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Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by NovoCure Ltd.
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd.
ClinicalTrials.gov Identifier:
NCT00916409
First received: June 5, 2009
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

The study is a prospective, randomly controlled pivotal trial, designed to test the efficacy and safety of a medical device, the NovoTTF-100A, as an adjuvant to the best standard of care in the treatment of newly diagnosed GBM patients. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.


Condition Intervention Phase
Glioblastoma Multiforme
Device: NovoTTF-100A device
Drug: Temozolomide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients With Newly Diagnosed GBM.

Resource links provided by NLM:


Further study details as provided by NovoCure Ltd.:

Primary Outcome Measures:
  • Progression Free Survival (PFS) time [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: June 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NovoTTF-100A device in combination with Temozolomide
patients will be treated continuously with the NovoTTF-100A device, in addition to Temozolomide. NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine.
Device: NovoTTF-100A device
patients will be treated continuously with the NovoTTF-100A device, in addition to Temozolomide. NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine.
Active Comparator: Temozolomide alone, as the best known standard of care
Patients will be treated with Temozolomide, as the best known standard of care for Glioblastoma Multiforme patients.
Drug: Temozolomide

maintenance Temozolomide will be administered according to the approved dosing scheme as follows: Maintenance Phase Cycle 1: Four weeks after completing the Temozolomide + Radiotherapy phase, Temozolomide is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.

Cycles 2-6: At the start of Cycle 2, the dose is escalated 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. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathological evidence of GBM using WHO classification criteria.
  2. > 18 years of age.
  3. Received maximal debulking surgery and radiotherapy concomitant with Temozolomide (45-70Gy):

    1. Patients may enroll in the study if received Gliadel wafers before entering the trial
    2. Any additional treatments received prior to enrollment will be considered an exclusion.
    3. Minimal dose for concomitant radiotherapy is 45 Gy
  4. Karnofsky scale ≥ 70
  5. Life expectancy at least 3 months
  6. Participants of childbearing age must use effective contraception.
  7. All patients must sign written informed consent.
  8. Treatment start date at least 4 weeks out from surgery.
  9. Treatment start date at least 4 weeks out but not more than 7 weeks from the later of last dose of concomitant Temozolomide or radiotherapy.

Exclusion Criteria:

  1. Progressive disease (according to MacDonald Criteria). If pseudoprogression is suspected, additional imaging studies must be performed to rule out true progression.
  2. Actively participating in another clinical treatment trial
  3. Pregnant
  4. Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment:

    1. Thrombocytopenia (platelet count < 100 x 103/μL)
    2. Neutropenia (absolute neutrophil count < 1.5 x 103/μL)
    3. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
    4. Significant liver function impairment - AST or ALT > 3 times the upper limit of normal
    5. Total bilirubin > upper limit of normal
    6. Significant renal impairment (serum creatinine > 1.7 mg/dL)
  5. Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
  6. Infra-tentorial tumor
  7. Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
  8. History of hypersensitivity reaction to Temozolomide or a history of hypersensitivity to DTIC.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916409

