post-operative MRI.The day prior to XRT start, patients will have a clinic&#xD;
      visit for training and application of the NovoTTF-200A device. During this visit, the patient&#xD;
      will be educated regarding general use and maintenance of the device, with a particular focus&#xD;
      upon strategies to prevent, identify and manage dermatologic adverse events (dAE).&#xD;
      Temozolomide will be dosed nightly during XRT as per standard of care, and NovoTTF-200A will&#xD;
      be worn continuously, removed during XRT and replaced as soon as possible thereafter.&#xD;
&#xD;
      During XRT and for 12 weeks to follow, the patient will have study visits at regular&#xD;
      intervals (TAB A) for a physical examination and to assess toxicity and device compliance.&#xD;
      Visits outlined in TAB A are in addition to weekly visits during radiotherapy with the&#xD;
      treating radiation oncologist. MRI will be obtained at 4 weeks (+/-7 days) and 12 weeks (+/-7&#xD;
      days) following completion of XRT, and maintenance temozolomide will recommence in 5/28 day&#xD;
      cycles as per standard of care. Objective response will be assessed as defined by the&#xD;
      Response Assessment in Neuro-Oncology (RANO) criteria (TAB C) by the treating physician and&#xD;
      confirmed by a second investigator.&#xD;
&#xD;
      In the case of suspected pseudoprogression, continued treatment and subsequent evaluations&#xD;
      will help clarify whether it is true progression. Patients may continue treatment at the&#xD;
      discretion of the investigator. If subsequent evaluations suggest that the tumor has in fact&#xD;
      progressed, the date of progression will reflex to the date when the issue was first raised.&#xD;
      However, if subsequent evaluations demonstrate improvement without change in therapy, the&#xD;
      initial tumor increase may be considered pseudoprogression and response may be recorded as&#xD;
      not evaluable for that time point. In the case of clinical progression, an unscheduled MRI&#xD;
      will be obtained within 1 week of the investigator becoming aware of the clinical&#xD;
      progression. No additional MRIs will be required after progression.&#xD;
&#xD;
      Temozolomide and NovoTTF-200A will continue until the final study visit, or until disease&#xD;
      progression or unacceptable toxicity. Thereafter, temozolomide, MRI and response assessments&#xD;
      will continue as per standard of care. Following the final study visit, the patient will be&#xD;
      followed at a minimum of every two months for survival, either by phone or in person. If the&#xD;
      patient is free of unacceptable toxicity attributable to NovoTTF-200A, they will be offered&#xD;
      the opportunity to continue the device at no financial cost, but without obligation to do so.&#xD;
&#xD;
      Unacceptable toxicity includes the occurrence of device related serious adverse events or&#xD;
      clinical and functional deterioration considered by the investigator to be prohibitive of&#xD;
      continuing treatment. Treatment with the NovoTTF-200A device does not need to be terminated&#xD;
      in the case of temozolomide toxicity.&#xD;
&#xD;
      The primary endpoint will be safety and tolerability of combined modality treatment with&#xD;
      radiotherapy, temozolomide and NovoTTF-200A, based upon the incidence and severity of adverse&#xD;
      events. Secondary endpoints will be overall survival, progression free survival and quality&#xD;
      of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 26, 2017</start_date>
  <completion_date type="Actual">December 7, 2022</completion_date>
  <primary_completion_date type="Actual">December 7, 2022</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Prospective, single arm, non-randomized, open label pilot</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>24 months</time_frame>
    <description>Safety and tolerability of combined modality treatment with radiotherapy, temozolomide and NovoTTF-200A based upon the incidence and severity of adverse events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival time</measure>
    <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months</time_frame>
    <description>Assessed from NovoTTF-200A start date to date of death of any cause. Patients will be censored at the time that they are last known to be alive (if withdrawn or lost to follow-up).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival at 6 months</measure>
    <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months</time_frame>
    <description>Assessed from NovoTTF-200A start date to the date of the first observation of clinical or radiographic disease progression or death due to any cause. Patients will be censored at the time they are last known to be alive and progression free (if withdrawn or lost to follow-up).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30)</measure>
    <time_frame>24 months</time_frame>
    <description>Change from baseline at each measure will be calculated for each subscale domain and symptom scale in the questionnaire. The QLQ-C30 incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. The response scale to each question ranges from 1 (Not at All) to 4 (Very Much). For each subscale domain and symptom scale, the change from baseline will summarized as mean (SD) or median (interquartile range), as appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed using a European Organization for Research and Treatment of Cancer (EORTC) Brain Cancer questionnaire (BN20)</measure>
    <time_frame>24 months</time_frame>
    <description>Change from baseline at each measure will be calculated for each subscale domain and symptom scale in the questionnaire. The questionnaire includes 20 items assessing future uncertainty, visual disorder, motor dysfunction, communication deficit and other disease symptoms (e.g. headaches and seizures) and treatment toxicities (e.g. hair loss). The response scale to each question ranges from 1 (Not at All) to 4 (Very Much). For each subscale domain and symptom scale, the change from baseline will summarized as mean (SD) or median (interquartile range), as appropriate.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Glioblastoma, Adult</condition>
  <arm_group>
    <arm_group_label>NovoTTF-200A + Temozolomide Chemoradiation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NovoTTF-200A, concomitant with radiotherapy and temozolomide, as front-line therapy for glioblastoma</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NovoTTF-200A</intervention_name>
    <description>Begins the day prior to radiotherapy start and continues until the end of temozolomide maintenance cycle #2 or until evidence of disease progression or unacceptable toxicity.&#xD;
