NCT03377491

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
571

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2018

Longer than P75 for phase_3

Geographic Reach
19 countries

195 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

May 10, 2018

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 21, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

6.4 years

First QC Date

December 6, 2017

Results QC Date

October 15, 2025

Last Update Submit

January 1, 2026

Conditions

Keywords

Locally Advanced Pancreatic AdenocarcinomaTTFieldsTumor Treating FieldsGemcitabinenab-PaclitaxelMinimal toxicityTTFNovocure

Outcome Measures

Primary Outcomes (1)

  • Overall Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone

    Overall survival of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to overall survival of subjects treated with chemotherapy alone, measured as the period between the time of randomization and the time of death.

    From randomization until death from any cause or last known alive.

Secondary Outcomes (8)

  • Progression-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone

    From randomization until radiologic disease progression per RECIST v1.1 or death, whichever occurs first.

  • Local Progression-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone

    From randomization until local disease progression per RECIST v1.1 (in the absence of distant metastasis) or death, whichever occurs first.

  • Objective Response Rate of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone

    From randomization until radiologic disease progression per RECIST v1.1 or end of tumor assessment follow-up.

  • One-year Survival Rate of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone

    From randomization through 12 months after randomization.

  • Quality of Life of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone

    From randomization until the first ≥10-point deterioration without subsequent improvement, or death, assessed for the duration of study follow-up.

  • +3 more secondary outcomes

Study Arms (2)

NovoTTF-200T

EXPERIMENTAL

Patients receive TTFields using the NovoTTF-200T System together with gemcitabine and nab-Paclitaxel

Device: NovoTTF-200TDrug: GemcitabineDrug: nab paclitaxel

Best Standard of Care

ACTIVE COMPARATOR

Patients receive best standard of care with gemcitabine and nab-Paclitaxel

Drug: GemcitabineDrug: nab paclitaxel

Interventions

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.

Also known as: TTFields
NovoTTF-200T

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.

Best Standard of CareNovoTTF-200T

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 CareNovoTTF-200T

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older
  • Life expectancy of ≥ 3 months
  • Histological/cytological diagnosis of de novo adenocarcinoma of the pancreas
  • Unresectable, locally advanced stage disease according to the following criteria:
  • Head/uncinate process:
  • Solid tumor contact with SMA\>180°
  • Solid tumor contact with the CA\>180°
  • Solid tumor contact with the first jejunal SMA branch
  • Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t tumor or bland thrombus)
  • Contact with most proximal draining jejunal branch into SMV
  • Body and tail
  • Solid tumor contact of \>180° with the SMA or CA
  • Solid tumor contact with the CA and aortic involvement
  • 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
  • +5 more criteria

You may not qualify if:

  • Prior palliative treatment (e.g. surgery, radiation) to the tumor
  • Serious co-morbidities:
  • 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.
  • 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).
  • 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.
  • History of cerebrovascular accident (CVA) within 6 months prior to randomization or that is not stable.
  • Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol therapy.
  • 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.
  • Concurrent anti-tumor therapy beyond gemcitabine and nab-paclitaxel
  • Implantable electronic medical devices in the torso, such as pacemakers
  • Known severe hypersensitivities to medical adhesives or hydrogel, or to one of the chemotherapies used in this trial.
  • 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.
  • Unable to follow the protocol for medical, psychological, familial, geographic or other reasons.
  • Admitted to an institution by administrative or court order.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (199)

Grandview Medical Center, Cancer Center

Birmingham, Alabama, 35243, United States

Location

Infirmary Cancer Care

Mobile, Alabama, 36607, United States

Location

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Arizona Oncology Associates, PC- HOPE - US Oncology Research

Tucson, Arizona, 85711, United States

Location

University of Arizona Cancer Center

Tucson, Arizona, 85724-5024, United States

Location

Pacific Cancer Medical Center

Anaheim, California, 92801, United States

Location

Providence Medical Foundation

Fullerton, California, 92835, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Dignity Health - Mercy Cancer Centers

Sacramento, California, 95816, United States

Location

Sutter Cancer Center Sacramento

Sacramento, California, 95816, United States

Location

Ridley-Tree Cancer Center

Santa Barbara, California, 93105, United States

Location

Adventist Health St. Helena - Martin-O'Neil Cancer Center (MOCC)

St. Helena, California, 94574, United States

Location

Associated Neurologists of Southern Connecticut, P.C.

