AzTrials
AzTrials

Pancreas AdenocarcinomaPhase 3NCT03377491

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)

A Phase 3 study testing NovoTTF-200T, Gemcitabine and nab paclitaxel in people with Pancreas Adenocarcinoma, run by NovoCure Ltd. at 199 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreas Adenocarcinoma
What is being tested?
NovoTTF-200T, Gemcitabine and nab paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
571 participants
Where
199 sitesin 20 countries
Study dates
10 May 2018to 16 Oct 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 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°
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  • 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
  • No borderline resectable (per Al-Hawary MM, et al., Radiology 201414)
  • ECOG score 0-2
  • Amenable and assigned by the investigator to receive therapy with gemcitabine and nab-paclitaxel
  • Able to operate the NovoTTF-200T System independently or with the help of a caregiver
  • Signed informed consent form for the study protocol

Who cannot join

  • Prior palliative treatment (e.g. surgery, radiation) to the tumor
  • 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.
  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

199 sites in 20 countries.

199 sites in 20 countries

United States74 sites

  • Pacific Cancer Medical Center

    Anaheim, California, 92801

  • Illinois Cancer Specialist - US Oncology Research

    Arlington Heights, Illinois, 60005

  • Piedmont Cancer Institute

    Atlanta, Georgia, 30318

  • University of Maryland Comprehensive Cancer Center

    Baltimore, Maryland, 21201

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

    Beaumont, Texas, 77702

  • Texas Oncology - Bedford - US Oncology Reasearch

    Bedford, Texas, 76022

  • Grandview Medical Center, Cancer Center

    Birmingham, Alabama, 35243

  • Boca Raton Regional Hospital, Lynn Cancer Institute

    Boca Raton, Florida, 33486

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Kaleida Health

    Buffalo, New York, 14210

  • Gabrail Cancer Research Center

    Canton, Ohio, 44718

  • UT/Erlanger Oncology & Hematology

    Chattanooga, Tennessee, 37403

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Maryland Oncology Hematology, P.A - US Oncology Research

    Columbia, Maryland, 21044

  • Bassett Medical Center

    Cooperstown, New York, 13326

  • Methodist Regional Cancer Center

    Dallas, Texas, 75203

  • Texas Oncology - Baylor - US Oncology Research

    Dallas, Texas, 75246

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

  • Saint Elizabeth Healthcare

    Edgewood, Kentucky, 41017

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

    El Paso, Texas, 79915

  • Willamette Valley Cancer Institute and Research Center - US Oncology Research

    Eugene, Oregon, 97401

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201

  • University of Kansas Medical Cancer Center

    Fairway, Kansas, 66205

  • Cancer Specialist of North Florida

    Fleming Island, Florida, 32003

  • New York Hospital Queens

    Flushing, New York, 11355

  • Florida Cancer Specialists & Research Institute - Colonial Office

    Fort Myers, Florida, 33905

  • Vita Medical Associates, P.C.

    Fountain Hill, Pennsylvania, 18015

  • Providence Medical Foundation

    Fullerton, California, 92835

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Cancer and Hematology Centers of Western Michigan, PC

    Grand Rapids, Michigan, 49503

  • Houston Methodist Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic Hospital - Florida

    Jacksonville, Florida, 32224

  • MidAmerica Division

    Kansas City, Missouri, 64132

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909-1327

  • NYU Langone Arena Oncology

    Lake Success, New York, 11042

  • OptumCare Cancer Care

    Las Vegas, Nevada, 89102

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89619

  • Central Maine Medical Center, Clinical Research Department

    Lewiston, Maine, 04240

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Norton Cancer Institute, Norton Healthcare Pavilion

    Louisville, Kentucky, 40202

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Associated Neurologists of Southern Connecticut, P.C.

    Milford, Connecticut, 06460

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Infirmary Cancer Care

    Mobile, Alabama, 36607

  • West Virginia University Cancer Institute

    Morgantown, West Virginia, 26506

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Vista Oncology Inc PS

    Olympia, Washington, 98506

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • AdventHealth Neuro Oncology

    Orlando, Florida, 32804

  • BRCR Medical Center INC

    Plantation, Florida, 33324

  • Renown Regional Medical Center & Renown Institute for Cancer

    Reno, Nevada, 89502

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

    Roanoke, Virginia, 24014

  • Dignity Health - Mercy Cancer Centers

    Sacramento, California, 95816

  • Sutter Cancer Center Sacramento

    Sacramento, California, 95816

  • Ridley-Tree Cancer Center

    Santa Barbara, California, 93105

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

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

    St. Helena, California, 94574

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Florida Hospital Tampa

    Tampa, Florida, 33613

  • Baylor Scott and White Medical Center

    Temple, Texas, 76508

  • Toledo Clinic Cancer Centers

    Toledo, Ohio, 44614

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

    Topeka, Kansas, 66606

  • Arizona Oncology Associates, PC- HOPE - US Oncology Research

    Tucson, Arizona, 85711

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724-5024

  • Texas Oncology - Tyler - US Oncology Research

    Tyler, Texas, 75702

  • White Plains Hospital - Center for Cancer Care

    White Plains, New York, 10601

  • Novant Health Oncology Specialists

    Winston-Salem, North Carolina, 27103

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01605

Other trials in United States

China18 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • Peking Union Medical College Hospital