Contacts
Contact: Ghazala Kabani patientinfo@novocure.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294-3410
Contact: Thiru Pillay, RN    205-934-1842    tpillay@uabmc.edu   
Principal Investigator: Hassan Fathallah-Shaykh, MD, Phd         
United States, Arizona
Barrow Neurology Clinics Recruiting
Phoenix, Arizona, United States, 85013
Contact: Andrea Ralph    602-406-6275    andrea.ralph@dignityhealth.org   
Principal Investigator: Lynn S Ashby, MD         
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010-3000
Contact: Alex Ching    626-471-9393    aching@coh.org   
Principal Investigator: Jana Portnow, MD         
University of California San Diego Moores Cancer Center (UCSD) Recruiting
La Jolla, California, United States, 92093
Contact: Pam Vranis Vranis    858-822-1847    pvranis@ucsd.edu   
Principal Investigator: Santosh Kesari, M.D., PhD.         
University of Southern California (USC) Recruiting
Los Angeles, California, United States, 90033
Contact: Lydia Wilson, NP    323-865-3945    lydia.wilson@med.usc.edu   
Principal Investigator: Thomas C. Chen, M.D., PhD.         
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Monica Robischon, RN    727-848-0661    Monica.robischon@ucdenver.edu   
Principal Investigator: Douglas E Ney, MD         
United States, Florida
UF Health Cancer Center at Orlando Health Recruiting
Orlando, Florida, United States, 32806
Contact: Jennifer R Pelley, BSN, RN, CCRP    321 841 4348    Jennifer.Pelley@orlandohealth.com   
Principal Investigator: Nicholas G. Avgeropoulos, M.D.         
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Allie Drew    813-745-3229    allie.drew@moffitt.org   
Principal Investigator: Nam D Tran, M.D.,Ph.D.         
United States, Georgia
Emory University, Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Katarzyna "Kasia" Kopcewicz, CCRC    404-778-2981    kkopcew@emory.edu   
Principal Investigator: Willam Read, MD         
United States, Illinois
University of Illinois at Chicago (UIC) Recruiting
Chicago, Illinois, United States, 60612
Contact: Joanna Hill Hill    312-996-9272    joanhill@uic.edu   
Principal Investigator: Herbert H. Engelhard, M.D., PhD.         
United States, Kentucky
University of Kentucky, Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: John Villano, MD, PhD    859-257-3379    jlvillano@uky.edu   
Contact: Tonya Gardner, CRC    (859) 323-0532    tonya.gardner@uky.edu   
Principal Investigator: John Villano, MD, PhD         
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40202
Contact: Leanne Coleman    502-629-4594    leanne.coleman@nortonhealthcare.org   
Principal Investigator: Renato V. LaRocca, MD         
United States, Maine
Maine Medical Center Recruiting
Scarborough, Maine, United States, 04074
Contact: Debbie Cushing, R.N.    207-885-4438    cushid@mmc.org   
Principal Investigator: Rajiv Desai, M.D.         
United States, Maryland
The Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Sue Zhen    410-502-4081    Szhen1@jhmi.edu   
Principal Investigator: Alessandro Olivi, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Janlyn Murphy    617-667-1665    jmurphy7@bidmc.harvard.edu   
Principal Investigator: Eric T. Wong, M.D.         
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Amy Quinkert, PhD    617-636-8589    aquinkert@tuftsmedicalcenter.org   
Principal Investigator: Steven Hwang, MD         
Lahey Clinic Medical Center Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Christine Gould    781-744-3956    Christine.A.Gould@lahey.org   
Principal Investigator: Carlos A. David, M.D.         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Ken Winters, R.N.    313-916-1049    kwinter1@hfhs.org   
Principal Investigator: Tobias Walbert, MD PhD MPH         
United States, Missouri
