Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3)
NCT ID: NCT03377491
Last Updated: 2026-01-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
571 participants
INTERVENTIONAL
2018-05-10
2024-10-16
Brief Summary
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The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic adenocarcinoma.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.
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Detailed Description
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The effect of the electric fields (TTFields, TTF) has demonstrated significant activity in in vitro and in vivo pancreatic adenocarcinoma pre-clinical models both as a single modality treatment and in combination with chemotherapies. TTFields have been demonstrated to act synergistically with taxanes and have been shown to be additive when combined with other chemotherapies including gemcitabine. In addition, TTFields have shown to inhibit metastatic spread of malignant melanoma in in vivo experiment.
In a pilot study, 40 patients with locally advanced or metastatic pancreatic adenocarcinoma received gemcitabine together with TTFields (150 kHz) or gemcitabine and nab-paclitaxel together with TTFields (150 kHz) applied to the abdomen until disease progression. The combination was well tolerated and the only device-related adverse event was contact dermatitis.
In addition, a phase III trial of Optune® (200 kHz) as monotherapy compared to active chemotherapy in recurrent glioblastoma patients showed TTFields to be equivalent to active chemotherapy in extending survival, associated with minimal toxicity, good quality of life, and activity within the brain (14% response rate) (Stupp R., et al., EJC 2012). Finally, a phase III trial of Optune® combined with maintenance temozolomide compared to maintenance temozolomide alone has shown that combined therapy led to a significant improvement in both progression free survival and overall survival in patients with newly diagnosed glioblastoma without the addition of high grade toxicity and without decline in quality of life (Stupp R., et al., JAMA 2017).
DESCRIPTION OF THE TRIAL:
All patients included in this trial are patients with locally advanced pancreatic adenocarcinoma. In addition, all patients must meet all eligibility criteria.
Eligible patients will be randomly assigned to one of two groups:
1. Patients receive gemcitabine and nab-paclitaxel in combination with TTFields using the NovoTTF-200T System.
2. Patients receive gemcitabine and nab-paclitaxel without TTFields.
Patients will be randomized at a 1:1 ratio. Baseline tests will be performed in patients enrolled in both arms. If assigned to the NovoTTF-200T group, the patients will be treated continuously with the device until progression in the abdomen. On both arms, patients who have progression outside the abdomen will switch to a second line treatment according to local practice.
SCIENTIFIC BACKGROUND:
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 (150 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 electrically-charged cellular components of these cells to change their location within the dividing cell, disrupting their normal function and ultimately leading to cell death. 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 interfere with the normal orientation of these tiny motors related to other cellular components since they are electrically-charged as well. As a result of these two effects, tumor cell division is slowed, results in cellular death or reverses 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. Finally, the frequency of TTFields applied to each type of cancer is specific and may not damage normally dividing cells in healthy tissues.
In conclusion, TTFields hold the promise of serving as a brand new treatment for pancreatic adenocarcinoma with very few side effects.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NovoTTF-200T
Patients receive TTFields using the NovoTTF-200T System together with gemcitabine and nab-Paclitaxel
NovoTTF-200T
Patients receive continuous TTFields treatment using the NovoTTF-200T device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the torso. The treatment enables the patient to maintain regular daily routine.
Gemcitabine
Gemcitabine 1000 mg/m\^2 over 30 minute infusion will be administered immediately after nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle.
nab paclitaxel
nab-paclitaxel 125 mg/m\^2 administered as an intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle.
Best Standard of Care
Patients receive best standard of care with gemcitabine and nab-Paclitaxel
Gemcitabine
Gemcitabine 1000 mg/m\^2 over 30 minute infusion will be administered immediately after nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle.
nab paclitaxel
nab-paclitaxel 125 mg/m\^2 administered as an intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle.
Interventions
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NovoTTF-200T
Patients receive continuous TTFields treatment using the NovoTTF-200T device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the torso. The treatment enables the patient to maintain regular daily routine.