    Beijing

  • Peking University People'S Hospital

    Beijing

  • The first hospital of Jilin University

    Changchun, 130021

  • Sun Yat-sen Memorial Hospital Sun Yat-sen University

    Guangzhou, Guangdong, 510000

  • Guangdong provincial people's hospital

    Guangzhou, 510000

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150086

  • Jilin Guowen Hospital

    Jilin City, 136100

  • Linyi Cancer Hospital

    Linyi, Shandong, 276000

  • Shanghai Changhai Hospital

    Shanghai, 200433

  • Shanxi Provincial Cancer Hospital

    Shanxi, 030013

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

    Wuhan, Hubei, 430000

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

    Wuhan, Hubei, 430014

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • Xingtai People's Hospital

    Xingtai

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052

  • Henan Provincial Peoples Hospital

    Zhengzhou

Other trials in China

Mexico14 sites

  • Centro de Investigación Médica Aguascalientes (CIMA),

    Aguascalientes, 20116

  • Mediadvance Clinical

    Chihuahua City, Chih., 31210

  • Clinstile S.A. de C.V.,

    Cuauhtémoc, 06700

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

    Cuautitlán Izcalli, 54769

  • Hospitales Star Medica - Luna Parc

    Estado de México, 54750

  • Centro de Estudios de Alta Especialidad de Sinaloa, ubicado

    Mazatlán, Sinaloa, 82110

  • Accelerium S de RL de C.V.

    Monterrey, Nuevo León, 64000

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

    Monterrey, 64460

  • Oncocenter - Puebla

    Puebla City, 72530

  • Hospital Angeles San Luis

    San Luis Potosí City, 78200

  • Centro Potosino de Investigación Médica SC,

    San Luis Potosí City, 78250

  • Centro Hemato-Oncologico Privado CHOP

    Toluca, 50080

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

    Toluca, 50180

  • FAICIC Clinical Research

    Veracruz, 91900

Other trials in Mexico

South Korea13 sites

  • Keimyung University, Dongsan hospital

    Daegu, 42601

  • National Cancer Center

    Gyeonggi-do, 10408

  • Chonnam National University Hwasun Hospital

    Hwasun, 58128

  • Gachon University Gil Hospital

    Incheon, 21565

  • Inha University Hospital

    Incheon, 22332

  • Dong-A University Hospital

    Seogu, Busan, 602-715

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • CHA Bundang Medical Center, CHA University

    Seongnam-si

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Samsung Medical Center

    Seoul, 06351

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

    Seoul, 06591

  • Korea University Guro Hospital

    Seoul, 08308

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

Brazil12 sites

  • Centro de Pesquisa Clínica e Ensino Florianópolis LTDA

    Florianópolis, 88020

  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

    Ijuí, 98700

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90020-090

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, 90035

  • Hospital São Lucas da PUCRS

    Porto Alegre, 90610

  • IRPCc - Instituto Ribeirãopretano de Combate ao Câncer

    Ribeirão Preto, 14015-130

  • Oncoclinicas Group Botafogo

    Rio de Janeiro, 22250-040

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

    Rio de Janeiro, 22271

  • Groupo Clinicas Oncologicas Integradas (COI) - Barra da Tijuca

    Rio de Janeiro, 22775-001

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

    São Marcos, 41253-190

  • Núcleo de Pesquisa Clínica da Rede São Camilo

    São Paulo, 04014-002

  • Clínica OncoStar - REDE D´OR

    São Paulo, 04543

Other trials in Brazil

Spain9 sites

  • Instituto Oncòlogico Dr. Rosell

    Barcelona, 08028

  • Vall d´Hebron University Hospital

    Barcelona

  • Hospital General Universitario de Elche

    Elche

  • HM Hospitales - Centro Integral Oncologico Clara Campal - CIOCC

    Madrid, 28050

  • Hospital Universitario Ramon Y Cajal Carretera de Colmenar Viejo

    Madrid

  • Hospital Regional Universitario de Málaga

    Málaga, 29010

  • Clinica Universiatria de Navarra

    Pamplona, 31008

  • Hospital Universitario Marqués de Valdecilla

    Santander

  • Instituto Valenciano de Oncología IVO

    Valencia, 46009

Other trials in Spain

France8 sites

  • Centre Hospitalier de Bretagne Sud /Site du Scorff

    Lorient, 56322

  • Centre Léon Bérard

    Lyon

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

    Paris, 75012

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

    Pessac, Bordeaux, 33604

  • Hôpital Privé des Côtes d'Armor

    Plérin, 22190

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, 44805

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

    Strasbourg, 67000

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

    Strasbourg, 67000

Other trials in France

Germany7 sites

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116

  • Medizinische Hochschule Hannover, Klinik fur Gastroenterologie, Hepatologie und Endokrinologie

