- ICH GCP
- US Clinical Trials Registry
- 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)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Patients receive gemcitabine and nab-paclitaxel in combination with TTFields using the NovoTTF-200T System.
- 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Clayton, Australia, VIC 3168
- Monash Medical Centre
-
Wahroonga, Australia, NSW 2076
- Sydney Adventist Hospital
-
Westmead, Australia, NSW 2145
- Westmead Hosptial
-
-
Queensland
-
Greenslopes, Queensland, Australia, 4120
- Greenslopes Private Hospital
-
-
Western Australia
-
Murdoch, Western Australia, Australia, 6150
- St. John of God Murdoch Hospital
-
-
-
-
-
Graz, Austria, 17070
- Medical University Graz
-
Salzburg, Austria, 5020
- Univ. Klinik für Innere Medizin III der PMU
-
Steyr, Austria, 4400
- Landes-Krankenhaus Steyr
-
-
Wörthersee
-
Klagenfurt, Wörthersee, Austria, 9020
- Klinikum Klagenfurt am Wörthersee
-
-
-
-
-
Anderlecht, Belgium, 1070
- Faculté de Médecine Campus Erasme
-
Leuven, Belgium, 3000
- UZ Leuven
-
Woluwe-Saint-Lambert, Belgium, 1200
- Clinique Universutaire Saint Luc - Institut Roi Albert II
-
-
-
-
-
Florianópolis, Brazil, 88020
- Centro de Pesquisa Clínica e Ensino Florianópolis LTDA
-
Ijuí, Brazil, 98700
- ONCOSITE - Centro de Pesquisa Clinica em Oncologia Ltda
-
Porto Alegre, Brazil, 90020-090
- Irmandade da Santa Casa de Misericórdia de Porto Alegre
-
Porto Alegre, Brazil, 90035
- Hospital de Clinicas de Porto Alegre
-
Porto Alegre, Brazil, 90610
- Hospital São Lucas da PUCRS
-
Ribeirão Preto, Brazil, 14015-130
- IRPCc - Instituto Ribeirãopretano de Combate ao Câncer
-
Rio De Janeiro, Brazil, 22250-040
- Oncoclinicas Group Botafogo
-
Rio De Janeiro, Brazil, 22271
- Instituto D'Or de Pesquisa e Ensino - Rio De Janeiro
-
Rio De Janeiro, Brazil, 22775-001
- Groupo Clinicas Oncologicas Integradas (COI) - Barra da Tijuca
-
São Marcos, Brazil, 41253-190
- Instituto D´Or de Pesquisa e Ensino - Hospital São Rafael
-
São Marcos, Brazil, 41253
- Hospital Sao Rafael
-
São Paulo, Brazil, 04014-002
- Nucleo de Pesquisa Clinica da Rede Sao Camilo
-
São Paulo, Brazil, 04543-000
- Onco Star Sp Oncologia Ltda
-
São Paulo, Brazil, 04543
- Clínica OncoStar - REDE D´OR
-
-
-
-
Ontario
-
London, Ontario, Canada, N6A 5W9
- London Regional Cancer Program, London Health Sciences Centre
-
-
Quebec
-
Montréal, Quebec, Canada, H2X 3E4
- Centre Hospitalier de I'Universitaire de de Montreal (CHUM)
-
Sherbrooke, Quebec, Canada, J1G 1B1
- Centre Hospitalier Universitaire de Sherbrooke CIUSSS de l'Estrie - CHUS
-
-
-
-
-
Beijing, China, 100142
- Beijing Cancer Hospital
-
Beijing, China
- Peking University People's Hospital
-
Changchun, China, 130021
- The First Hospital of Jilin University
-