Milford, Connecticut, 06460, United States

Location

Boca Raton Regional Hospital, Lynn Cancer Institute

Boca Raton, Florida, 33486, United States

Location

Cancer Specialist of North Florida

Fleming Island, Florida, 32003, United States

Location

Florida Cancer Specialists & Research Institute - Colonial Office

Fort Myers, Florida, 33905, United States

Location

Mayo Clinic Hospital - Florida

Jacksonville, Florida, 32224, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

AdventHealth Neuro Oncology

Orlando, Florida, 32804, United States

Location

BRCR Medical Center INC

Plantation, Florida, 33324, United States

Location

Florida Cancer Specialists

St. Petersburg, Florida, 33705, United States

Location

Florida Hospital Tampa

Tampa, Florida, 33613, United States

Location

Piedmont Cancer Institute

Atlanta, Georgia, 30318, United States

Location

Illinois Cancer Specialist - US Oncology Research

Arlington Heights, Illinois, 60005, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Kansas Medical Cancer Center

Fairway, Kansas, 66205, United States

Location

Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center)

Topeka, Kansas, 66606, United States

Location

Saint Elizabeth Healthcare

Edgewood, Kentucky, 41017, United States

Location

Norton Cancer Institute, Norton Healthcare Pavilion

Louisville, Kentucky, 40202, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Central Maine Medical Center, Clinical Research Department

Lewiston, Maine, 04240, United States

Location

University of Maryland Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

Location

Maryland Oncology Hematology, P.A - US Oncology Research

Columbia, Maryland, 21044, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01605, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Cancer and Hematology Centers of Western Michigan, PC

Grand Rapids, Michigan, 49503, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MidAmerica Division

Kansas City, Missouri, 64132, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

OptumCare Cancer Care

Las Vegas, Nevada, 89102, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89619, United States

Location

Renown Regional Medical Center & Renown Institute for Cancer

Reno, Nevada, 89502, United States

Location

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

Location

Kaleida Health

Buffalo, New York, 14210, United States

Location

Bassett Medical Center

Cooperstown, New York, 13326, United States

Location

New York Hospital Queens

Flushing, New York, 11355, United States

Location

NYU Langone Arena Oncology

Lake Success, New York, 11042, United States

Location

White Plains Hospital - Center for Cancer Care

White Plains, New York, 10601, United States

Location

Novant Health Oncology Specialists

Winston-Salem, North Carolina, 27103, United States

Location

Gabrail Cancer Research Center

Canton, Ohio, 44718, United States

Location

Toledo Clinic Cancer Centers

Toledo, Ohio, 44614, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Willamette Valley Cancer Institute and Research Center - US Oncology Research

Eugene, Oregon, 97401, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Vita Medical Associates, P.C.

Fountain Hill, Pennsylvania, 18015, United States

Location

UT/Erlanger Oncology & Hematology

Chattanooga, Tennessee, 37403, United States

Location

Tennessee Cancer Specialists

Knoxville, Tennessee, 37909-1327, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center - US Oncology Research