    Hanover

  • VK und K Studien GbR Landshut-Achdorf

    Landshut, 84036

  • Bonifatius Hospital Hematology and Oncology

    Lingen, 49808

  • Carl-von-Basedow-klinikum Saalekrei

    Merseburg, 06217

  • Klinikum München Bogenhausen, Klinik für Gastroenterologie und Gastroenterologische Onkologie

    München, 81925

  • Universitätsklinikum Ulm

    Ulm, D-89081

Other trials in Germany

Australia5 sites

  • Monash Medical Centre

    Clayton, VIC 3168

  • Greenslopes Private Hospital

    Greenslopes, Queensland, 4120

  • St. John of God Murdoch Hospital

    Murdoch, Western Australia, 6150

  • Sydney Adventist Hospital

    Wahroonga, NSW 2076

  • Westmead Hosptial

    Westmead, NSW 2145

Other trials in Australia

Czechia5 sites

  • Masaryk Institute of Oncology

    Brno-střed, 60200

  • Nemocnice Nový Jičín

    Nový Jičín, 741 01

  • University Hospital Olomouc

    Olomouc, 779 00

  • General University Hospital in Prague

    Prague, 128 08

  • Nemocnice Na Bulovce

    Prague, 180 81

Other trials in Czechia

Hungary5 sites

  • National Institute of Oncology

    Budapest, 1122

  • Bekes County Hospital

    Gyula, 5700

  • Bacs-Kiskun County Hospital

    Kecskemét, 6000

  • Tolna County Hospital

    Szekszárd, 7100

  • Jasz-Nagykun-Szolnok County Hospital

    Szolnok, 5000

Other trials in Hungary

Israel5 sites

  • Rambam Health Care Campus, Oncology Institute

    Haifa, 3109601

  • Hadassah Medical Center

    Jerusalem, 9112000

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Sheba Pancreatic Cancer Center - SPCC

    Ramat Gan

  • Sourasky Medical Center, Oncology Department

    Tel Aviv, 64239

Other trials in Israel

Italy5 sites

  • A.O. SS Antonio e Biagio e Cesare Arrigo

    Alessandria, 15121

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134

  • Università Campus Bio-Medico di Rome

    Roma, 00128

  • Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina

    Roma, 00186

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

    Torino, 10126

Other trials in Italy

Poland5 sites

  • Oncology Clinic Clinical Hospital of Przemienienia Pańskiego UM in Poznaniu

    Poznan, 60-596

  • Centrum Medyczne MrukMed

    Rzeszów, 35-021

  • Oncology and Radiotherapy Clinic, Oncology Center - Institute

    Warsaw, 02-034

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

    Warsaw, 02-507

  • Jan Mikulicz-Radecki University Teaching Hospital

    Wroclaw, 50-556

Other trials in Poland

Austria4 sites

  • Medical University Graz

    Graz, 17070

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, Wörthersee, 9020

  • Univ. Klinik für Innere Medizin III der PMU

    Salzburg, 5020

  • Landes-Krankenhaus Steyr

    Steyr, 4400

Other trials in Austria

Belgium3 sites

  • Faculté de Médecine Campus Erasme

    Anderlecht, 1070

  • UZ Leuven

    Leuven, 3000

  • Clinique Universutaire Saint Luc - Institut Roi Albert II

    Woluwe-Saint-Lambert, 1200

Other trials in Belgium

Canada3 sites

  • London Regional Cancer Program, London Health Sciences Centre

    London, Ontario, N6A 5W9

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

    Montreal, Quebec, H2X 3E4

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

    Sherbrooke, Quebec, J1G 1B1

Other trials in Canada

Switzerland2 sites

  • Hôpital Fribourgeois/Freiburger Spital

    Fribourg, 1708

  • KS Winterthur

    Winterthur, 8401

Other trials in Switzerland

Croatia1 site

  • University Hospital Centre Zagreb

    Zagreb, 10000

Other trials in Croatia

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

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

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.

Read the 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.

Being tested
NovoTTF-200T, Gemcitabine, nab paclitaxel
Keywords
Locally Advanced Pancreatic Adenocarcinoma, TTFields, Tumor Treating Fields, Gemcitabine, nab-Paclitaxel, Minimal toxicity, TTF, Novocure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NovoTTF-200TDevice

    Also called TTFields

    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.

  • GemcitabineDrug

    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 paclitaxelDrug

    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.