Guangzhou, China, 510000
- Guangdong Provincial People's Hospital
-
Jilin, China, 136100
- Jilin Guowen Hospital
-
Shanghai, China, 200433
- Shanghai Changhai Hospital
-
Shanxi, China, 030013
- Shanxi Provincial Cancer Hospital
-
Xingtai, China
- Xingtai People's Hospital
-
Zhengzhou, China, 450052
- the First Affiliated Hospital of Zhengzhou University
-
Zhengzhou, China
- Henan Provincial Peoples Hospital
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- SUN YAT-SEN MEMORIAL HOSPITAL SUN YAT-SEN University
-
-
Heilongjiang
-
Harbin, Heilongjiang, China, 150086
- Harbin Medical University Cancer Hospital
-
-
Hubei
-
Wuhan, Hubei, China, 430000
- Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
-
Wuhan, Hubei, China, 430014
- Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710061
- The First Affiliated Hospital of Xi 'an Jiaotong University
-
-
Shandong
-
Linyi, Shandong, China, 276000
- Linyi Cancer Hospital
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
-
-
-
-
-
Zagreb, Croatia, 10000
- University Hospital Centre Zagreb
-
-
-
-
-
Brno Střed, Czechia, 60200
- Masaryk Institute of Oncology
-
Nový Jičín, Czechia, 741 01
- Nemocnice Nový Jičín
-
Olomouc, Czechia, 779 00
- University Hospital Olomouc
-
Praha 2, Czechia, 128 08
- General University Hospital in Prague
-
Praha 8, Czechia, 180 81
- Nemocnice Na Bulovce
-
-
-
-
-
Angers cedex, France, 49055
- Institut de Cancérologie de l'Ouest
-
Lorient, France, 56322
- Centre Hospitalier de Bretagne Sud /Site du Scorff
-
Lyon, France
- Centre Leon Berard
-
Paris, France, 75012
- Service d'Oncologie médicale du Pr. Andre, Hôpital Saint-Antoine
-
Plérin, France, 22190
- Hôpital Privé des Côtes d'Armor
-
Strasbourg, France, 67000
- Centre de Lutte Contre le Cancer (CLCC) - Centre Paul Strauss
-
Strasbourg, France, 67000
- Clinique Sainte Anne - Groupe Hospitalier Saint-Vincent, Strasbourg Oncologie Libérale
-
-
Bordeaux
-
Pessac, Bordeaux, France, 33604
- Hopital haut-Léveque CHU Bordeaux - Service d'Hépato- Gastroentérologie et d'Oncologie digestive
-
-
-
-
-
Chemnitz, Germany, 09116
- Klinikum Chemnitz gGmbH
-
Hannover, Germany
- Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie
-
Landshut, Germany, 84036
- VK und K Studien GbR Landshut-Achdorf
-
Lingen, Germany, 49808
- Bonifatius Hospital Hematology and Oncology
-
Merseburg, Germany, 06217
- Carl-von-Basedow-klinikum Saalekrei
-
München, Germany, 81925
- Klinikum München Bogenhausen, Klinik für Gastroenterologie und Gastroenterologische Onkologie
-
Ulm, Germany, D-89081
- Universitätsklinikum Ulm
-
-
-
-
-
Hong Kong, Hong Kong
- Queen Mary Hospital
-
-
-
-
-
Budapest, Hungary, 1122
- National Institute of Oncology
-
Gyula, Hungary, 5700
- Békés county hospital
-
Kecskemét, Hungary, 6000
- Bács-Kiskun County Hospital
