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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 November 2014 by NovoCure Ltd.
Information provided by (Responsible Party):
NovoCure Ltd. Identifier:
First received: June 5, 2009
Last updated: November 4, 2014
Last verified: November 2014

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.

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Detailed Description:


The effect of the electric fields generated by the NovoTTF-100A device (TTFields, TTF) has been tested in a large prospective, randomized trial, in recurrent GBM. The outcome of subjects treated with the NovoTTF-100A device was compared to those treated with an effective best standard of care chemotherapy (including bevacizumab). NovoTTF-100A subjects had comparable overall survival to subjects receiving the best available chemotherapy in the US today. Similar results showing comparability of NovoTTF-100A to BSC chemotherapy were seen in all secondary endpoints.

Recurrent GBM patients treated with the NovoTTF-100A device in this trial experienced fewer side effects in general, significantly fewer treatment related side effects, and significantly lower gastrointestinal, hematological and infectious adverse events compared to controls. The only device-related adverse events seen were a mild to moderate skin irritation beneath the device electrodes. Finally, quality of life measures were better in NovoTTF-100A subjects as a group when compared to subjects receiving effective best standard of care chemotherapy.

In a small scale pilot trial in newly diagnosed GBM patients, the treatment was well tolerated and suggested that NovoTTF-100A may improve time to disease progression and overall survival of newly diagnosed GBM patients. Although the number of patients in the pilot trial was small, The FDA has determined that the data gathered so far warrant testing of NovoTTF-100A treatment as a possible therapy for patients with newly diagnosed GBM.


All patients included in this trial are newly diagnosed GBM patients who underwent a biopsy or surgery (with or without Gliadel wafers), followed by radiation therapy in combination with Temozolomide chemotherapy. In addition, all patients must meet all eligibility criteria.

Eligible patients will be randomly assigned to one of two groups:

  1. Treatment with the NovoTTF-100A device in combination with Temozolomide chemotherapy.
  2. Treatment with Temozolomide alone, as the best known standard of care.

Patients will be randomized at a 2:1 ratio (2 of every three patients who participate in the trial will be treated with the NovoTTF-100A device). Baseline tests will be performed in patients enrolled in both arms, including specific genetic tests done using tumor samples obtained during their initial surgery. If assigned to the NovoTTF-100A in combination with Temozolomide group, the patients will be treated continuously with the device until second progression. They will also receive temozolomide and possibly a second line treatment that can be one of the following: re-operation, local radiotherapy (gamma-knife), a second line of chemotherapy or a combination of the above.

NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head. Electrode array placement will require shaving of the scalp before and frequently during the treatment. After an initial short visit to the clinic for training and monitoring, patients will be released to continue treatment at home where they can maintain their regular daily routine.

During the trial, regardless of which treatment group the patient was assigned to, he or she will need to return once every month to the clinic where an examination by a physician and a routine laboratory examinations will be done. These routine visits will continue for as long as the patient's disease is not progressing for the second time under the study treatment. If such occurs, patients will need to return once per month for two more months to the clinic for similar follow up examinations.

During the visits to the clinic patients will be examined physically and neurologically. Additionally, routine blood tests will be performed. A routine MRI of the head will be performed at baseline and every second month thereafter, until second progression. After this follow up plan, patients will be contacted once per month by telephone to answer basic questions about their health status.


Electric fields exert forces on electric charges similar to the way a magnet exerts forces on metallic particles within a magnetic field. These forces cause movement and rotation of electrically charged biological building blocks, much like the alignment of metallic particles seen along the lines of force radiating outwards from a magnet.

Electric fields can also cause muscles to twitch and if strong enough may heat tissues. TTFields are alternating electric fields of low intensity. This means that they change their direction repetitively many times a second. Since they change direction very rapidly (200 thousand times a second), they do not cause muscles to twitch, nor do they have any effects on other electrically activated tissues in the body (brain, nerves and heart). Since the intensities of TTFields in the body are very low, they do not cause heating.

The breakthrough finding made by NovoCure was that finely tuned alternating fields of very low intensity, now termed TTFields (Tumor Treating Fields), cause a significant slowing in the growth of cancer cells. Due to the unique geometric shape of cancer cells when they are multiplying, TTFields cause the building blocks of these cells to move and pile up in such a way that the cells physically explode. In addition, cancer cells also contain miniature building blocks which act as tiny motors in moving essential parts of the cells from place to place. TTFields cause these tiny motors to fall apart since they have a special type of electric charge.

As a result of these two effects, cancer tumor growth is slowed and can even reverse after continuous exposure to TTFields.

Other cells in the body (normal healthy tissues) are affected much less than cancer cells since they multiply at a much slower rate if at all. In addition TTFields can be directed to a certain part of the body, leaving sensitive areas out of their reach.

In conclusion, TTField hold the promise of serving as a brand new cancer treatment with very few side effects and promising affectivity in slowing or reversing this disease.