Gemcitabine
Gemcitabine 1000 mg/m\^2 over 30 minute infusion will be administered immediately after nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle.
nab paclitaxel
nab-paclitaxel 125 mg/m\^2 administered as an intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Life expectancy of ≥ 3 months
3. Histological/cytological diagnosis of de novo adenocarcinoma of the pancreas
4. Unresectable, locally advanced stage disease according to the following criteria:
* Head/uncinate process:
1. Solid tumor contact with SMA\>180°
2. Solid tumor contact with the CA\>180°
3. Solid tumor contact with the first jejunal SMA branch
4. Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t tumor or bland thrombus)
5. Contact with most proximal draining jejunal branch into SMV
* Body and tail
1. Solid tumor contact of \>180° with the SMA or CA
2. Solid tumor contact with the CA and aortic involvement
3. Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t tumor or bland thrombus)
* No distant metastasis, including non-regional lymph node metastasis
* No borderline resectable (per Al-Hawary MM, et al., Radiology 201414)
5. ECOG score 0-2
6. Amenable and assigned by the investigator to receive therapy with gemcitabine and nab-paclitaxel
7. Able to operate the NovoTTF-200T System independently or with the help of a caregiver
8. Signed informed consent form for the study protocol
Exclusion Criteria
2. Cancer requiring anti-tumor treatment within the 5 years before inclusion, excluding treated stage I prostate cancer, in situ cervical or uterus cancer, in situ breast cancer and non-melanomatous skin cancer.
3. Serious co-morbidities:
1. Clinically significant (as determined by the investigator) hematological, hepatic and renal dysfunction, defined as: Neutrophil count \< 1.5 x 10\^9/L and platelet count \< 100 x 10\^9/L; bilirubin \> 1.5 x Upper Limit of Normal (ULN); AST and/or ALT \> 2.5 x ULN; and serum creatinine \> 1.5 x ULN.
2. History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea).
3. History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial.
4. History of cerebrovascular accident (CVA) within 6 months prior to randomization or that is not stable.
5. Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol therapy.
6. History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent.
4. Concurrent anti-tumor therapy beyond gemcitabine and nab-paclitaxel
5. Implantable electronic medical devices in the torso, such as pacemakers
6. Known severe hypersensitivities to medical adhesives or hydrogel, or to one of the chemotherapies used in this trial.
7. Pregnancy or breast-feeding (female patients with reproductive potential and their partners must accept to use effective contraception throughout the entire study period and for 3 months after the end of treatment). All patients who are capable of becoming pregnant must take a pregnancy test which is negative within 72 hours before beginning treatment. The definition of effective contraception is left up to the decision of the investigator.
8. Unable to follow the protocol for medical, psychological, familial, geographic or other reasons.
9. Admitted to an institution by administrative or court order.
18 Years
ALL
No
Sponsors
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NovoCure Ltd.
INDUSTRY
Responsible Party
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Locations
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Grandview Medical Center, Cancer Center
Birmingham, Alabama, United States
Infirmary Cancer Care
Mobile, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Arizona Oncology Associates, PC- HOPE - US Oncology Research
Tucson, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
Pacific Cancer Medical Center
Anaheim, California, United States
Providence Medical Foundation
Fullerton, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Dignity Health - Mercy Cancer Centers
Sacramento, California, United States
Sutter Cancer Center Sacramento
Sacramento, California, United States
Ridley-Tree Cancer Center
Santa Barbara, California, United States
Adventist Health St. Helena - Martin-O'Neil Cancer Center (MOCC)
St. Helena, California, United States
Associated Neurologists of Southern Connecticut, P.C.
Milford, Connecticut, United States
Boca Raton Regional Hospital, Lynn Cancer Institute
Boca Raton, Florida, United States
Cancer Specialist of North Florida
Fleming Island, Florida, United States
Florida Cancer Specialists & Research Institute - Colonial Office
Fort Myers, Florida, United States
Mayo Clinic Hospital - Florida
Jacksonville, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
AdventHealth Neuro Oncology
Orlando, Florida, United States
BRCR Medical Center INC
Plantation, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
Florida Hospital Tampa
Tampa, Florida, United States
Piedmont Cancer Institute
Atlanta, Georgia, United States
Illinois Cancer Specialist - US Oncology Research
Arlington Heights, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Kansas Medical Cancer Center
Fairway, Kansas, United States
Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center)
Topeka, Kansas, United States
Saint Elizabeth Healthcare
Edgewood, Kentucky, United States
Norton Cancer Institute, Norton Healthcare Pavilion
Louisville, Kentucky, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Central Maine Medical Center, Clinical Research Department
Lewiston, Maine, United States
University of Maryland Comprehensive Cancer Center
Baltimore, Maryland, United States
Maryland Oncology Hematology, P.A - US Oncology Research
Columbia, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan, PC
Grand Rapids, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
MidAmerica Division
Kansas City, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
OptumCare Cancer Care
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Renown Regional Medical Center & Renown Institute for Cancer
Reno, Nevada, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
Kaleida Health
Buffalo, New York, United States
Bassett Medical Center
Cooperstown, New York, United States
New York Hospital Queens
Flushing, New York, United States
NYU Langone Arena Oncology
Lake Success, New York, United States
White Plains Hospital - Center for Cancer Care
White Plains, New York, United States
Novant Health Oncology Specialists
Winston-Salem, North Carolina, United States
Gabrail Cancer Research Center
Canton, Ohio, United States
Toledo Clinic Cancer Centers
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Willamette Valley Cancer Institute and Research Center - US Oncology Research
Eugene, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Vita Medical Associates, P.C.