-
Szekszárd, Hungary, 7100
- Tolna County Hospital
-
Szolnok, Hungary, 5000
- Jasz-Nagykun-Szolnok County Hospital
-
-
-
-
-
Haifa, Israel, 3109601
- Rambam Health Care Campus, Oncology Institute
-
Petah tikva, Israel, 4941492
- Rabin Medical Center
-
Ramat Gan, Israel, 5268102
- Hadassah Medical Center
-
Ramat Gan, Israel
- Sheba Pancreatic Cancer Center - SPCC
-
Tel Aviv, Israel, 64239
- Sourasky Medical Center, Oncology Department
-
-
-
-
-
Alessandria, Italy, 15121
- A.O. SS Antonio e Biagio e Cesare Arrigo
-
Firenze, Italy, 50134
- Azienda Ospedaliero-Universitaria Careggi
-
Roma, Italy, 00128
- Università Campus Bio-Medico di Rome
-
Roma, Italy, 00186
- Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina
-
Torino, Italy, 10126
- A.O.U Città della Salute e della Scienza di Torino
-
-
-
-
-
Daegu, Korea, Republic of, 42601
- Keimyung University, Dongsan Hospital
-
Gyeonggi-do, Korea, Republic of, 10408
- National Cancer Center
-
Hwasun, Korea, Republic of, 58128
- Chonnam National University Hwasun Hospital
-
Incheon, Korea, Republic of, 22332
- Inha University Hospital
-
Incheon, Korea, Republic of, 21565
- Gachon University Gil Hospital
-
Seongnam-si, Korea, Republic of
- CHA Bundang Medical Center, CHA University
-
Seoul, Korea, Republic of, 03722
- Severance Hospital, Yonsei University Health System
-
Seoul, Korea, Republic of, 06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Seoul, Korea, Republic of, 08308
- Korea University Guro Hospital
-
Seoul, Korea, Republic of, 06351
- Samsung Medical Center
-
Suwon, Korea, Republic of, 16499
- Ajou University Hospital
-
-
Busan
-
Seogu, Busan, Korea, Republic of, 602-715
- Dong-A University Hospital
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
- Seoul National University Bundang Hospital
-
-
-
-
-
Aguascalientes, Mexico, 20116
- Centro de Investigación Médica Aguascalientes (CIMA),
-
Cuauhtémoc, Mexico, 06700
- Clinstile S.A. de C.V.,
-
Cuautitlán Izcalli, Mexico, 54769
- Phylasis Clinicas Research S. de R.L. de C.V.
-
Estado De México, Mexico, 54750
- Hospitales Star Medica - Luna Parc
-
Monterrey, Mexico, 64460
- Universidad Autonoma de Nuevo Leon - Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
-
Puebla, Mexico, 72530
- Oncocenter - Puebla
-
San Luis Potosí, Mexico, 78200
- Hospital Angeles San Luis
-
San Luis Potosí, Mexico, 78250
- Centro Potosino de Investigación Médica SC,
-
Toluca De Lerdo, Mexico, 50180
- Phylasis Clinicas Research S.de R.L. de C.V. (PCR)-Toluca
-
Toluca de Lerdo, Mexico, 50080
- Centro Hemato-Oncologico Privado CHOP
-
Veracruz, Mexico, 91900
- FAICIC Clínical Research
-
-
Chih.
-
Chihuahua, Chih., Mexico, 31210
- Mediadvance Clinical
-
-
NL
-
Monterrey, NL, Mexico, 64000
- Accelerium S de RL de C.V.