Washington University School of Medicine, Division of Oncology Recruiting
St. Louis, Missouri, United States, 63110
Contact: Abigail Gwinn    314-747-4678    AGwinn@dom.wustl.edu   
Principal Investigator: David D. Tran, MD, PhD         
United States, New Jersey
New Jersey Neuroscience Center - JFK Medical Center Recruiting
Edison, New Jersey, United States, 08818
Contact: Charles Porbeni    732-321-7000 ext 68897    cporbeni@jfkhealth.org   
Principal Investigator: Joseph C. Landolfi, D.O.         
John Theurer Cancer Center at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Lori Cappello, RN,BSN    551-996-5098    LCappello@HackensackUMC.org   
Principal Investigator: Samuel Goldlust, MD         
United States, New York
Mount Sinai Medical Center, Department of Neurosurgery Recruiting
New York, New York, United States, 10029
Contact: Jean Hum, M.S.    212-824-7312    Jean.Hum@mssm.edu   
Principal Investigator: Isabelle M. Germano, MD, FACS         
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Melissa D Ricketts    212-746-7373    mdr2001@med.cornell.edu   
Principal Investigator: Susan Pannullo, M.D.         
United States, North Carolina
University of North Carolina Active, not recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Kathy Smolenski, RN BSN OCN    216-445-1067    smolenk2@ccf.org   
Principal Investigator: Gene Barnett, M.D.         
The Ohio State University Arthur G. James Cancer Hospital and Solove Research Institute Recruiting
Columbus, Ohio, United States, 43210
Contact: Danette Birkhimer, MS, RN, OCN, CNS    614-293-2897    danette.birkhimer@osumc.edu   
Contact: Jill Brown    614-293-5554    Jill.brown@osumc.edu   
Principal Investigator: Herbert Newton, MD         
United States, Pennsylvania
Geisinger Health System Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Angela Whitmire, RN    570-214-9603    awhitmire@geisinger.edu   
Principal Investigator: Steven A. Toms, M.D.         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Bernard Michel, BS, MS    215-615-4597    Bernard.Michel@uphs.upenn.edu   
Principal Investigator: Steven Brem, M.D.         
Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Marie T Kerr, CCRP    215-829-6720    kerm@uphs.upenn.edu   
Principal Investigator: John Lee, M.D.         
University of Pittsburgh Medical Center (UPMC) Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Melinda Vargas-Jaffe    412-235-1320    vargasjaffema@upmc.edu   
Principal Investigator: Frank S. Lieberman, M.D.         
United States, Texas
Baylor Recruiting
Dallas, Texas, United States, 75246
Contact: Amy Solis    214-820-8685    Amy.Solis@BaylorHealth.edu   
Contact: Sara Gonzales    214-820-6168    sara.gonzales@BaylorHealth.edu   
Principal Investigator: Karen L. Fink, M.D., PhD.         
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75235-8808
Contact: Irma Smith, MS, CCRP    214-645-7212    irma.charles@utsouthwestern.edu   
Principal Investigator: Kevin Choe, M.D., Ph.D.         
Methodist Neurological Institute Recruiting
Houston, Texas, United States, 77030
Contact: Kimbra Harris, CCRP    713-441-3834    KSHarris@houstonmethodist.org   
Principal Investigator: Pamela New, M.D.         
The University of Texas Health Science Center at Houston (UTHSC) Recruiting
Houston, Texas, United States, 77030
Contact: GuangRong Greg Lu    713-704-2359    GuangRong.Lu@uth.tmc.edu   
Principal Investigator: Jay-Jiguang Zhu, M.D., Ph.D.         
Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Joan W Wan    713-534-1300    qwan2009@gmail.com   
Principal Investigator: Yvonne Kew, M.D., Ph.D         
Scott and White Healthcare Recruiting
Temple, Texas, United States, 76508
Contact: Eromata Ebwe    254-724-6885    ekbwe@sw.org   
Principal Investigator: Ekokobe Fonkem, D.O.         
Memorial Hermann The Woodlands Recruiting