Beaumont, Texas, 77702, United States

Location

Texas Oncology - Bedford - US Oncology Reasearch

Bedford, Texas, 76022, United States

Location

Methodist Regional Cancer Center

Dallas, Texas, 75203, United States

Location

Texas Oncology - Baylor - US Oncology Research

Dallas, Texas, 75246, United States

Location

Texas Oncology - El Paso Cancer Treatment Center Gateway - US Oncology Research

El Paso, Texas, 79915, United States

Location

Houston Methodist Cancer Center

Houston, Texas, 77030, United States

Location

Baylor Scott and White Medical Center

Temple, Texas, 76508, United States

Location

Texas Oncology - Tyler - US Oncology Research

Tyler, Texas, 75702, United States

Location

Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - US Oncology Research

Roanoke, Virginia, 24014, United States

Location

Vista Oncology Inc PS

Olympia, Washington, 98506, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

West Virginia University Cancer Institute

Morgantown, West Virginia, 26506, United States

Location

Greenslopes Private Hospital

Greenslopes, Queensland, 4120, Australia

Location

St. John of God Murdoch Hospital

Murdoch, Western Australia, 6150, Australia

Location

Monash Medical Centre

Clayton, VIC 3168, Australia

Location

Sydney Adventist Hospital

Wahroonga, NSW 2076, Australia

Location

Westmead Hosptial

Westmead, NSW 2145, Australia

Location

Klinikum Klagenfurt am Wörthersee

Klagenfurt, Wörthersee, 9020, Austria

Location

Medical University Graz

Graz, 17070, Austria

Location

Univ. Klinik für Innere Medizin III der PMU

Salzburg, 5020, Austria

Location

Landes-Krankenhaus Steyr

Steyr, 4400, Austria

Location

Faculté de Médecine Campus Erasme

Anderlecht, 1070, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Clinique Universutaire Saint Luc - Institut Roi Albert II

Woluwe-Saint-Lambert, 1200, Belgium

Location

Centro de Pesquisa Clínica e Ensino Florianópolis LTDA

Florianópolis, 88020, Brazil

Location

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, 98700, Brazil

Location

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, 90020-090, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, 90035, Brazil

Location

Hospital São Lucas da PUCRS

Porto Alegre, 90610, Brazil

Location

IRPCc - Instituto Ribeirãopretano de Combate ao Câncer

Ribeirão Preto, 14015-130, Brazil

Location

Oncoclinicas Group Botafogo

Rio de Janeiro, 22250-040, Brazil

Location

Instituto D'Or de Pesquisa e Ensino - Rio De Janeiro

Rio de Janeiro, 22271, Brazil

Location

Groupo Clinicas Oncologicas Integradas (COI) - Barra da Tijuca

Rio de Janeiro, 22775-001, Brazil

Location

Instituto D´Or de Pesquisa e Ensino - Hospital São Rafael

São Marcos, 41253-190, Brazil

Location

Núcleo de Pesquisa Clínica da Rede São Camilo

São Paulo, 04014-002, Brazil

Location

Clínica OncoStar - REDE D´OR

São Paulo, 04543, Brazil

Location

London Regional Cancer Program, London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Centre Hospitalier de I'Universitaire de de Montreal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, J1G 1B1, Canada

Location

Sun Yat-sen Memorial Hospital Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150086, China

Location

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430014, China

Location

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Linyi Cancer Hospital

Linyi, Shandong, 276000, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

Peking University People'S Hospital

Beijing, China

Location

The first hospital of Jilin University

Changchun, 130021, China

Location

Guangdong provincial people's hospital

Guangzhou, 510000, China

Location

Jilin Guowen Hospital

Jilin, 136100, China

Location

Shanghai Changhai Hospital

Shanghai, 200433, China

Location

Shanxi Provincial Cancer Hospital

Shanxi, 030013, China

Location

Xingtai People's Hospital

Xingtai, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, 450052, China

Location

Henan Provincial Peoples Hospital

Zhengzhou, China

Location

University Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

Masaryk Institute of Oncology

Brno-střed, 60200, Czechia

Location

Nemocnice Nový Jičín

Nový Jičín, 741 01, Czechia

Location

University Hospital Olomouc

Olomouc, 779 00, Czechia

Location

General University Hospital in Prague

Prague, 128 08, Czechia

Location

Nemocnice Na Bulovce

Prague, 180 81, Czechia

Location

Hopital haut-Léveque CHU Bordeaux - Service d'Hépato- Gastroentérologie et d'Oncologie digestive