-
-
Sinaloa
-
Mazatlán, Sinaloa, Mexico, 82110
- Centro de Estudios de Alta Especialidad de Sinaloa, ubicado
-
-
-
-
-
Poznań, Poland, 60-596
- Oncology Clinic Clinical Hospital of Przemienienia Pańskiego UM in Poznaniu
-
Rzeszów, Poland, 35-021
- Centrum Medyczne MrukMed
-
Warsaw, Poland, 02-034
- Oncology and Radiotherapy Clinic, Oncology Center - Institute
-
Warsaw, Poland, 02-507
- Oncology and Radiotherapy Clinic University Clinical Center Non-Invasive Medicine Center
-
Wrocław, Poland, 50-556
- Jan Mikulicz-Radecki University Teaching Hospital
-
-
-
-
-
Barcelona, Spain, 08028
- Instituto Oncológico Dr. Rosell
-
Barcelona, Spain
- Vall d´Hebrón University Hospital
-
Elche, Spain
- Hospital General Universitario de Elche
-
Madrid, Spain, 28050
- HM Hospitales - Centro Integral Oncologico Clara Campal - CIOCC
-
Málaga, Spain, 29010
- Hospital Regional Universitario de Malaga
-
Pamplona, Spain, 31008
- Clinica Universiatria de Navarra
-
Santander, Spain
- Hospital Universitario Marques de Valdecilla
-
Valencia, Spain, 46009
- Instituto Valenciano de Oncologia IVO
-
-
-
-
-
Fribourg, Switzerland, 1708
- Hôpital Fribourgeois/Freiburger Spital
-
Winterthur, Switzerland, 8401
- KS Winterthur
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35243
- Grandview Medical Center, Cancer Center
-
Mobile, Alabama, United States, 36607
- Infirmary Cancer Care
-
-
Arizona
-
Gilbert, Arizona, United States, 85234
- Banner MD Anderson Cancer Center
-
Tucson, Arizona, United States, 85724-5024
- University of Arizona Cancer Center
-
Tucson, Arizona, United States, 85711
- Arizona Oncology Associates, PC- HOPE - US Oncology Research
-
-
California
-
Anaheim, California, United States, 92801
- Pacific Cancer Medical Center
-
Fullerton, California, United States, 92835
- St. Joseph Heritage Healthcare - Virginia K. Crosson Cancer Center
-
Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
-
Sacramento, California, United States, 95816
- Dignity Health - Mercy Cancer Centers
-
Sacramento, California, United States, 95816
- Sutter Cancer Center Sacramento
-
Saint Helena, California, United States, 94574
- Adventist Health St. Helena - Martin-O'Neil Cancer Center (MOCC)
-
Santa Barbara, California, United States, 93105
- Ridley-Tree Cancer Center
-
-
Connecticut
-
Milford, Connecticut, United States, 06460
- Associated Neurologists of Southern Connecticut, P.C.
-
-
Florida
-
Boca Raton, Florida, United States, 33486
- Boca Raton Regional Hospital, Lynn Cancer Institute
-
Fort Myers, Florida, United States, 33905
- Florida Cancer Specialists & Research Institute - Colonial Office
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic Hospital - Florida
-
Miami Beach, Florida, United States, 33140
- Mount Sinai Medical Center
-
Orlando, Florida, United States, 32804
- AdventHealth Neuro Oncology
-
Plantation, Florida, United States, 33324
- BRCR Medical Center Inc
-
Saint Petersburg, Florida, United States, 33705
- Florida Cancer Specialists
-
Tampa, Florida, United States, 33613
- Florida Hospital Tampa
-
-
Georgia
-
Atlanta, Georgia, United States, 30318
- Piedmont Cancer Institute
-
-
Illinois
-
Arlington Heights, Illinois, United States, 60005
- Illinois Cancer Specialist - US Oncology Research
-
Chicago, Illinois, United States, 60612
- Rush University Medical Center
-
Evanston, Illinois, United States, 60201
- NorthShore University HealthSystem
-
Maywood, Illinois, United States, 60153
- Loyola University Medical Center
-
-
Kansas
-
Fairway, Kansas, United States, 66205
- University of Kansas Medical Cancer Center
-
Topeka, Kansas, United States, 66606
- Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center)
-
-
Kentucky
-
Edgewood, Kentucky, United States, 41017
- Saint Elizabeth Healthcare
-
Louisville, Kentucky, United States, 40202
- Norton Cancer Institute, Norton Healthcare Pavilion
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70121
- Ochsner Medical Center
-
-
Maine
-
Lewiston, Maine, United States, 04240
- Central Maine Medical Center, Clinical Research Department
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland Comprehensive Cancer Center
-
Columbia, Maryland, United States, 21044
- Maryland Oncology Hematology, P.A - US Oncology Research