Fountain Hill, Pennsylvania, United States
UT/Erlanger Oncology & Hematology
Chattanooga, Tennessee, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center - US Oncology Research
Beaumont, Texas, United States
Texas Oncology - Bedford - US Oncology Reasearch
Bedford, Texas, United States
Methodist Regional Cancer Center
Dallas, Texas, United States
Texas Oncology - Baylor - US Oncology Research
Dallas, Texas, United States
Texas Oncology - El Paso Cancer Treatment Center Gateway - US Oncology Research
El Paso, Texas, United States
Houston Methodist Cancer Center
Houston, Texas, United States
Baylor Scott and White Medical Center
Temple, Texas, United States
Texas Oncology - Tyler - US Oncology Research
Tyler, Texas, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - US Oncology Research
Roanoke, Virginia, United States
Vista Oncology Inc PS
Olympia, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
West Virginia University Cancer Institute
Morgantown, West Virginia, United States
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
St. John of God Murdoch Hospital
Murdoch, Western Australia, Australia
Monash Medical Centre
Clayton, , Australia
Sydney Adventist Hospital
Wahroonga, , Australia
Westmead Hosptial
Westmead, , Australia
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Wörthersee, Austria
Medical University Graz
Graz, , Austria
Univ. Klinik für Innere Medizin III der PMU
Salzburg, , Austria
Landes-Krankenhaus Steyr
Steyr, , Austria
Faculté de Médecine Campus Erasme
Anderlecht, , Belgium
UZ Leuven
Leuven, , Belgium
Clinique Universutaire Saint Luc - Institut Roi Albert II
Woluwe-Saint-Lambert, , Belgium
Centro de Pesquisa Clínica e Ensino Florianópolis LTDA
Florianópolis, , Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, , Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, , Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, , Brazil
Hospital São Lucas da PUCRS
Porto Alegre, , Brazil
IRPCc - Instituto Ribeirãopretano de Combate ao Câncer
Ribeirão Preto, , Brazil
Oncoclinicas Group Botafogo
Rio de Janeiro, , Brazil
Instituto D'Or de Pesquisa e Ensino - Rio De Janeiro
Rio de Janeiro, , Brazil
Groupo Clinicas Oncologicas Integradas (COI) - Barra da Tijuca
Rio de Janeiro, , Brazil
Instituto D´Or de Pesquisa e Ensino - Hospital São Rafael
São Marcos, , Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo
São Paulo, , Brazil
Clínica OncoStar - REDE D´OR
São Paulo, , Brazil
London Regional Cancer Program, London Health Sciences Centre
London, Ontario, Canada
Centre Hospitalier de I'Universitaire de de Montreal (CHUM)
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, Canada
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, China
Linyi Cancer Hospital
Linyi, Shandong, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Beijing Cancer Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Peking University People'S Hospital
Beijing, , China
The first hospital of Jilin University
Changchun, , China
Guangdong provincial people's hospital
Guangzhou, , China
Jilin Guowen Hospital
Jilin, , China
Shanghai Changhai Hospital
Shanghai, , China
Shanxi Provincial Cancer Hospital
Shanxi, , China
Xingtai People's Hospital
Xingtai, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Henan Provincial Peoples Hospital
Zhengzhou, , China
University Hospital Centre Zagreb
Zagreb, , Croatia
Masaryk Institute of Oncology
Brno střed, , Czechia
Nemocnice Nový Jičín
Nový Jičín, , Czechia
University Hospital Olomouc
Olomouc, , Czechia
General University Hospital in Prague
Prague, , Czechia
Nemocnice Na Bulovce
Prague, , Czechia
Hopital haut-Léveque CHU Bordeaux - Service d'Hépato- Gastroentérologie et d'Oncologie digestive
Pessac, Bordeaux, France
Centre Hospitalier de Bretagne Sud /Site du Scorff
Lorient, , France
Centre Léon Bérard
Lyon, , France
Service d'Oncologie médicale du Pr. Andre, Hôpital Saint-Antoine
Paris, , France
Hôpital Privé des Côtes d'Armor
Plérin, , France
Institut de Cancérologie de l'Ouest
Saint-Herblain, , France
Centre de Lutte Contre le Cancer (CLCC) - Centre Paul Strauss
Strasbourg, , France
