Clinical trial NCT03377491: 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)
Official title: Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Gemcitabine and Nab-paclitaxel for Front-line Treatment of Locally-advanced Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreas Adenocarcinoma
Keywords: Locally Advanced Pancreatic Adenocarcinoma
TTFields
Tumor Treating Fields
Gemcitabine
nab-Paclitaxel
Minimal toxicity
TTF
Novocure
Lead sponsor: NovoCure Ltd.
Sponsor class: INDUSTRY
First posted: 2017-12-19
Enrollment: 571
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Brief Summary:

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.

Detailed description: PAST PRE-CLINICAL AND CLINICAL EXPERIENCE:

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.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age and older
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:

1. Prior palliative treatment (e.g. surgery, radiation) to the tumor
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.

Primary outcomes:
measure: Overall survival
timeFrame: 4 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 4 years
measure: Local progression-free survival
timeFrame: 4 years
measure: Objective response rate
timeFrame: 4 years
measure: One-year survival rate
timeFrame: 4 years
measure: Quality of life
timeFrame: 4 years
measure: Pain-free survival
timeFrame: 4 years
measure: Puncture-free survival
timeFrame: 4 years
measure: Resectability rate
timeFrame: 4 years
measure: Toxicity profile
timeFrame: 4 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center, Cancer Center
state: Alabama
city: Mobile
country: United States
facility: Infirmary Cancer Care
state: Alabama
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC- HOPE - US Oncology Research
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center
state: California
city: Fullerton
country: United States
facility: St. Joseph Heritage Healthcare - Virginia K. Crosson Cancer Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: Dignity Health - Mercy Cancer Centers
state: California
city: Sacramento
country: United States
facility: Sutter Cancer Center Sacramento
state: California
city: Saint Helena
country: United States
facility: Adventist Health St. Helena - Martin-O'Neil Cancer Center (MOCC)
state: California
city: Santa Barbara
country: United States
facility: Ridley-Tree Cancer Center
state: California
city: Milford
country: United States
facility: Associated Neurologists of Southern Connecticut, P.C.
state: Connecticut
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital, Lynn Cancer Institute
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists & Research Institute - Colonial Office
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Hospital - Florida
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Orlando
country: United States
facility: AdventHealth Neuro Oncology
state: Florida
city: Plantation
country: United States
facility: BRCR Medical Center INC
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tampa
country: United States
facility: Florida Hospital Tampa
state: Florida
city: Atlanta
country: United States
facility: Piedmont Cancer Institute
state: Georgia
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialist - US Oncology Research
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Fairway
country: United States
facility: University of Kansas Medical Cancer Center
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center)
state: Kansas
city: Edgewood
country: United States
facility: Saint Elizabeth Healthcare
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute, Norton Healthcare Pavilion
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Lewiston
country: United States
facility: Central Maine Medical Center, Clinical Research Department
state: Maine
city: Baltimore
country: United States
facility: University of Maryland Comprehensive Cancer Center
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology Hematology, P.A - US Oncology Research
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan, PC
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: MidAmerica Division
state: Missouri
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Las Vegas
country: United States
facility: OptumCare Cancer Care
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Reno
country: United States
facility: Renown Institute for Heart & Vascular Health
state: Nevada
city: East Brunswick
country: United States
facility: Astera Cancer Care
state: New Jersey
city: Buffalo
country: United States
facility: Kaleida Health
state: New York
city: Cooperstown
country: United States
facility: Bassett Medical Center
state: New York
city: Flushing
country: United States
facility: New York Hospital Queens
state: New York
city: Lake Success
country: United States
facility: NYU Langone Arena Oncology
state: New York
city: White Plains
country: United States
facility: White Plains Hospital - Center for Cancer Care
state: New York
city: Winston-Salem
country: United States
facility: Novant Health Oncology Specialists
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Research Center