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
Worcester, Massachusetts, United States, 01605
- UMass Memorial Medical Center
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Karmanos Cancer Institute
-
Grand Rapids, Michigan, United States, 49503
- Cancer and Hematology Centers of Western Michigan, PC
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
-
Missouri
-
Kansas City, Missouri, United States, 64132
- MidAmerica Division
-
-
Nebraska
-
Omaha, Nebraska, United States, 68114
- Nebraska Methodist Hospital
-
-
Nevada
-
Las Vegas, Nevada, United States, 89102
- OptumCare Cancer Care
-
Las Vegas, Nevada, United States, 89619
- Comprehensive Cancer Centers of Nevada
-
Reno, Nevada, United States, 89502
- Renown Institute for Heart & Vascular Health
-
-
New Jersey
-
East Brunswick, New Jersey, United States, 08816
- Astera Cancer Care
-
-
New York
-
Buffalo, New York, United States, 14210
- Kaleida Health
-
Cooperstown, New York, United States, 13326
- Bassett Medical Center
-
Flushing, New York, United States, 11355
- New York Hospital Queens
-
Lake Success, New York, United States, 11042
- NYU Langone Arena Oncology
-
White Plains, New York, United States, 10601
- White Plains Hospital - Center for Cancer Care
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27103
- Novant Health Oncology Specialists
-
-
Ohio
-
Canton, Ohio, United States, 44718
- Gabrail Cancer Research Center
-
Toledo, Ohio, United States, 44614
- Toledo Clinic Cancer Centers
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
-
-
Oregon
-
Eugene, Oregon, United States, 97401
- Willamette Valley Cancer Institute and Research Center - US Oncology Research
-
-
Pennsylvania
-
Danville, Pennsylvania, United States, 17822
- Geisinger Medical Center
-
Fountain Hill, Pennsylvania, United States, 18015
- Vita Medical Associates, P.C.
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37403
- UT/Erlanger Oncology & Hematology
-
Knoxville, Tennessee, United States, 37909-1327
- Tennessee Cancer Specialists
-
Nashville, Tennessee, United States, 37203
- Tennessee Oncology
-
-
Texas
-
Beaumont, Texas, United States, 77702
- Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center - US Oncology Research
-
Bedford, Texas, United States, 76022
- Texas Oncology - Bedford - US Oncology Reasearch
-
Dallas, Texas, United States, 75203
- Methodist Regional Cancer Center
-
Dallas, Texas, United States, 75246
- Texas Oncology - Baylor - US Oncology Research
-
El Paso, Texas, United States, 79915
- Texas Oncology - El Paso Cancer Treatment Center Gateway - US Oncology Research
-
Houston, Texas, United States, 77030
- Houston Methodist Cancer Center
-
Temple, Texas, United States, 76508
- Baylor Scott and White Medical Center
-
Tyler, Texas, United States, 75702
- Texas Oncology - Tyler - US Oncology Research
-
-
Virginia
-
Roanoke, Virginia, United States, 24014
- Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - US Oncology Research
-
-
Washington
-
Olympia, Washington, United States, 98506
- Vista Oncology Inc PS
-
Seattle, Washington, United States, 98109
- Seattle Cancer Care Alliance
-
Seattle, Washington, United States, 98101
- Virginia Mason Medical Center
-
-
West Virginia
-
Morgantown, West Virginia, United States, 26506
- West Virginia University Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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°
- 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
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Best Standard of Care
Patients receive best standard of care with gemcitabine and nab-Paclitaxel
|
Gemcitabine 1000 mg/m^2 over 30 minute infusion will be administered immediately after nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle.
nab-paclitaxel 125 mg/m^2 administered as an intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle.
|
Experimental: NovoTTF-200T
Patients receive TTFields using the NovoTTF-200T System together with gemcitabine and nab-Paclitaxel
|
Gemcitabine 1000 mg/m^2 over 30 minute infusion will be administered immediately after nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle.
nab-paclitaxel 125 mg/m^2 administered as an intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle.