Clinique Sainte Anne - Groupe Hospitalier Saint-Vincent, Strasbourg Oncologie Libérale
Strasbourg, , France
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Medizinische Hochschule Hannover, Klinik fur Gastroenterologie, Hepatologie und Endokrinologie
Hanover, , Germany
VK und K Studien GbR Landshut-Achdorf
Landshut, , Germany
Bonifatius Hospital Hematology and Oncology
Lingen, , Germany
Carl-von-Basedow-klinikum Saalekrei
Merseburg, , Germany
Klinikum München Bogenhausen, Klinik für Gastroenterologie und Gastroenterologische Onkologie
München, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
National Institute of Oncology
Budapest, , Hungary
Bekes County Hospital
Gyula, , Hungary
Bacs-Kiskun County Hospital
Kecskemét, , Hungary
Tolna County Hospital
Szekszárd, , Hungary
Jasz-Nagykun-Szolnok County Hospital
Szolnok, , Hungary
Rambam Health Care Campus, Oncology Institute
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sheba Pancreatic Cancer Center - SPCC
Ramat Gan, , Israel
Sourasky Medical Center, Oncology Department
Tel Aviv, , Israel
A.O. SS Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Università Campus Bio-Medico di Rome
Roma, , Italy
Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina
Roma, , Italy
A.O.U Città della Salute e della Scienza di Torino
Torino, , Italy
Mediadvance Clinical
Chihuahua City, Chih., Mexico
Accelerium S de RL de C.V.
Monterrey, Nuevo León, Mexico
Centro de Estudios de Alta Especialidad de Sinaloa, ubicado
Mazatlán, Sinaloa, Mexico
Centro de Investigación Médica Aguascalientes (CIMA),
Aguascalientes, , Mexico
Clinstile S.A. de C.V.,
Cuauhtémoc, , Mexico
Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlán Izcalli, , Mexico
Hospitales Star Medica - Luna Parc
Estado de México, , Mexico
Universidad Autonoma de Nuevo Leon - Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, , Mexico
Oncocenter - Puebla
Puebla City, , Mexico
Hospital Angeles San Luis
San Luis Potosí City, , Mexico
Centro Potosino de Investigación Médica SC,
San Luis Potosí City, , Mexico
Centro Hemato-Oncologico Privado CHOP
Toluca, , Mexico
Phylasis Clinicas Research S.de R.L. de C.V. (PCR)-Toluca
Toluca, , Mexico
FAICIC Clinical Research
Veracruz, , Mexico
Oncology Clinic Clinical Hospital of Przemienienia Pańskiego UM in Poznaniu
Poznan, , Poland
Centrum Medyczne MrukMed
Rzeszów, , Poland
Oncology and Radiotherapy Clinic, Oncology Center - Institute
Warsaw, , Poland
Oncology and Radiotherapy Clinic University Clinical Center Non-Invasive Medicine Center
Warsaw, , Poland
Jan Mikulicz-Radecki University Teaching Hospital
Wroclaw, , Poland
Dong-A University Hospital
Seogu, Busan, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Keimyung University, Dongsan hospital
Daegu, , South Korea
National Cancer Center
Gyeonggi-do, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Gachon University Gil Hospital
Incheon, , South Korea
Inha University Hospital
Incheon, , South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Instituto Oncòlogico Dr. Rosell
Barcelona, , Spain
Vall d´Hebron University Hospital
Barcelona, , Spain
Hospital General Universitario de Elche
Elche, , Spain
HM Hospitales - Centro Integral Oncologico Clara Campal - CIOCC
Madrid, , Spain
Hospital Universitario Ramon Y Cajal Carretera de Colmenar Viejo
Madrid, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Clinica Universiatria de Navarra
Pamplona, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Instituto Valenciano de Oncología IVO
Valencia, , Spain
Hôpital Fribourgeois/Freiburger Spital
Fribourg, , Switzerland
KS Winterthur
Winterthur, , Switzerland
Countries
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References
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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.
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.
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.
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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EF-27
Identifier Type: -
Identifier Source: org_study_id
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