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic Cancer Centers
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center - US Oncology Research
state: Oregon
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Fountain Hill
country: United States
facility: Vita Medical Associates, P.C.
state: Pennsylvania
city: Chattanooga
country: United States
facility: UT/Erlanger Oncology & Hematology
state: Tennessee
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Beaumont
country: United States
facility: Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center - US Oncology Research
state: Texas
city: Bedford
country: United States
facility: Texas Oncology - Bedford - US Oncology Reasearch
state: Texas
city: Dallas
country: United States
facility: Methodist Regional Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Baylor - US Oncology Research
state: Texas
city: El Paso
country: United States
facility: Texas Oncology - El Paso Cancer Treatment Center Gateway - US Oncology Research
state: Texas
city: Houston
country: United States
facility: Houston Methodist Cancer Center
state: Texas
city: Temple
country: United States
facility: Baylor Scott and White Medical Center
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler - US Oncology Research
state: Texas
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - US Oncology Research
state: Virginia
city: Olympia
country: United States
facility: Vista Oncology Inc PS
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Cancer Institute
state: West Virginia
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital
state: Queensland
city: Murdoch
country: Australia
facility: St. John of God Murdoch Hospital
state: Western Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
city: Westmead
country: Australia
facility: Westmead Hosptial
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
state: Wörthersee
city: Graz
country: Austria
facility: Medical University Graz
city: Salzburg
country: Austria
facility: Univ. Klinik für Innere Medizin III der PMU
city: Steyr
country: Austria
facility: Landes-Krankenhaus Steyr
city: Anderlecht
country: Belgium
facility: Faculté de Médecine Campus Erasme
city: Leuven
country: Belgium
facility: UZ Leuven
city: Woluwe-Saint-Lambert
country: Belgium
facility: Clinique Universutaire Saint Luc - Institut Roi Albert II
city: Florianópolis
country: Brazil
facility: Centro de Pesquisa Clínica e Ensino Florianópolis LTDA
city: Ijuí
country: Brazil
facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
city: Ribeirão Preto
country: Brazil
facility: IRPCc - Instituto Ribeirãopretano de Combate ao Câncer
city: Rio De Janeiro
country: Brazil
facility: Oncoclinicas Group Botafogo
city: Rio De Janeiro
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino - Rio De Janeiro
city: Rio De Janeiro
country: Brazil
facility: Groupo Clinicas Oncologicas Integradas (COI) - Barra da Tijuca
city: São Marcos
country: Brazil
facility: Instituto D´Or de Pesquisa e Ensino - Hospital São Rafael
city: São Marcos
country: Brazil
facility: Hospital São Rafael
city: São Paulo
country: Brazil
facility: Núcleo de Pesquisa Clínica da Rede São Camilo
city: São Paulo
country: Brazil
facility: Onco Star SP Oncologia LTDA
city: São Paulo
country: Brazil
facility: Clínica OncoStar - REDE D´OR
city: London
country: Canada
facility: London Regional Cancer Program, London Health Sciences Centre
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de I'Universitaire de de Montreal (CHUM)
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke CIUSSS de l'Estrie - CHUS
state: Quebec
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital Sun Yat-sen University
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Wuhan
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi 'an Jiaotong University
state: Shaanxi
city: Linyi
country: China
facility: Linyi Cancer Hospital
state: Shandong
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University People'S Hospital
city: Changchun
country: China
facility: The first hospital of Jilin University
city: Guangzhou
country: China
facility: Guangdong provincial people's hospital
city: Jilin
country: China
facility: Jilin Guowen Hospital
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
city: Shanxi
country: China
facility: Shanxi Provincial Cancer Hospital
city: Xingtai
country: China
facility: Xingtai People's Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Zhengzhou
country: China
facility: Henan Provincial Peoples Hospital
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb
city: Brno Střed
country: Czechia
facility: Masaryk Institute of Oncology
city: Nový Jičín
country: Czechia
facility: Nemocnice Nový Jičín
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Praha 2
country: Czechia
facility: General University Hospital in Prague
city: Praha 8
country: Czechia
facility: Nemocnice Na Bulovce
city: Pessac
country: France
facility: Hopital haut-Léveque CHU Bordeaux - Service d'Hépato- Gastroentérologie et d'Oncologie digestive
state: Bordeaux
city: Angers cedex
country: France
facility: Institut de Cancérologie de l'Ouest
city: Lorient
country: France
facility: Centre Hospitalier de Bretagne Sud /Site du Scorff