Pessac, Bordeaux, 33604, France

Location

Centre Hospitalier de Bretagne Sud /Site du Scorff

Lorient, 56322, France

Location

Centre Léon Bérard

Lyon, France

Location

Service d'Oncologie médicale du Pr. Andre, Hôpital Saint-Antoine

Paris, 75012, France

Location

Hôpital Privé des Côtes d'Armor

Plérin, 22190, France

Location

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44805, France

Location

Centre de Lutte Contre le Cancer (CLCC) - Centre Paul Strauss

Strasbourg, 67000, France

Location

Clinique Sainte Anne - Groupe Hospitalier Saint-Vincent, Strasbourg Oncologie Libérale

Strasbourg, 67000, France

Location

Klinikum Chemnitz gGmbH

Chemnitz, 09116, Germany

Location

Medizinische Hochschule Hannover, Klinik fur Gastroenterologie, Hepatologie und Endokrinologie

Hanover, Germany

Location

VK und K Studien GbR Landshut-Achdorf

Landshut, 84036, Germany

Location

Bonifatius Hospital Hematology and Oncology

Lingen, 49808, Germany

Location

Carl-von-Basedow-klinikum Saalekrei

Merseburg, 06217, Germany

Location

Klinikum München Bogenhausen, Klinik für Gastroenterologie und Gastroenterologische Onkologie

München, 81925, Germany

Location

Universitätsklinikum Ulm

Ulm, D-89081, Germany

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

National Institute of Oncology

Budapest, 1122, Hungary

Location

Bekes County Hospital

Gyula, 5700, Hungary

Location

Bacs-Kiskun County Hospital

Kecskemét, 6000, Hungary

Location

Tolna County Hospital

Szekszárd, 7100, Hungary

Location

Jasz-Nagykun-Szolnok County Hospital

Szolnok, 5000, Hungary

Location

Rambam Health Care Campus, Oncology Institute

Haifa, 3109601, Israel

Location

Hadassah Medical Center

Jerusalem, 9112000, Israel

Location

Rabin Medical Center

Petah Tikva, 4941492, Israel

Location

Sheba Pancreatic Cancer Center - SPCC

Ramat Gan, Israel

Location

Sourasky Medical Center, Oncology Department

Tel Aviv, 64239, Israel

Location

A.O. SS Antonio e Biagio e Cesare Arrigo

Alessandria, 15121, Italy

Location

Azienda Ospedaliero-Universitaria Careggi

Florence, 50134, Italy

Location

Università Campus Bio-Medico di Rome

Roma, 00128, Italy

Location

Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina

Roma, 00186, Italy

Location

A.O.U Città della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Mediadvance Clinical

Chihuahua City, Chih., 31210, Mexico

Location

Accelerium S de RL de C.V.

Monterrey, Nuevo León, 64000, Mexico

Location

Centro de Estudios de Alta Especialidad de Sinaloa, ubicado

Mazatlán, Sinaloa, 82110, Mexico

Location

Centro de Investigación Médica Aguascalientes (CIMA),

Aguascalientes, 20116, Mexico

Location

Clinstile S.A. de C.V.,

Cuauhtémoc, 06700, Mexico

Location

Phylasis Clinicas Research S. de R.L. de C.V.