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

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 identifier: NCT00916409

Contact: Ghazala Kabani

  Hide Study Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294-3410
Contact: Thiru Pillay, RN    205-934-1842   
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   
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   
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   
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   
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   
Principal Investigator: Douglas E Ney, MD         
United States, Florida
UF Health Cancer Center at Orlando Health Recruiting
Orlando, Florida, United States, 32806
Contact: Gayatri Nair, CCRP    321-841-7477   
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   
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   
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   
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   
Contact: Tonya Gardner, CRC    (859) 323-0532   
Principal Investigator: John Villano, MD, PhD         
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40202
Contact: Leanne Coleman    502-629-4594   
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   
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   
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   
Principal Investigator: Eric T. Wong, M.D.         
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Amy Quinkert, PhD    617-636-8589   
Principal Investigator: Steven Hwang, MD         
Lahey Clinic Medical Center Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Christine Gould    781-744-3956   
Principal Investigator: Carlos A. David, M.D.         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Stephanie Marl    313-916-7231   
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   
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   
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   
Principal Investigator: Samuel Goldlust, MD         
United States, New York
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
Mount Sinai Medical Center, Department of Neurosurgery Recruiting
New York, New York, United States, 10029
Contact: Jean Hum, M.S.    212-824-7312   
Principal Investigator: Isabelle M. Germano, MD, FACS         
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Hanna D An    212-746-7373   
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   
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   
Contact: Jill Brown    614-293-5554   
Principal Investigator: Herbert Newton, MD         
United States, Pennsylvania
Geisinger Health System Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Angela Whitmire, RN    570-214-9603   
Principal Investigator: Steven A. Toms, M.D.         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Chau Nguyen    215-662-6832   
Principal Investigator: Steven Brem, M.D.         
Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Marie T Kerr, CCRP    215-829-6720   
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   
Principal Investigator: Frank S. Lieberman, M.D.         
United States, Texas
Baylor Recruiting
Dallas, Texas, United States, 75246
Contact: Amy Solis    214-820-8685   
Contact: Sara Gonzales    214-820-6168   
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   
Principal Investigator: Kevin Choe, M.D., Ph.D.         
The University of Texas Health Science Center at Houston (UTHSC) Recruiting
Houston, Texas, United States, 77030
Contact: GuangRong Greg Lu    713-704-2359   
Principal Investigator: Jay-Jiguang Zhu, M.D., Ph.D.         
Methodist Neurological Institute Recruiting
Houston, Texas, United States, 77030
Contact: Kimbra Harris, CCRP    713-441-3834   
Principal Investigator: Pamela New, M.D.         
Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Joan W Wan    713-534-1300   
Principal Investigator: Yvonne Kew, M.D., Ph.D         
Scott and White Healthcare Recruiting
Temple, Texas, United States, 76508
Contact: Melissa Ainslie    254-724-5679   
Principal Investigator: Ekokobe Fonkem, D.O.         
Memorial Hermann The Woodlands Recruiting
The Woodlands, Texas, United States, 77380
Contact: GuangRong Greg Lu    713-704-2359   
Principal Investigator: Jay-Jiguang Zhu, MD, PHD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Johanna Loomba    434-924-5859   
Principal Investigator: David Schiff, MD         
United States, Washington
University of Washington/Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98195
Contact: Ashley Waldie    206-685-5597   
Principal Investigator: Maciej M Mrugala         
Swedish Neuroscience Institute Recruiting
Seattle, Washington, United States, 98122
Contact: Becky Wood    206-320-7115   
Principal Investigator: John Henson, MD         
University Hospital Graz Recruiting
Graz, Austria
Contact: Franz Payer, Prof.    +43 (0) 316 385-80388   
Principal Investigator: Franz Payer, M.D.         
Medical University of Vienna Recruiting
Vienna, Austria
Contact: Christine Marosi, MD    +43 1 40400 4421   
Principal Investigator: Christine Marosi, MD         
SMZ-Süd/Kaiser-Franz-Josef-Spital Recruiting
Vienna, Austria
Contact: Wolfgang Grisold, MD    +43 1 60191 2008   
Principal Investigator: Wolfgang Grisold, MD         
Canada, Alberta
Tom Baker Cancer Center Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Debra Rich    403-521-3031   
Principal Investigator: Jacob Easaw, MD, PhD, FRCP(C)         
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Kathi Klapp    204-787-2159   
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   
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   