city: Lyon
country: France
facility: Centre Léon Bérard
city: Paris
country: France
facility: Service d'Oncologie médicale du Pr. Andre, Hôpital Saint-Antoine
city: Plérin
country: France
facility: Hôpital Privé des Côtes d'Armor
city: Strasbourg
country: France
facility: Centre de Lutte Contre le Cancer (CLCC) - Centre Paul Strauss
city: Strasbourg
country: France
facility: Clinique Sainte Anne - Groupe Hospitalier Saint-Vincent, Strasbourg Oncologie Libérale
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Klinik fur Gastroenterologie, Hepatologie und Endokrinologie
city: Landshut
country: Germany
facility: VK und K Studien GbR Landshut-Achdorf
city: Lingen
country: Germany
facility: Bonifatius Hospital Hematology and Oncology
city: Merseburg
country: Germany
facility: Carl-von-Basedow-klinikum Saalekrei
city: München
country: Germany
facility: Klinikum München Bogenhausen, Klinik für Gastroenterologie und Gastroenterologische Onkologie
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Gyula
country: Hungary
facility: Bekes County Hospital
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun County Hospital
city: Szekszárd
country: Hungary
facility: Tolna County Hospital
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok County Hospital
city: Haifa
country: Israel
facility: Rambam Health Care Campus, Oncology Institute
city: Petah tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Hadassah Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Pancreatic Cancer Center - SPCC
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center, Oncology Department
city: Alessandria
country: Italy
facility: A.O. SS Antonio e Biagio e Cesare Arrigo
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Roma
country: Italy
facility: Università Campus Bio-Medico di Rome
city: Roma
country: Italy
facility: Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina
city: Torino
country: Italy
facility: A.O.U Città della Salute e della Scienza di Torino
city: Seogu
country: Korea, Republic of
facility: Dong-A University Hospital
state: Busan
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Keimyung University, Dongsan hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Chihuahua
country: Mexico
facility: Mediadvance Clinical
state: Chih.
city: Monterrey
country: Mexico
facility: Accelerium S de RL de C.V.
state: NL
city: Mazatlán
country: Mexico
facility: Centro de Estudios de Alta Especialidad de Sinaloa, ubicado
state: Sinaloa
city: Aguascalientes
country: Mexico
facility: Centro de Investigación Médica Aguascalientes (CIMA),
city: Cuauhtémoc
country: Mexico
facility: Clinstile S.A. de C.V.,
city: Cuautitlán Izcalli
country: Mexico
facility: Phylasis Clinicas Research S. de R.L. de C.V.
city: Estado De México
country: Mexico
facility: Hospitales Star Medica - Luna Parc
city: Monterrey
country: Mexico
facility: Universidad Autonoma de Nuevo Leon - Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
city: Puebla
country: Mexico
facility: Oncocenter - Puebla
city: San Luis Potosí
country: Mexico
facility: Hospital Angeles San Luis
city: San Luis Potosí
country: Mexico
facility: Centro Potosino de Investigación Médica SC,
city: Toluca de Lerdo
country: Mexico
facility: Centro Hemato-Oncologico Privado CHOP
city: Toluca De Lerdo
country: Mexico
facility: Phylasis Clinicas Research S.de R.L. de C.V. (PCR)-Toluca
city: Veracruz
country: Mexico
facility: FAICIC Clinical Research
city: Poznań
country: Poland
facility: Oncology Clinic Clinical Hospital of Przemienienia Pańskiego UM in Poznaniu
city: Rzeszów
country: Poland
facility: Centrum Medyczne MrukMed
city: Warsaw
country: Poland
facility: Oncology and Radiotherapy Clinic, Oncology Center - Institute
city: Warsaw
country: Poland
facility: Oncology and Radiotherapy Clinic University Clinical Center Non-Invasive Medicine Center
city: Wrocław
country: Poland
facility: Jan Mikulicz-Radecki University Teaching Hospital
city: Barcelona
country: Spain
facility: Instituto Oncòlogico Dr. Rosell
city: Barcelona
country: Spain
facility: Vall d´Hebron University Hospital
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Madrid
country: Spain
facility: HM Hospitales - Centro Integral Oncologico Clara Campal - CIOCC
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Pamplona
country: Spain
facility: Clinica Universiatria de Navarra
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología IVO
city: Fribourg
country: Switzerland
facility: Hôpital Fribourgeois/Freiburger Spital
city: Winterthur
country: Switzerland
facility: KS Winterthur
Study officials:
References:
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citation: Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.
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citation: Giladi M, Schneiderman RS, Porat Y, Munster M, Itzhaki A, Mordechovich D, Cahal S, Kirson ED, Weinberg U, Palti Y. Mitotic disruption and reduced clonogenicity of pancreatic cancer cells in vitro and in vivo by tumor treating fields. Pancreatology. 2014 Jan-Feb;14(1):54-63. doi: 10.1016/j.pan.2013.11.009. Epub 2013 Dec 4.
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