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 4 years
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: 4 years
|
4 years
|
|
Local progression-free survival
Time Frame: 4 years
|
4 years
|
|
Objective response rate
Time Frame: 4 years
|
4 years
|
|
One-year survival rate
Time Frame: 4 years
|
4 years
|
|
Quality of life
Time Frame: 4 years
|
Quality of life will be assessed using the EORTC QLQ C-30 questionnaire with EORTC QLQ-PAN26 (Pancreatic Cancer symptom) supplement.
|
4 years
|
Pain-free survival
Time Frame: 4 years
|
Pain-free survival will measured as the duration between the time of randomization until a greater than or equal to two-point decline from a baseline measurement in a patient self-reported visual analogue scale (VAS) is recorded or death, whichever occurs first.
|
4 years
|
Puncture-free survival
Time Frame: 4 years
|
4 years
|
|
Resectability rate
Time Frame: 4 years
|
4 years
|
|
Toxicity profile
Time Frame: 4 years
|
Toxicity profile in patients treated with TTFields in combination with gemcitabine and nab-paclitaxel compared to the toxicity profile of patients treated with chemotherapy alone, measured by the rate of treatment-emergent toxicities in both arms.
Adverse events will be collected and recorded based on the revised Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
|
4 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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. Erratum In: JAMA. 2018 May 1;319(17):1824.
- Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.
- Kirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Gemcitabine
- Paclitaxel
Other Study ID Numbers
- EF-27
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pancreas Adenocarcinoma
-
The Cooper Health SystemTerminatedPancreatic Cancer | Pancreatic Adenocarcinoma | Pancreas Adenocarcinoma | Pancreas Cancer | Adenocarcinoma of the PancreasUnited States
-
The Cooper Health SystemUnknownPancreatic Cancer | Pancreatic Adenocarcinoma | Pancreas Adenocarcinoma | Pancreas Cancer | Adenocarcinoma of the PancreasUnited States
-
Samyang Biopharmaceuticals CorporationUnknownMetastatic Adenocarcinoma of the Pancreas | Recurrent Adenocarcinoma of the PancreasKorea, Republic of
-
Washington University School of MedicineCompletedAdenocarcinoma PancreasUnited States
-
Prof. Dr. med. Dres. h.c. Jan Schmidt, MMERecruitingPancreatic Neoplasms | Pancreatic Cancer | Pancreatic Adenocarcinoma | Pancreas Adenocarcinoma | Pancreas Cancer | Pancreas NeoplasmSwitzerland
-
Umeå UniversityKarolinska University Hospital; Sahlgrenska University Hospital, Sweden; University... and other collaboratorsRecruitingQuality of Life | Surgery | Pancreas Adenocarcinoma | Chemotherapy Effect | Pancreas Cancer | Pancreas Neoplasm | Pancreas Disease | Locally Advanced Pancreatic Adenocarcinoma | Borderline Resectable Pancreatic AdenocarcinomaSweden
-
Medical College of WisconsinBarbara Ann Karmanos Cancer Institute; Cornerstone PharmaceuticalsRecruitingPancreas AdenocarcinomaUnited States
-
Capital Health System, IncRecruitingPancreas AdenocarcinomaUnited States
-
Centre Leon BerardActive, not recruitingPancreas AdenocarcinomaFrance
-
Mayo ClinicWithdrawnPancreas Adenocarcinoma
Clinical Trials on Gemcitabine
-
AstraZenecaRecruitingBiliary Tract CancerFrance, Spain, Italy, Korea, Republic of, Japan, Germany, United States, Singapore
-
Sierra Oncology LLC - a GSK companyCompletedAdvanced Solid TumorsSpain, United Kingdom
-
Shenzhen University General HospitalNot yet recruiting
-
University of Erlangen-Nürnberg Medical SchoolCompleted
-
3D Medicines (Sichuan) Co., Ltd.Not yet recruitingBiliary Tract Neoplasms
-
Fifth Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
-
3D Medicines (Sichuan) Co., Ltd.RecruitingBiliary Tract NeoplasmsChina
-
Kansai Hepatobiliary Oncology GroupCompleted
-
Air Force Military Medical University, ChinaRecruiting
-
SUNHO(China)BioPharmaceutical CO., Ltd.Recruiting