<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/NCT03258021</url>
  </required_header>
  <id_info>
    <org_study_id>05.07.2017</org_study_id>
    <nct_id>NCT03258021</nct_id>
  </id_info>
  <brief_title>TTFields In GErmany in Routine Clinical Care</brief_title>
  <acronym>TIGER</acronym>
  <official_title>The Use of TTFields for Newly Diagnosed GBM Patients in Germany in Routine Clinical Care - TIGER Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NovoCure Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NovoCure Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this post-authorisation medical device study is to obtain real life data on&#xD;
      the use of tumor-treating fields (TTFields) in patients with newly diagnosed GBM in routine&#xD;
      clinical care in Germany. Patients with newly diagnosed GBM and clinical indication for&#xD;
      TTFields treatment will be enrolled in the study after signing Informed consent to use their&#xD;
      data and process it centrally for research purposes. The clinical indication for TTFields is&#xD;
      one of the inclusion criteria and is defined prior to inclusion by the treating physician.&#xD;
      The patient's decision regarding TTFields treatment is part of the observation and will be&#xD;
      assessed within the baseline visit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Glioblastoma (GBM) is the most common malignant primary tumor of the brain. The current&#xD;
      standard of care for patients with newly diagnosed GBM consists of maximal surgical&#xD;
      resection, approx. 60 Gy of radiotherapy together with chemotherapy using temozolomide (TMZ),&#xD;
      followed by maintenance TMZ for 6 months. This treatment scheme was shown to extend median&#xD;
      survival from 12.1 to 14.6 months compared to surgery and radiotherapy alone. This survival&#xD;
      was essentially unchanged since 2005 despite numerous clinical Phase 3 trials conducted.&#xD;
&#xD;
      Although immense efforts were made over the years with different treatment strategies, the&#xD;
      survival of patients with newly diagnosed GBM remained very poor until recently.&#xD;
      Tumor-treating fields (TTFields) are low-intensity, intermediate frequency, alternating&#xD;
      electric fields delivered continuously through adhesive patches, called transducer arrays, to&#xD;
      the area of the brain where the GBM tumor is located and help slow down or stop glioblastoma&#xD;
      cancer cells from dividing. These transducer arrays are applied to the scalp and are&#xD;
      connected to the wearable and portable device.&#xD;
&#xD;
      TTFields are the first treatment since 2005 to demonstrate significantly extended median&#xD;
      overall survival and significantly improved long-term survival (one to five year survival&#xD;
      rates) compared to the current standard of care. In addition, TTFields significantly extended&#xD;
      progression-free survival.&#xD;
&#xD;
      In the Phase 3 trial in newly diagnosed GBM (trial EF-14) the results demonstrated that the&#xD;
      addition of TTFields to maintenance TMZ significantly extends both, median and long term&#xD;
      survival, as well as progression free survival of patients with newly diagnosed GBM. The&#xD;
      magnitude of survival benefit seen is even better to that seen for addition of TMZ to&#xD;
      radiation, which established TMZ as the standard of care for 1st line GBM treatment in 2005.&#xD;
      Quality of life (QoL) was maintained with the use of TTFields + TMZ in patients for whom 12&#xD;
      months of QoL data were available. The addition of TTFields to TMZ therapy in patients with&#xD;
      newly diagnosed glioblastoma was not associated with any significant increase in systemic&#xD;
      toxic effects compared with TMZ therapy alone. The most commonly reported side effect from&#xD;
      the delivery of TTFields was a mild-to-moderate skin irritation beneath the transducer&#xD;
      arrays.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 31, 2017</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time to death of any cause (overall survival (OS)) from diagnosis</measure>
    <time_frame>through study completion, an average of 18 months (mean FU time)</time_frame>