The Woodlands, Texas, United States, 77380
Contact: GuangRong Greg Lu    713-704-2359    GuangRong.Lu@uth.tmc.edu   
Principal Investigator: Jay-Jiguang Zhu, MD, PHD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Kim Chapman    434-243-9360    KC9ZY@hscmail.mcc.virginia.edu   
Principal Investigator: David Schiff, MD         
United States, Washington
Swedish Neuroscience Institute Recruiting
Seattle, Washington, United States, 98122
Contact: Becky Wood    206-320-7115    becky.wood@swedish.org   
Principal Investigator: John Henson, MD         
University of Washington/Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98195
Contact: Ashley Waldie    206-685-5597    awaldie@seattlecca.org   
Principal Investigator: Maciej M Mrugala         
Austria
University Hospital Graz Recruiting
Graz, Austria
Contact: Franz Payer, Prof.    +43 (0) 316 385-80388    franz.payer@meduni-graz.at   
Principal Investigator: Franz Payer, M.D.         
Medical University of Vienna Recruiting
Vienna, Austria
Contact: Christine Marosi, MD    +43 1 40400 4421    christine.marosi@meduniwien.ac.at   
Principal Investigator: Christine Marosi, MD         
SMZ-Süd/Kaiser-Franz-Josef-Spital Recruiting
Vienna, Austria
Contact: Wolfgang Grisold, MD    +43 1 60191 2008    wolfgang.grisold@wienkav.at   
Principal Investigator: Wolfgang Grisold, MD         
Canada, Alberta
Tom Baker Cancer Center Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Debra Rich    403-521-3031    Debra.Rich@AlbertaHealthServices.ca   
Principal Investigator: Jacob Easaw, MD, PhD, FRCP(C)         
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Kathi Klapp    204-787-2159    Kathi.Klapp@cancercare.mb.ca   
Principal Investigator: Marshall Pitz         
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton,, Ontario, Canada, L8V5C2
Contact: Hal Hirte    905-387-9495      
Principal Investigator: Holger (Hal) Hirte         
The Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Heather Sharpe    (613) 737-7700 ext 73281    hsharpe@toh.on.ca   
Principal Investigator: Garth Nicholas, MD, FRCPC         
Canada, Quebec
McGill - Gerald Bronfman Centre for Clinical Research in Oncology - Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Beatrice Fournier, PhD, CCRP    514-340-8222 ext 6771    bfournier@jgh.mcgill.ca   
Principal Investigator: Thierry Muanza, M.D.         
Montreal Neurological Institute Recruiting
Montreal, Quebec, Canada, H3A 2B4
Contact: Lisa Nezvitsky, M.Sc.    (514) 398-2801      
Principal Investigator: Scott Owen         
Notre-Dame Hospital (CHUM) Recruiting
Montreal, Quebec, Canada, H2L 4 M1
Contact: Diane Trudel    514-890-8000 ext 26906    diane.dt.trudel.chum@ssss.gouv.qc.ca   
Principal Investigator: David Roberge         
(CHUS) Centre Hospitalier Universitaire de Sherbrooke, Service de Neurochirurgie Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Anick Champoux    819-346-1110 ext 12811    achampoux.chus@ssss.gouv.qc.ca   
Principal Investigator: David Mathieu         
Czech Republic
Na Homolce Hospital Recruiting
Prague, Czech Republic
Contact: Jan Sroubek, M.D.    +420 (25727) 3091    Jan.Sroubek@homolka.cz   
Principal Investigator: Jan Sroubek, M.D.         
France
CHU Amiens Sud-Salouel Recruiting
Amiens, France
Contact: Bruno Chauffert, MD    +33 3 22 45 54 99    chauffert.bruno@chu-amiens.fr   
Principal Investigator: Bruno Chauffert, MD         
CHU Angers Recruiting
Angers, France
Contact: Marie-Anne Poiron    +33 02 4135 48 22    MAPoiron@chu-angers.fr   
Principal Investigator: Philippe Menei, MD, PhD         
Hôpital Saint André Centre Hospitalier Universitaire (CHU) des Hôpitaux de Bordeaux Recruiting
Bordeaux, France
Contact: Emilie Wallet, SC    +33 05 57 82 13 04    emilie.wallet@chu-bordeaux.fr   
Principal Investigator: Isabelle Catry-Thomas, MD         