Study groups in NCT03377491
Study groupRoleWhat they receive
NovoTTF-200TExperimentalPatients receive TTFields using the NovoTTF-200T System together with gemcitabine and nab-Paclitaxel
Receives: Device: NovoTTF-200T; Drug: Gemcitabine; Drug: nab paclitaxel
Best Standard of CareActive comparatorPatients receive best standard of care with gemcitabine and nab-Paclitaxel
Receives: Drug: Gemcitabine; Drug: nab paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (8)

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

    Progression-free 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 the progression-free survival of subjects treated with chemotherapy alone, measured from the time of randomization and based on CT scans collected on the study, using the revised RECIST V1.1 Criteria.

    Progression is defined using the RECIST 1.1 criteria: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, in addition the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, progression was defined as unequivocal progression (an overall level of substantial worsening in non-target disease) of existing non-target lesions. The appearance of one or more new lesions is also considered progression.

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

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

    Local progression-free 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 the local progression-free survival of subjects treated with chemotherapy alone, measured from the time of randomization and based on CT scans collected on the study, using the revised RECIST V1.1 Criteria.

    Local progression is defined per RECIST 1.1 in the absence of distant metastasis: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, in addition the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, progression was defined as unequivocal progression (an overall level of substantial worsening) of existing non-target lesions. The appearance of one or more new lesions is also considered progression.

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

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

    Objective Response Rate (ORR) was assessed per RECIST v1.1. Complete Response (CR): disappearance of all target and non-target lesions and reduction of pathological lymph nodes to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions from baseline without new lesions or progression of non-target lesions. ORR is defined as the percentage of participants whose best overall response was CR or PR.

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

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

    One-year survival rate 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 the 1-year survival rate of subjects treated with chemotherapy alone.

    Measured: From randomization through 12 months after randomization.

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

    Quality of life deterioration-free survival (DFS) was assessed using the EORTC QLQ-C30 and pancreatic cancer-specific QLQ-PAN26 questionnaires. Higher scores on functional and global health status scales indicate better functioning, whereas higher symptom scores indicate worse symptoms.

    DFS was defined as the time from randomization to the first ≥10-point deterioration from baseline without a subsequent ≥10-point improvement, or death. DFS was evaluated separately for each QoL domain included in the analysis.

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

  6. Pain-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone

    Pain-free survival was measured as the duration between the time of randomization until a greater than or equal to twenty-point increase from baseline in a patient self-reported visual analogue scale (VAS) was recorded or death, whichever occurred first.

    Measured: From randomization until a ≥20-point increase from baseline in pain on the patient-reported visual analogue scale (0-100) or death, whichever occurs first.

  7. Puncture-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone

    Puncture-free 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 puncture-free survival of subjects treated with chemotherapy alone, measured as the duration between randomization until the first need for paracentesis or death, whichever occurs first.

    Measured: From randomization until the first paracentesis or death, whichever occurs first.

  8. Resectability Rate of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone

    Resectability rate defined as the number and percentage of patients whose tumors were deemed resectable and who underwent surgery.

    Measured: From randomization through the end of study follow-up. Surgical resections were captured throughout study follow-up, up to approximately 18 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2017
  2. Study start10 May 2018
  3. Primary completion16 Oct 2024
  4. Study completion16 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
571 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03377491
Sponsor's protocol ID
EF-27
Status last verified
Jan 2026
First submitted
6 Dec 2017
Last updated
21 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 15126372

  • 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.

    PubMed 17551011

  • 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.

    PubMed 22608262

  • 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.

    PubMed 19387848

  • 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.

    PubMed 26658786

  • 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.

    PubMed 26670971

  • 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.

    PubMed 24555979

  • 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.

    PubMed 29260225

  • Babiker HM, Picozzi V, Chandana SR, Melichar B, Kasi A, Gang J, Gallego J, Bullock A, Chunyi H, Wyrwicz L, Hitre E, Osipov A, de la Fouchardiere C, Ales I, Dragovich T, Lee W, Feeney K, Philip P, Ueno M, Van Cutsem E, Seufferlein T, Macarulla T; PANOVA-3 Study Investigators. Tumor Treating Fields With Gemcitabine and Nab-Paclitaxel for Locally Advanced Pancreatic Adenocarcinoma: Randomized, Open-Label, Pivotal Phase III PANOVA-3 Study. J Clin Oncol. 2025 Jul 20;43(21):2350-2360. doi: 10.1200/JCO-25-00746. Epub 2025 May 31.

    PubMed 40448572

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NovoTTF-200T, Gemcitabine and nab paclitaxel in people with Pancreas Adenocarcinoma, run by NovoCure Ltd. at 199 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 199 sites in United States, China, Mexico, South Korea, Brazil and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone (time frame: From randomization until death from any cause or last known alive.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03377491, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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