    <description>Time to death of any cause (overall survival (OS)) from diagnosis is measured using the patient data from date of enrollment until the date of death from any cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of TTFields treatment-related serious adverse events (SAEs) standardized to one year of FU time</measure>
    <time_frame>through study completion, an average of 18 months (mean follow-up time)</time_frame>
    <description>Number of TTFields treatment-related SAEs standardized to one year of follow-up (FU) is measured using the collection of SAEs during the follow-up period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of SAEs after start of TTFields treatment</measure>
    <time_frame>through study completion, an average of 18 months (mean follow-up time)</time_frame>
    <description>Number of SAEs after start of TTFields treatment is measured using the collection of SAEs at the follow-up period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of usage (compliance) of TTFields treatment over time</measure>
    <time_frame>through study completion, an average of 18 months (mean follow-up time)</time_frame>
    <description>Time of usage (compliance) of TTFields treatment over time is measured using the treatment compliance report at the Follow-up period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to first progression of GBM (progression-free survival (PFS)), defined within radiological and/or clinical/neurological assessment during routine clinical care in patients who started TTFields treatment at baseline</measure>
    <time_frame>through study completion, an average of 18 months (mean follow-up time)</time_frame>
    <description>Time to first progression of GBM (progression-free survival (PFS)), defined within radiological and/or clinical/neurological assessment during routine clinical care in patients who started TTFields treatment at baseline from date of enrollment until the date of first progression of GBM</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in quality of life at month 2 and month 4 after start of TTFields treatment compared to baseline in patients who started TTFields treatment at baseline</measure>
    <time_frame>month 2 and month 4 after start of TTFields treatment compared to baseline in patients who started TTFields treatment at baseline</time_frame>
    <description>Changes in quality of life assessed via questionnaires EORTC Quality of life questionnaires (QLQ) QLQ-C30 and BN20 after start of TTFields treatment compared to baseline in patients who started TTFields treatment at baseline is measured using the QoL questionnaires at months two and four after start of TTFields treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patients' reason(s) for refusing TTFields at baseline</measure>
    <time_frame>baseline</time_frame>
    <description>Patients' reason(s) for refusing TTFields is measured using a study specific questionnaire at baseline</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">710</enrollment>
  <condition>Glioblastoma</condition>
  <arm_group>
    <arm_group_label>GBM with indication for TTFields</arm_group_label>
    <description>newly diagnosed GBM with clinical indication for TTFields</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TTFields</intervention_name>
    <description>Tumor treating fields (TTFields) help slow down or stop glioblastoma cancer cells from dividing by disrupting dividing mechanism of cancer cells leading to apoptosis. TTFields are low-intensity, intermediate frequency, alternating electric fields delivered continuously through adhesive patches, called transducer arrays, to the area of the brain where the GBM tumor is located. These transducer arrays are applied to the scalp and are connected to the wearable and portable device. TTFields are approved for the treatment of newly diagnosed and recurrent GBM.</description>
    <arm_group_label>GBM with indication for TTFields</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with newly diagnosed GBM with clinical indication for TTFields treatment, as&#xD;
        indicated by the treating physician, will be included in the study, provided all inclusion&#xD;
        and no exclusion criteria are met and written consent is given to use and process their&#xD;