Arrays are removed immediately prior to radiotherapy and replaced immediately thereafter.</description>
    <arm_group_label>NovoTTF-200A + Temozolomide Chemoradiation</arm_group_label>
    <other_name>Optune</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Temozolomide</intervention_name>
    <description>Concomitant phase:&#xD;
75 mg/m2 per day for 42 days concomitant with radiotherapy.&#xD;
Begins 1 day prior to XRT start.&#xD;
Maintenance phase:&#xD;
Begins 4 weeks after concomitant phase completion (+/- 1 week).&#xD;
Each cycle is 28 days (5 days of drug treatment followed by 23 days without).&#xD;
Cycle 1: 150 mg/m2 once daily for the first 5 days of each treatment cycle.&#xD;
Subsequent cycles: daily dose increased to 200 mg/m2, if the CTC non-hematologic toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/L, and the platelet count is ≥ 100 x 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.</description>
    <arm_group_label>NovoTTF-200A + Temozolomide Chemoradiation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>3D conformal or intensity modulated radiation therapy (IMRT)</intervention_name>
    <description>Radiotherapy will commence 4 weeks after the definitive surgical procedure (+/- 1 week), to a total dose of 54.0 - 60.0 Gy, delivered in 1.8 - 2.0 Gy fractions over 6 - 7 weeks. XRT target volumes will be determined utilizing all available imaging studies that best delineate extent of disease. Fusion image registration for treatment planning will be utilized as possible. Either 3D conformal or intensity modulated radiation therapy (IMRT) will be utilized.</description>
    <arm_group_label>NovoTTF-200A + Temozolomide Chemoradiation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed GBM using WHO criteria.&#xD;
&#xD;
          2. Age ≥ 18 years&#xD;
&#xD;
          3. Maximal debulking surgery (at the discretion of the investigator). Biopsy alone is not&#xD;
             exclusionary.&#xD;
&#xD;
          4. KPS ≥ 70&#xD;
&#xD;
          5. Life expectancy of at least 3 months.&#xD;
&#xD;
          6. Sexually active participants must agree to the strict use of barrier contraception.&#xD;
&#xD;
          7. Patients must be able to understand the investigational nature of the study and&#xD;
             provide informed consent.&#xD;
&#xD;
          8. Adequate hematologic function:&#xD;
&#xD;
               1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L&#xD;
&#xD;
               2. Platelet count ) ≥ 100 x 109/L&#xD;
&#xD;
               3. Hemoglobin ≥ 10 g /dL&#xD;
&#xD;
          9. Adequate liver function&#xD;
&#xD;
               1. Total bilirubin ≤ 1.5 x ULN&#xD;
&#xD;
               2. AST and ALT ≤ 2.5 x ULN&#xD;
&#xD;
         10. Adequate renal function&#xD;
&#xD;
             a. Creatinine ≤ 1.25 x ULN&#xD;
&#xD;
         11. International normalized ratio (INR) or PT and activated partial thromboplastin time&#xD;
             (aPTT): 1.5 x ULN (except for subjects receiving anticoagulation therapy). Use of&#xD;
             anticoagulants is permitted as long as the INR or aPTT are within therapeutic limits&#xD;
             (according to the medical standard of the institution).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active participation in another clinical treatment trial. Concomitant protocols for&#xD;
             data or tissue collection without intervention are permitted.&#xD;
&#xD;
          2. Any prior treatment for GBM aside from surgery, including carmustine wafers.&#xD;
&#xD;
          3. Women who are pregnant or nursing.&#xD;
&#xD;
          4. Severe acute or chronic medical or psychiatric condition or laboratory abnormality&#xD;
             that could increase the risk associated with trial participation, NovoTTF-200A device&#xD;
             use or interfere with interpretation of trial results and, in the judgment of the&#xD;
             investigator, would make the patient inappropriate for entry into the trial. This&#xD;
             includes but not limited to:&#xD;
&#xD;
               1. Patients with inadequately healed surgical incisions or other dermatologic scalp&#xD;
                  toxicity at baseline (grade 2 or higher, as defined in Section VIII) upon which&#xD;
                  transducer leads may require placement.&#xD;
&#xD;
               2. Known HIV or other immunosuppressive disease, chronic hepatitis B or hepatitis C&#xD;
&#xD;
               3. Dementia or significantly altered mental status that would prohibit the&#xD;
                  understanding or rendering of informed consent and compliance with the&#xD;
                  requirements of the protocol.&#xD;
&#xD;
          5. Implanted pacemaker, programmable shunt, cardiac defibrillator, deep brain stimulator,&#xD;
             other implanted electronic devices in the brain or documented clinically significant&#xD;
             arrhythmias.&#xD;
&#xD;
          6. Infratentorial glioblastoma.&#xD;
&#xD;
          7. Past hypersensitivity reaction to temozolomide or DTIC.&#xD;
&#xD;
          8. Psychiatric illness that compromises the informed consent process, at the discretion&#xD;
             of the investigator.&#xD;
&#xD;
          9. Inability or unwillingness to return for required visits.&#xD;
&#xD;
         10. Previous cytotoxic therapy within the last 5 years.&#xD;
&#xD;
         11. Inability to begin temozolomide concomitant to radiation therapy, for reasons 4 or 7&#xD;
             above.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samuel Goldlust, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hackensack Meridian Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>John Theurer Cancer Center at Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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    <PMID>24794308</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Temozolomide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03232424
org study id: Pro2017-0087
nct id: NCT03232424
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This study is a prospective single arm trial designed to study the safety, feasibility and
      preliminary efficacy of a medical device, NovoTTF-200A used concomitantly with standard
      adjuvant treatment for newly diagnosed glioblastoma.
A prospective, single arm, non-randomized, open label pilot trial will enroll ten patients
      with histologically-confirmed newly diagnosed GBM who meet all eligibility criteria. Patients
      will be recruited to the study by the principal investigator (PI) or one of the
      co-investigators (CI) at one institution, Hackensack University Medical Center. Accrual is
      expected to continue for 18 months.

