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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)

Primary Purpose

Pancreas Adenocarcinoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NovoTTF-200T
Gemcitabine
nab paclitaxel
Sponsored by
NovoCure Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Adenocarcinoma focused on measuring Locally Advanced Pancreatic Adenocarcinoma, TTFields, Tumor Treating Fields, Gemcitabine, nab-Paclitaxel, Minimal toxicity, TTF, Novocure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years of age and older
  2. Life expectancy of ≥ 3 months
  3. Histological/cytological diagnosis of de novo adenocarcinoma of the pancreas

  4. Unresectable, locally advanced stage disease according to the following criteria:

    • Head/uncinate process:

      1. Solid tumor contact with SMA>180°
      2. Solid tumor contact with the CA>180°
      3. Solid tumor contact with the first jejunal SMA branch
      4. Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t tumor or bland thrombus)
      5. Contact with most proximal draining jejunal branch into SMV

    • Body and tail

      1. Solid tumor contact of >180° with the SMA or CA
      2. Solid tumor contact with the CA and aortic involvement
      3. Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t tumor or bland thrombus)
    • No distant metastasis, including non-regional lymph node metastasis
    • No borderline resectable (per Al-Hawary MM, et al., Radiology 201414)
  5. ECOG score 0-2
  6. Amenable and assigned by the investigator to receive therapy with gemcitabine and nab-paclitaxel
  7. Able to operate the NovoTTF-100L(P) System independently or with the help of a caregiver
  8. Signed informed consent form for the study protocol

Exclusion Criteria:

  1. Prior palliative treatment (e.g. surgery, radiation) to the tumor
  2. Cancer requiring anti-tumor treatment within the 5 years before inclusion, excluding treated stage I prostate cancer, in situ cervical or uterus cancer, in situ breast cancer and non-melanomatous skin cancer.

  3. Serious co-morbidities:

    1. Clinically significant (as determined by the investigator) hematological, hepatic and renal dysfunction, defined as: Neutrophil count < 1.5 x 10^9/L and platelet count < 100 x 10^9/L; bilirubin > 1.5 x Upper Limit of Normal (ULN); AST and/or ALT > 2.5 x ULN; and serum creatinine > 1.5 x ULN.
    2. History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea).
    3. History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial.
    4. History of cerebrovascular accident (CVA) within 6 months prior to randomization or that is not stable.
    5. Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol therapy.
    6. History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent.
  4. Concurrent anti-tumor therapy beyond gemcitabine and nab-paclitaxel
  5. Implantable electronic medical devices in the torso, such as pacemakers
  6. Known severe hypersensitivities to medical adhesives or hydrogel, or to one of the chemotherapies used in this trial.
  7. Pregnancy or breast-feeding (female patients with reproductive potential and their partners must accept to use effective contraception throughout the entire study period and for 3 months after the end of treatment). All patients who are capable of becoming pregnant must take a pregnancy test which is negative within 72 hours before beginning treatment. The definition of effective contraception is left up to the decision of the investigator.
  8. Unable to follow the protocol for medical, psychological, familial, geographic or other reasons.
  9. Admitted to an institution by administrative or court order.