        routine clinical data according to data privacy standards.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed histologically confirmed GBM (WHO-Grade IV)&#xD;
&#xD;
          -  Patient within first 3 cycles of first-line tumor-specific maintenance chemotherapy&#xD;
&#xD;
          -  ≥ 18 years of age&#xD;
&#xD;
          -  Clinical indication for TTFields treatment&#xD;
&#xD;
          -  Given informed consent for use and processing of data&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Present or planned pregnancy&#xD;
&#xD;
          -  Significant additional neurological disease (e.g. significantly increased&#xD;
             intracerebral pressure (ICP) with a significant midline shift of the brain)&#xD;
&#xD;
          -  Active implanted medical device (e.g. deep brain stimulator)&#xD;
&#xD;
          -  Documented allergy to conductive hydrogel&#xD;
&#xD;
          -  Skull defect (e.g. missing bone with no replacement, bullet fragments in the skull)&#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>Oliver Bähr, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical center Aschaffenburg-Alzenau, Aschaffenburg, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical center Aschaffenburg-Alzenau</name>
      <address>
        <city>Aschaffenburg</city>
        <state>Bavaria</state>
        <zip>63739</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Dolecek TA, Propp JM, Stroup NE, Kruchko C. CBTRUS statistical report: primary brain and central nervous system tumors diagnosed in the United States in 2005-2009. Neuro Oncol. 2012 Nov;14 Suppl 5(Suppl 5):v1-49. doi: 10.1093/neuonc/nos218. No abstract available. Erratum In: Neuro Oncol. 2013 May;15(5):646-7.</citation>
    <PMID>23095881</PMID>
  </reference>
  <reference>
    <citation>Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.</citation>
    <PMID>15758009</PMID>
  </reference>
  <reference>
    <citation>Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.</citation>
    <PMID>26670971</PMID>
  </reference>
  <reference>
    <citation>Kesari S, Ram Z; EF-14 Trial Investigators. Tumor-treating fields plus chemotherapy versus chemotherapy alone for glioblastoma at first recurrence: a post hoc analysis of the EF-14 trial. CNS Oncol. 2017 Jul;6(3):185-193. doi: 10.2217/cns-2016-0049. Epub 2017 Apr 12.</citation>
    <PMID>28399638</PMID>
  </reference>
  <reference>
    <citation>Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbaly V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.</citation>
    <PMID>22608262</PMID>
  </reference>
  <reference>
    <citation>Mrugala MM, Engelhard HH, Dinh Tran D, Kew Y, Cavaliere R, Villano JL, Annenelie Bota D, Rudnick J, Love Sumrall A, Zhu JJ, Butowski N. Clinical practice experience with NovoTTF-100A system for glioblastoma: The Patient Registry Dataset (PRiDe). Semin Oncol. 2014 Oct;41 Suppl 6:S4-S13. doi: 10.1053/j.seminoncol.2014.09.010. Epub 2014 Sep 16. Erratum In: Semin Oncol. 2015 Jun;42(3):e33-43.</citation>
    <PMID>25213869</PMID>
  </reference>
  <reference>
    <citation>Kirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5.</citation>
    <PMID>17551011</PMID>
  </reference>
  <reference>
    <citation>Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.</citation>
    <PMID>15126372</PMID>
  </reference>
  <reference>
    <citation>Giladi M, Schneiderman RS, Voloshin T, Porat Y, Munster M, Blat R, Sherbo S, Bomzon Z, Urman N, Itzhaki A, Cahal S, Shteingauz A, Chaudhry A, Kirson ED, Weinberg U, Palti Y. Mitotic Spindle Disruption by Alternating Electric Fields Leads to Improper Chromosome Segregation and Mitotic Catastrophe in Cancer Cells. Sci Rep. 2015 Dec 11;5:18046. doi: 10.1038/srep18046.</citation>
    <PMID>26658786</PMID>
  </reference>
  <reference>
    <citation>Gera N, Yang A, Holtzman TS, Lee SX, Wong ET, Swanson KD. Tumor treating fields perturb the localization of septins and cause aberrant mitotic exit. PLoS One. 2015 May 26;10(5):e0125269. doi: 10.1371/journal.pone.0125269. eCollection 2015.</citation>
    <PMID>26010837</PMID>
  </reference>
  <reference>
    <citation>Kanner AA, Wong ET, Villano JL, Ram Z; EF-11 Investigators. Post Hoc analyses of intention-to-treat population in phase III comparison of NovoTTF-100A system versus best physician's choice chemotherapy. Semin Oncol. 2014 Oct;41 Suppl 6:S25-34. doi: 10.1053/j.seminoncol.2014.09.008. Epub 2014 Sep 16. Erratum In: Semin Oncol. 2015 Jun;42(3):e56-66.</citation>