      The protocol has a planned enrollment of 10 patients. Should patients discontinue treatment
      on protocol for reasons unrelated to toxicity (e.g. lost to follow-up, withdrawal of
      consent), additional patient (s) may be enrolled to complete enrollment.

      Following maximal debulking surgery, patients will undergo a gadolinium enhanced brain MRI
      within 72 hours and a screening visit 2 to 4 weeks following surgery. Extent of resection
      will be recorded as biopsy, partial resection or gross-total resection based upon residual
      enhancing tumor on post-operative MRI.The day prior to XRT start, patients will have a clinic
      visit for training and application of the NovoTTF-200A device. During this visit, the patient
      will be educated regarding general use and maintenance of the device, with a particular focus
      upon strategies to prevent, identify and manage dermatologic adverse events (dAE).
      Temozolomide will be dosed nightly during XRT as per standard of care, and NovoTTF-200A will
      be worn continuously, removed during XRT and replaced as soon as possible thereafter.

      During XRT and for 12 weeks to follow, the patient will have study visits at regular
      intervals (TAB A) for a physical examination and to assess toxicity and device compliance.
      Visits outlined in TAB A are in addition to weekly visits during radiotherapy with the
      treating radiation oncologist. MRI will be obtained at 4 weeks (+/-7 days) and 12 weeks (+/-7
      days) following completion of XRT, and maintenance temozolomide will recommence in 5/28 day
      cycles as per standard of care. Objective response will be assessed as defined by the
      Response Assessment in Neuro-Oncology (RANO) criteria (TAB C) by the treating physician and
      confirmed by a second investigator.

      In the case of suspected pseudoprogression, continued treatment and subsequent evaluations
      will help clarify whether it is true progression. Patients may continue treatment at the
      discretion of the investigator. If subsequent evaluations suggest that the tumor has in fact
      progressed, the date of progression will reflex to the date when the issue was first raised.
      However, if subsequent evaluations demonstrate improvement without change in therapy, the
      initial tumor increase may be considered pseudoprogression and response may be recorded as
      not evaluable for that time point. In the case of clinical progression, an unscheduled MRI
      will be obtained within 1 week of the investigator becoming aware of the clinical
      progression. No additional MRIs will be required after progression.