Cuautitlán Izcalli, 54769, Mexico

Location

Hospitales Star Medica - Luna Parc

Estado de México, 54750, Mexico

Location

Universidad Autonoma de Nuevo Leon - Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, 64460, Mexico

Location

Oncocenter - Puebla

Puebla City, 72530, Mexico

Location

Hospital Angeles San Luis

San Luis Potosí City, 78200, Mexico

Location

Centro Potosino de Investigación Médica SC,

San Luis Potosí City, 78250, Mexico

Location

Centro Hemato-Oncologico Privado CHOP

Toluca, 50080, Mexico

Location

Phylasis Clinicas Research S.de R.L. de C.V. (PCR)-Toluca

Toluca, 50180, Mexico

Location

FAICIC Clinical Research

Veracruz, 91900, Mexico

Location

Oncology Clinic Clinical Hospital of Przemienienia Pańskiego UM in Poznaniu

Poznan, 60-596, Poland

Location

Centrum Medyczne MrukMed

Rzeszów, 35-021, Poland

Location

Oncology and Radiotherapy Clinic, Oncology Center - Institute

Warsaw, 02-034, Poland

Location

Oncology and Radiotherapy Clinic University Clinical Center Non-Invasive Medicine Center

Warsaw, 02-507, Poland

Location

Jan Mikulicz-Radecki University Teaching Hospital

Wroclaw, 50-556, Poland

Location

Dong-A University Hospital

Seogu, Busan, 602-715, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Keimyung University, Dongsan hospital

Daegu, 42601, South Korea

Location

National Cancer Center

Gyeonggi-do, 10408, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun, 58128, South Korea

Location

Gachon University Gil Hospital

Incheon, 21565, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

CHA Bundang Medical Center, CHA University

Seongnam-si, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

Instituto Oncòlogico Dr. Rosell

Barcelona, 08028, Spain

Location

Vall d´Hebron University Hospital

Barcelona, Spain

Location

Hospital General Universitario de Elche

Elche, Spain

Location

HM Hospitales - Centro Integral Oncologico Clara Campal - CIOCC

Madrid, 28050, Spain

Location

Hospital Universitario Ramon Y Cajal Carretera de Colmenar Viejo

Madrid, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, 29010, Spain

Location

Clinica Universiatria de Navarra

Pamplona, 31008, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Location

Instituto Valenciano de Oncología IVO

Valencia, 46009, Spain

Location

Hôpital Fribourgeois/Freiburger Spital

Fribourg, 1708, Switzerland

Location

KS Winterthur

Winterthur, 8401, Switzerland

Location

Related Publications (9)

  • 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.

    PMID: 15126372BACKGROUND
  • 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.

    PMID: 17551011BACKGROUND
  • 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.

    PMID: 22608262BACKGROUND
  • 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.

    PMID: 19387848BACKGROUND
  • Giladi M, Schneiderman RS, Voloshin T, Porat Y, Munster M, Blat R, Sherbo S, Bomzon Z, Urman N, Itzhaki A, Cahal S, Shteingauz A, Chaudhry A, Kirson ED, Weinberg U, Palti Y. Mitotic Spindle Disruption by Alternating Electric Fields Leads to Improper Chromosome Segregation and Mitotic Catastrophe in Cancer Cells. Sci Rep. 2015 Dec 11;5:18046. doi: 10.1038/srep18046.

    PMID: 26658786BACKGROUND
  • Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.

    PMID: 26670971BACKGROUND
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  • Stupp R, Taillibert S, Kanner A, Read W, Steinberg D, Lhermitte B, Toms S, Idbaih A, Ahluwalia MS, Fink K, Di Meco F, Lieberman F, Zhu JJ, Stragliotto G, Tran D, Brem S, Hottinger A, Kirson ED, Lavy-Shahaf G, Weinberg U, Kim CY, Paek SH, Nicholas G, Bruna J, Hirte H, Weller M, Palti Y, Hegi ME, Ram Z. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2306-2316. doi: 10.1001/jama.2017.18718.

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MeSH Terms

Interventions

GemcitabineTaxes

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingEconomicsHealth Care Economics and Organizations

Results Point of Contact

Title
Medical Director
Organization
Novocure

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2017

First Posted

December 19, 2017

Study Start

May 10, 2018

Primary Completion

October 16, 2024

Study Completion

October 16, 2024

Last Updated

January 21, 2026

Results First Posted

January 21, 2026

Record last verified: 2026-01

Locations