Hospital of Neurology Lyon - University Claude Bernard Recruiting
Lyon, France
Contact: Linda Chami    +33 04 72 35 58 42    linda.chami@chu.lyon.fr   
Principal Investigator: Jerome Honnorat, M.D.         
Group Hospitals Pitie-Salpetriere Recruiting
Paris, France
Contact: Louise Anemet    01 42 16 04 04    louise.anemet@psl.aphp.fr   
Principal Investigator: Sophie Taillibert, M.D.         
Centre Hospitalo-Universitaire de Toulouse Purpan Recruiting
Toulouse, France
Contact: Dr. Alexandra Benouaich-Amiel, M.D.    +33 (0)5 61 77 22 71    benouaich-amiel.a@chu-toulouse.fr   
Principal Investigator: Alexandra Benouaich-Amiel, MD         
Germany
University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany
Contact: Manfred Westphal, M.D.    +49 (40) 7410-5345 3      
Principal Investigator: Manfred Westphal, M.D.         
Medical University Heidelberg Recruiting
Heidelberg, Germany
Contact: Barbara Stöhr    +49 6221 56 37243    barbara.stoehr@med.uni-heidelberg.de   
Principal Investigator: Wolfgang Wick, MD         
University Hospital of Schleswig-Holstein Recruiting
Kiel, Germany
Contact: Maximillian Mehdorn, M.D, PhD.    0049 431 597 4800    mehdorn@nch.uni-kiel.de   
Principal Investigator: Maximilian Mehdorn, M.D.         
Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Carmit Ben Harosh    972 52 426 2245    carmitbh@tasmc.health.gov.il   
Principal Investigator: Andrew Kanner, M.D.         
Italy
Az. Ospedaliero-Universitaria - Ospedali Riuniti Recruiting
Ancona, Italy
Contact: Massimo Scerrati, MD    +39 0715964578    m.scerrati@univpm.it   
Principal Investigator: Massimo Scerrati, MD         
Ospedale Lecco Recruiting
Lecco, Italy
Contact: Andrea Salmaggi    0039 0341 489111    a.salmaggi@ospedale.lecco.it   
Principal Investigator: Andrea Salmaggi, MD         
Foundation Hospital Greater Policlinico Recruiting
Milan, Italy
Contact: Manuela Caroli, M.D.    0039 02 55035528    man.caroli@tin.it   
Principal Investigator: Manuela Caroli, MD         
C. Besta Neurological Institute Recruiting
Milan, Italy
Contact: Paola Gaviani, M.D.    0039 02 2394 2440    paola.gaviani@istituto-besta.it   
Contact: Antonio Silvani, M.D.    +39 (022394) 23051    Antonio.Silvani@istituto-besta.it   
Principal Investigator: Antonio Silvani, M.D.         
Istituti Fisioterapici Ospitalieri - Istituto Nazionale dei Tumori Regina Elena Recruiting
Rome, Italy
Contact: Carmine Carapella, M.D.    +39 06 52665595    carapella@ifo.it   
Principal Investigator: Carmine Carapella, M.D.         
Korea, Republic of
Asan Medical Center Recruiting
Asan, Korea, Republic of
Contact: Ji-Young Suh    +82-2-3010-7364    jysuh@amc.seoul.kr   
Principal Investigator: Se Hyuk Kim, Prof.         
Yeungnam University Hospital Recruiting
Daegu, Korea, Republic of
Contact: Bo-Nam Seo    +82-53-624-8354      
Principal Investigator: Oh Lyong Kim, Prof.         
Chungnam National University Hospital (CNUH) Recruiting
Daejeon, Korea, Republic of
Contact: Joo-Young Lee    +82-42-280-7399    ljy99@cnuh.co.kr   
Principal Investigator: Hwan Jung Yun, Prof.         
Seoul National University Hospital (SNUH) Recruiting
Seoul, Korea, Republic of
Contact: Mi-Yeon Yoo    +82-2-2072-3993      
Principal Investigator: Sun Ha Peak, Prof.         
Yonsei University Severance Hospital (YUHS) Recruiting
Seoul, Korea, Republic of
Contact: Hyunsim Park    +82 2 2227 7867      
Contact: Se Hoon Kim         
Principal Investigator: Jong-Hee Chang, Prof.         
The Catholic University of Korea, Seoul St. Mary's Hospital (CMC Seoul) Recruiting
Seoul, Korea, Republic of
Contact: Sun-Mi Hyun    +82 2 2258 3054      
Contact: David Jae         
Principal Investigator: Yong Kil Hong, Prof.         
Seoul National University Bundang Hospital (SNUBH) Recruiting
Seoul, Korea, Republic of