      Temozolomide and NovoTTF-200A will continue until the final study visit, or until disease
      progression or unacceptable toxicity. Thereafter, temozolomide, MRI and response assessments
      will continue as per standard of care. Following the final study visit, the patient will be
      followed at a minimum of every two months for survival, either by phone or in person. If the
      patient is free of unacceptable toxicity attributable to NovoTTF-200A, they will be offered
      the opportunity to continue the device at no financial cost, but without obligation to do so.

      Unacceptable toxicity includes the occurrence of device related serious adverse events or
      clinical and functional deterioration considered by the investigator to be prohibitive of
      continuing treatment. Treatment with the NovoTTF-200A device does not need to be terminated
      in the case of temozolomide toxicity.

      The primary endpoint will be safety and tolerability of combined modality treatment with
      radiotherapy, temozolomide and NovoTTF-200A, based upon the incidence and severity of adverse
      events. Secondary endpoints will be overall survival, progression free survival and quality
      of life.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective, single arm, non-randomized, open label pilot
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: 24 months
description: Safety and tolerability of combined modality treatment with radiotherapy, temozolomide and NovoTTF-200A based upon the incidence and severity of adverse events.
measure: Overall survival time
time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
description: Assessed from NovoTTF-200A start date to date of death of any cause. Patients will be censored at the time that they are last known to be alive (if withdrawn or lost to follow-up).
measure: Progression free survival at 6 months
time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
description: Assessed from NovoTTF-200A start date to the date of the first observation of clinical or radiographic disease progression or death due to any cause. Patients will be censored at the time they are last known to be alive and progression free (if withdrawn or lost to follow-up).
measure: Quality of life assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30)
time frame: 24 months
description: Change from baseline at each measure will be calculated for each subscale domain and symptom scale in the questionnaire. The QLQ-C30 incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. The response scale to each question ranges from 1 (Not at All) to 4 (Very Much). For each subscale domain and symptom scale, the change from baseline will summarized as mean (SD) or median (interquartile range), as appropriate.
measure: Quality of life assessed using a European Organization for Research and Treatment of Cancer (EORTC) Brain Cancer questionnaire (BN20)
time frame: 24 months
description: Change from baseline at each measure will be calculated for each subscale domain and symptom scale in the questionnaire. The questionnaire includes 20 items assessing future uncertainty, visual disorder, motor dysfunction, communication deficit and other disease symptoms (e.g. headaches and seizures) and treatment toxicities (e.g. hair loss). The response scale to each question ranges from 1 (Not at All) to 4 (Very Much). For each subscale domain and symptom scale, the change from baseline will summarized as mean (SD) or median (interquartile range), as appropriate.
arm group label: NovoTTF-200A + Temozolomide Chemoradiation
arm group type: Experimental
description: NovoTTF-200A, concomitant with radiotherapy and temozolomide, as front-line therapy for glioblastoma
intervention type: Device
intervention name: NovoTTF-200A
description: Begins the day prior to radiotherapy start and continues until the end of temozolomide maintenance cycle #2 or until evidence of disease progression or unacceptable toxicity.
Arrays are removed immediately prior to radiotherapy and replaced immediately thereafter.
arm group label: NovoTTF-200A + Temozolomide Chemoradiation
other name: Optune
intervention type: Drug
intervention name: Temozolomide
description: Concomitant phase:
75 mg/m2 per day for 42 days concomitant with radiotherapy.
Begins 1 day prior to XRT start.
Maintenance phase:
Begins 4 weeks after concomitant phase completion (+/- 1 week).
Each cycle is 28 days (5 days of drug treatment followed by 23 days without).
Cycle 1: 150 mg/m2 once daily for the first 5 days of each treatment cycle.
Subsequent cycles: daily dose increased to 200 mg/m2, if the CTC non-hematologic toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/L, and the platelet count is ≥ 100 x 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.
arm group label: NovoTTF-200A + Temozolomide Chemoradiation
intervention type: Radiation
intervention name: 3D conformal or intensity modulated radiation therapy (IMRT)
description: Radiotherapy will commence 4 weeks after the definitive surgical procedure (+/- 1 week), to a total dose of 54.0 - 60.0 Gy, delivered in 1.8 - 2.0 Gy fractions over 6 - 7 weeks. XRT target volumes will be determined utilizing all available imaging studies that best delineate extent of disease. Fusion image registration for treatment planning will be utilized as possible. Either 3D conformal or intensity modulated radiation therapy (IMRT) will be utilized.
arm group label: NovoTTF-200A + Temozolomide Chemoradiation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Samuel Goldlust, MD
role: Principal Investigator
affiliation: Hackensack Meridian Health
facility: 
country: United States
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PMID: 24794308
responsible party type: Sponsor
mesh term: Glioblastoma
mesh term: Temozolomide
sharing ipd: No