    <PMID>25213871</PMID>
  </reference>
  <reference>
    <citation>Stupp R, Taillibert S, Kanner A, Read W, Steinberg D, Lhermitte B, Toms S, Idbaih A, Ahluwalia MS, Fink K, Di Meco F, Lieberman F, Zhu JJ, Stragliotto G, Tran D, Brem S, Hottinger A, Kirson ED, Lavy-Shahaf G, Weinberg U, Kim CY, Paek SH, Nicholas G, Bruna J, Hirte H, Weller M, Palti Y, Hegi ME, Ram Z. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2306-2316. doi: 10.1001/jama.2017.18718. Erratum In: JAMA. 2018 May 1;319(17):1824.</citation>
    <PMID>29260225</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>January 27, 2021</last_update_submitted>
  <last_update_submitted_qc>January 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glioblastoma</keyword>
  <keyword>GBM</keyword>
  <keyword>Tumor-treating fields</keyword>
  <keyword>TTFields</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03258021
org study id: 05.07.2017
nct id: NCT03258021
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this post-authorisation medical device study is to obtain real life data on
      the use of tumor-treating fields (TTFields) in patients with newly diagnosed GBM in routine
      clinical care in Germany. Patients with newly diagnosed GBM and clinical indication for
      TTFields treatment will be enrolled in the study after signing Informed consent to use their
      data and process it centrally for research purposes. The clinical indication for TTFields is
      one of the inclusion criteria and is defined prior to inclusion by the treating physician.
      The patient's decision regarding TTFields treatment is part of the observation and will be
      assessed within the baseline visit.
Glioblastoma (GBM) is the most common malignant primary tumor of the brain. The current
      standard of care for patients with newly diagnosed GBM consists of maximal surgical
      resection, approx. 60 Gy of radiotherapy together with chemotherapy using temozolomide (TMZ),
      followed by maintenance TMZ for 6 months. This treatment scheme was shown to extend median
      survival from 12.1 to 14.6 months compared to surgery and radiotherapy alone. This survival
      was essentially unchanged since 2005 despite numerous clinical Phase 3 trials conducted.

      Although immense efforts were made over the years with different treatment strategies, the
      survival of patients with newly diagnosed GBM remained very poor until recently.
      Tumor-treating fields (TTFields) are low-intensity, intermediate frequency, alternating
      electric fields delivered continuously through adhesive patches, called transducer arrays, to
      the area of the brain where the GBM tumor is located and help slow down or stop glioblastoma
      cancer cells from dividing. These transducer arrays are applied to the scalp and are
      connected to the wearable and portable device.

      TTFields are the first treatment since 2005 to demonstrate significantly extended median
      overall survival and significantly improved long-term survival (one to five year survival
      rates) compared to the current standard of care. In addition, TTFields significantly extended
      progression-free survival.

      In the Phase 3 trial in newly diagnosed GBM (trial EF-14) the results demonstrated that the
      addition of TTFields to maintenance TMZ significantly extends both, median and long term
      survival, as well as progression free survival of patients with newly diagnosed GBM. The
      magnitude of survival benefit seen is even better to that seen for addition of TMZ to
      radiation, which established TMZ as the standard of care for 1st line GBM treatment in 2005.
      Quality of life (QoL) was maintained with the use of TTFields + TMZ in patients for whom 12
      months of QoL data were available. The addition of TTFields to TMZ therapy in patients with
      newly diagnosed glioblastoma was not associated with any significant increase in systemic
      toxic effects compared with TMZ therapy alone. The most commonly reported side effect from
      the delivery of TTFields was a mild-to-moderate skin irritation beneath the transducer
      arrays.