Contact: Eun-jin Choi    +82-31-787-6001    r0415@snubh.org   
Principal Investigator: Chae Yong Kim, Prof.         
Samsung Medical Center (SMC) Recruiting
Seoul, Korea, Republic of
Contact: Sangok Park    +82 2 3410 0867    sangok8133.park@samsung.com   
Principal Investigator: Dohyun Nam, Prof.         
Ajou University Hospital (AUH) Recruiting
Suwon, Korea, Republic of
Contact: Joolee Park    +82-31-219-4266      
Principal Investigator: Se Hyuk Kim, Prof.         
Spain
Hospital Universitari Germans Trias i Pujol Recruiting
Badalona, Spain
Contact: Salvador Villa Freixa, MD    +34 93 497 88 05    svilla@iconcologia.net   
Principal Investigator: Salvador Villa Freixa, MD         
Hospital Universitari de Bellvitge-ICO Duran i Reynals Recruiting
Barcelona, Spain
Contact: Jordi Bruna Escuer, MD, PhD    +34 93 2607711    35078jbe@comb.cat   
Principal Investigator: Jordi Bruna Escuer, MD, PhD         
Hospital Clinic i Provincial de Barcelona Recruiting
Barcelona, Spain
Contact: Teresa Vilella, SC    +34 93 227 54 00 ext 2811    vilella@clinic.cat   
Principal Investigator: Francesc Graus Graus, MD         
Hospital del Mar Recruiting
Barcelona, Spain
Contact: María Martínez García, MD    '+34 93 248 38 62    MariaMartinezGarcia@parcdesalutmar.cat   
Principal Investigator: María Martínez García, MD         
Hospital Clinico San Carlos Recruiting
Madrid, Spain
Contact: Pedro Perez Segura, MD    +34 91330364    perezsegura09@gmail.com   
Principal Investigator: Pedro Perez Segura, MD         
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain
Contact: Maria de los Angeles Vaz, MD    +34 91 336 82 63    avaz3@yahoo.es   
Principal Investigator: Maria de los Angeles Vaz, MD         
Hospital 12 de Octubre, Servicio de Oncología Médica Recruiting
Madrid, Spain
Contact: Dr. J.M. Sepulveda, MD    +34 91 390 80 03      
Principal Investigator: Dr. J.M. Sepúlveda, MD         
Fundacion Jimenes Diaz Recruiting
Madrid, Spain
Contact: Jose de Campos, MD    +34 659 574 378    JMcampos@fjd.es   
Principal Investigator: Jose de Campos, MD         
Clínica Universidad de Navarra Recruiting
Pamplona, Spain
Contact: Jaime Gallego Perez-Larraya, MD    +34 948 25 54 00    jgallego@unav.es   
Principal Investigator: Jaime Gallego Perez-Larraya, MD         
Sweden
Karolinska Institute Recruiting
Stockholm, Sweden
Contact: Giuseppe Stragliotto, MD    +46 (0)8-517 72072    giuseppe.stragliotto@karolinska.se   
Principal Investigator: Giuseppe Stragliotto, MD         
Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV) Recruiting
Lausanne, Switzerland
Contact: Alexandra Rideau    +(41) 21 314 7629    Alexandra.Rideau@chuv.ch   
Principal Investigator: Andreas Hottinger, M.D.         
UniversitätsSpital Zürich Recruiting
Zurich, Switzerland
Contact: Verena Reichl    +41 44 255 5511    verena.reichl@usz.ch   
Principal Investigator: Michael Weller, MD         
Sponsors and Collaborators
NovoCure Ltd.
Investigators
Study Director: Roger Stupp, MD University of Lausanne Hospital - Multidisciplinary Oncology Center
Study Director: Philip H. Gutin, MD Memorial Sloan-Kettering Cancer Center
Study Director: Eric T. Wong, MD Beth Israel Deaconess Medical Center
Study Director: Herbert H. Engelhard, MD, PhD University of Illinois at Chicago
Study Director: Manfred Westphal, Prof. MD Universitätsklinikum Hamburg-Eppendorf
  More Information

Publications:
Responsible Party: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT00916409     History of Changes
Other Study ID Numbers: EF-14
Study First Received: June 5, 2009
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by NovoCure Ltd.:
Glioblastoma Multiforme
Glioblastoma
GBM
Brain tumor
Treatment
Minimal toxicity
Newly Diagnosed
TTFields
Tumor Treating Fields
NovoCure

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014