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   
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   
Principal Investigator: David Mathieu         
Czech Republic
Na Homolce Hospital Recruiting
Prague, Czech Republic
Contact: Jan Sroubek, M.D.    +420 (25727) 3091   
Principal Investigator: Jan Sroubek, M.D.         
CHU Amiens Sud-Salouel Recruiting
Amiens, France
Contact: Mathieu Boone, MD    +33 32 245 5499   
Principal Investigator: Mathieu Boone, MD         
CHU Angers Recruiting
Angers, France
Contact: Marie-Anne Poiron    +33 02 4135 48 22   
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   
Principal Investigator: Isabelle Catry-Thomas, MD         
Hospital of Neurology Pierre Wertheimer Recruiting
Lyon, France
Contact: Linda Chami    +33 04 72 35 58 42   
Principal Investigator: Jerome Honnorat, M.D.         
Group Hospitals Pitie-Salpetriere Recruiting
Paris, France
Contact: Louise Anemet    +33 142 16 04 04   
Principal Investigator: Ahmed Idbaih, 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   
Principal Investigator: Alexandra Benouaich-Amiel, MD         
University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany
Contact: Manfred Westphal, M.D.    +49 (40) 7410 53750      
Principal Investigator: Manfred Westphal, M.D.         
Medical University Heidelberg Recruiting
Heidelberg, Germany
Contact: Barbara Stöhr    +49 6221 56 37243   
Principal Investigator: Wolfgang Wick, MD         
University Hospital of Schleswig-Holstein Recruiting
Kiel, Germany
Contact: Maximillian Mehdorn, M.D, PhD.    0049 431 597 4800   
Principal Investigator: Maximilian Mehdorn, M.D.         
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Carmit Ben Harosh    972 52 426 2245   
Principal Investigator: Andrew Kanner, M.D.         
Az. Ospedaliero-Universitaria - Ospedali Riuniti Recruiting
Ancona, Italy
Contact: Massimo Scerrati, MD    +39 0715964578   
Principal Investigator: Massimo Scerrati, MD         
Ospedale Lecco Recruiting
Lecco, Italy
Contact: Andrea Salmaggi    0039 0341 489111   
Principal Investigator: Andrea Salmaggi, MD         
C. Besta Neurological Institute Recruiting
Milan, Italy
Contact: Paola Gaviani, M.D.    0039 02 2394 2440   
Contact: Antonio Silvani, M.D.    +39 (022394) 23051   
Principal Investigator: Antonio Silvani, M.D.         
Foundation Hospital Greater Policlinico Recruiting
Milan, Italy
Contact: Manuela Caroli, M.D.    0039 02 55035528   
Principal Investigator: Manuela Caroli, MD         
Istituti Fisioterapici Ospitalieri - Istituto Nazionale dei Tumori Regina Elena Recruiting
Rome, Italy
Contact: Carmine Carapella, M.D.    +39 06 52665595   
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   
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   
Principal Investigator: Hwan Jung Yun, Prof.         
Samsung Medical Center (SMC) Recruiting
Seoul, Korea, Republic of
Contact: Sangok Park    +82 2 3410 0867   
Principal Investigator: Dohyun Nam, Prof.         
Seoul National University Bundang Hospital (SNUBH) Recruiting
Seoul, Korea, Republic of
Contact: Eun-jin Choi    +82-31-787-6001   
Principal Investigator: Chae Yong Kim, 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.         
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.         
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.         
Ajou University Hospital (AUH) Recruiting
Suwon, Korea, Republic of
Contact: Joolee Park    +82-31-219-4266      
Principal Investigator: Se Hyuk Kim, Prof.         
Hospital Universitari Germans Trias i Pujol Recruiting
Badalona, Spain
Contact: Salvador Villa Freixa, MD    +34 93 497 88 05   
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   
Principal Investigator: Jordi Bruna Escuer, MD, PhD         
Hospital del Mar Recruiting
Barcelona, Spain
Contact: María Martínez García, MD    '+34 93 248 38 62   
Principal Investigator: María Martínez García, MD         
Hospital Clinic i Provincial de Barcelona Recruiting
Barcelona, Spain
Contact: Teresa Vilella, SC    +34 93 227 54 00 ext 2811   
Principal Investigator: Francesc Graus Graus, MD         
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain
Contact: Maria de los Angeles Vaz, MD    +34 91 336 82 63   
Principal Investigator: Maria de los Angeles Vaz, MD         
Fundacion Jimenes Diaz Recruiting
Madrid, Spain
Contact: Jose de Campos, MD    +34 659 574 378   
Principal Investigator: Jose de Campos, 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         
Hospital Clinico San Carlos Recruiting
Madrid, Spain
Contact: Pedro Perez Segura, MD    +34 91330364   
Principal Investigator: Pedro Perez Segura, MD         
Clínica Universidad de Navarra Recruiting
Pamplona, Spain
Contact: Jaime Gallego Perez-Larraya, MD    +34 948 25 54 00   
Principal Investigator: Jaime Gallego Perez-Larraya, MD         
Karolinska Institute Recruiting
Stockholm, Sweden
Contact: Giuseppe Stragliotto, MD    +46 (0)8-517 72072   
Principal Investigator: Giuseppe Stragliotto, MD         
Centre Hospitalier Universitaire Vaudois (CHUV) Recruiting
Lausanne, Switzerland
Contact: Alexandra Rideau    +(41) 21 314 7629   
Principal Investigator: Andreas Hottinger, M.D.         
UniversitätsSpital Zürich Recruiting
Zurich, Switzerland
Contact: Tanja Pendl    +41 44 255 5362   
Principal Investigator: Michael Weller, MD         
Sponsors and Collaborators
NovoCure Ltd.
Study Director: Roger Stupp, MD University Hospital, Zürich
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

Responsible Party: NovoCure Ltd. Identifier: NCT00916409     History of Changes
Other Study ID Numbers: EF-14
Study First Received: June 5, 2009
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 23, 2014