observational model: Other
time perspective: Prospective
measure: Time to death of any cause (overall survival (OS)) from diagnosis
time frame: through study completion, an average of 18 months (mean FU time)
description: Time to death of any cause (overall survival (OS)) from diagnosis is measured using the patient data from date of enrollment until the date of death from any cause
measure: Number of TTFields treatment-related serious adverse events (SAEs) standardized to one year of FU time
time frame: through study completion, an average of 18 months (mean follow-up time)
description: Number of TTFields treatment-related SAEs standardized to one year of follow-up (FU) is measured using the collection of SAEs during the follow-up period
measure: Number of SAEs after start of TTFields treatment
time frame: through study completion, an average of 18 months (mean follow-up time)
description: Number of SAEs after start of TTFields treatment is measured using the collection of SAEs at the follow-up period
measure: Time of usage (compliance) of TTFields treatment over time
time frame: through study completion, an average of 18 months (mean follow-up time)
description: Time of usage (compliance) of TTFields treatment over time is measured using the treatment compliance report at the Follow-up period
measure: Time to first progression of GBM (progression-free survival (PFS)), defined within radiological and/or clinical/neurological assessment during routine clinical care in patients who started TTFields treatment at baseline
time frame: through study completion, an average of 18 months (mean follow-up time)
description: Time to first progression of GBM (progression-free survival (PFS)), defined within radiological and/or clinical/neurological assessment during routine clinical care in patients who started TTFields treatment at baseline from date of enrollment until the date of first progression of GBM
measure: Changes in quality of life at month 2 and month 4 after start of TTFields treatment compared to baseline in patients who started TTFields treatment at baseline
time frame: month 2 and month 4 after start of TTFields treatment compared to baseline in patients who started TTFields treatment at baseline
description: Changes in quality of life assessed via questionnaires EORTC Quality of life questionnaires (QLQ) QLQ-C30 and BN20 after start of TTFields treatment compared to baseline in patients who started TTFields treatment at baseline is measured using the QoL questionnaires at months two and four after start of TTFields treatment
measure: Patients' reason(s) for refusing TTFields at baseline
time frame: baseline
description: Patients' reason(s) for refusing TTFields is measured using a study specific questionnaire at baseline
arm group label: GBM with indication for TTFields
description: newly diagnosed GBM with clinical indication for TTFields
intervention type: Device
intervention name: TTFields
description: Tumor treating fields (TTFields) help slow down or stop glioblastoma cancer cells from dividing by disrupting dividing mechanism of cancer cells leading to apoptosis. TTFields are low-intensity, intermediate frequency, alternating electric fields delivered continuously through adhesive patches, called transducer arrays, to the area of the brain where the GBM tumor is located. These transducer arrays are applied to the scalp and are connected to the wearable and portable device. TTFields are approved for the treatment of newly diagnosed and recurrent GBM.
arm group label: GBM with indication for TTFields
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Oliver Bähr, Prof.
role: Principal Investigator
affiliation: Clinical center Aschaffenburg-Alzenau, Aschaffenburg, Germany
facility: 
country: Germany
citation: Dolecek TA, Propp JM, Stroup NE, Kruchko C. CBTRUS statistical report: primary brain and central nervous system tumors diagnosed in the United States in 2005-2009. Neuro Oncol. 2012 Nov;14 Suppl 5(Suppl 5):v1-49. doi: 10.1093/neuonc/nos218. No abstract available. Erratum In: Neuro Oncol. 2013 May;15(5):646-7.
PMID: 23095881
citation: Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.
PMID: 15758009
citation: Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.
PMID: 26670971
citation: Kesari S, Ram Z; EF-14 Trial Investigators. Tumor-treating fields plus chemotherapy versus chemotherapy alone for glioblastoma at first recurrence: a post hoc analysis of the EF-14 trial. CNS Oncol. 2017 Jul;6(3):185-193. doi: 10.2217/cns-2016-0049. Epub 2017 Apr 12.
PMID: 28399638
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responsible party type: Sponsor
mesh term: Glioblastoma
sharing ipd: No