Sites / Locations

  • Grandview Medical Center, Cancer Center
  • Infirmary Cancer Care
  • Banner MD Anderson Cancer Center
  • Arizona Oncology Associates, PC- HOPE - US Oncology Research
  • University of Arizona Cancer Center
  • Pacific Cancer Medical Center
  • St. Joseph Heritage Healthcare - Virginia K. Crosson Cancer Center
  • Cedars-Sinai Medical Center
  • Dignity Health - Mercy Cancer Centers
  • Sutter Cancer Center Sacramento
  • Adventist Health St. Helena - Martin-O'Neil Cancer Center (MOCC)
  • Ridley-Tree Cancer Center
  • Associated Neurologists of Southern Connecticut, P.C.
  • Boca Raton Regional Hospital, Lynn Cancer Institute
  • Florida Cancer Specialists & Research Institute - Colonial Office
  • Mayo Clinic Hospital - Florida
  • Mount Sinai Medical Center
  • AdventHealth Neuro Oncology
  • BRCR Medical Center INC
  • Florida Cancer Specialists
  • Florida Hospital Tampa
  • Piedmont Cancer Institute
  • Illinois Cancer Specialist - US Oncology Research
  • Rush University Medical Center
  • NorthShore University HealthSystem
  • Loyola University Medical Center
  • University of Kansas Medical Cancer Center
  • Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center)
  • Saint Elizabeth Healthcare
  • Norton Cancer Institute, Norton Healthcare Pavilion
  • Ochsner Medical Center
  • Central Maine Medical Center, Clinical Research Department
  • University of Maryland Comprehensive Cancer Center
  • Maryland Oncology Hematology, P.A - US Oncology Research
  • Beth Israel Deaconess Medical Center
  • UMass Memorial Medical Center
  • Karmanos Cancer Institute
  • Cancer and Hematology Centers of Western Michigan, PC
  • University of Minnesota
  • MidAmerica Division
  • Nebraska Methodist Hospital
  • OptumCare Cancer Care
  • Comprehensive Cancer Centers of Nevada
  • Renown Institute for Heart & Vascular Health
  • Astera Cancer Care
  • Kaleida Health
  • Bassett Medical Center
  • New York Hospital Queens
  • NYU Langone Arena Oncology
  • White Plains Hospital - Center for Cancer Care
  • Novant Health Oncology Specialists
  • Gabrail Cancer Research Center
  • Toledo Clinic Cancer Centers
  • University of Oklahoma Health Sciences Center
  • Willamette Valley Cancer Institute and Research Center - US Oncology Research
  • Geisinger Medical Center
  • Vita Medical Associates, P.C.
  • UT/Erlanger Oncology & Hematology
  • Tennessee Cancer Specialists
  • Tennessee Oncology
  • Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center - US Oncology Research
  • Texas Oncology - Bedford - US Oncology Reasearch
  • Methodist Regional Cancer Center
  • Texas Oncology - Baylor - US Oncology Research
  • Texas Oncology - El Paso Cancer Treatment Center Gateway - US Oncology Research
  • Houston Methodist Cancer Center
  • Baylor Scott and White Medical Center
  • Texas Oncology - Tyler - US Oncology Research
  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - US Oncology Research
  • Vista Oncology Inc PS
  • Virginia Mason Medical Center
  • Seattle Cancer Care Alliance
  • West Virginia University Cancer Institute
  • Greenslopes Private Hospital
  • St. John of God Murdoch Hospital
  • Monash Medical Centre
  • Sydney Adventist Hospital
  • Westmead Hosptial
  • Klinikum Klagenfurt am Wörthersee
  • Medical University Graz
  • Univ. Klinik für Innere Medizin III der PMU
  • Landes-Krankenhaus Steyr
  • Faculté de Médecine Campus Erasme
  • UZ Leuven
  • Clinique Universutaire Saint Luc - Institut Roi Albert II
  • Centro de Pesquisa Clínica e Ensino Florianópolis LTDA
  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre
  • Hospital de Clínicas de Porto Alegre
  • Hospital São Lucas da PUCRS
  • IRPCc - Instituto Ribeirãopretano de Combate ao Câncer
  • Oncoclinicas Group Botafogo
  • Instituto D'Or de Pesquisa e Ensino - Rio De Janeiro
  • Groupo Clinicas Oncologicas Integradas (COI) - Barra da Tijuca
  • Instituto D´Or de Pesquisa e Ensino - Hospital São Rafael
  • Hospital São Rafael
  • Núcleo de Pesquisa Clínica da Rede São Camilo
  • Onco Star SP Oncologia LTDA
  • Clínica OncoStar - REDE D´OR
  • London Regional Cancer Program, London Health Sciences Centre
  • Centre Hospitalier de I'Universitaire de de Montreal (CHUM)
  • Centre Hospitalier Universitaire de Sherbrooke CIUSSS de l'Estrie - CHUS
  • Sun Yat-sen Memorial Hospital Sun Yat-sen University
  • Harbin Medical University Cancer Hospital
  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
  • The First Affiliated Hospital of Xi 'an Jiaotong University
  • Linyi Cancer Hospital
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  • Beijing Cancer Hospital
  • Peking University People'S Hospital
  • The first hospital of Jilin University
  • Guangdong provincial people's hospital
  • Jilin Guowen Hospital
  • Shanghai Changhai Hospital
  • Shanxi Provincial Cancer Hospital
  • Xingtai People's Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Henan Provincial Peoples Hospital
  • University Hospital Centre Zagreb
  • Masaryk Institute of Oncology
  • Nemocnice Nový Jičín
  • University Hospital Olomouc
  • General University Hospital in Prague
  • Nemocnice Na Bulovce
  • Hopital haut-Léveque CHU Bordeaux - Service d'Hépato- Gastroentérologie et d'Oncologie digestive
  • Institut de Cancérologie de l'Ouest
  • Centre Hospitalier de Bretagne Sud /Site du Scorff
  • Centre Léon Bérard
  • Service d'Oncologie médicale du Pr. Andre, Hôpital Saint-Antoine
  • Hôpital Privé des Côtes d'Armor
  • Centre de Lutte Contre le Cancer (CLCC) - Centre Paul Strauss
  • Clinique Sainte Anne - Groupe Hospitalier Saint-Vincent, Strasbourg Oncologie Libérale
  • Klinikum Chemnitz gGmbH
  • Medizinische Hochschule Hannover, Klinik fur Gastroenterologie, Hepatologie und Endokrinologie
  • VK und K Studien GbR Landshut-Achdorf
  • Bonifatius Hospital Hematology and Oncology
  • Carl-von-Basedow-klinikum Saalekrei
  • Klinikum München Bogenhausen, Klinik für Gastroenterologie und Gastroenterologische Onkologie
  • Universitätsklinikum Ulm
  • Queen Mary Hospital
  • National Institute of Oncology
  • Bekes County Hospital
  • Bacs-Kiskun County Hospital
  • Tolna County Hospital
  • Jasz-Nagykun-Szolnok County Hospital
  • Rambam Health Care Campus, Oncology Institute
  • Rabin Medical Center
  • Hadassah Medical Center
  • Sheba Pancreatic Cancer Center - SPCC
  • Sourasky Medical Center, Oncology Department
  • A.O. SS Antonio e Biagio e Cesare Arrigo
  • Azienda Ospedaliero-Universitaria Careggi
  • Università Campus Bio-Medico di Rome
  • Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina
  • A.O.U Città della Salute e della Scienza di Torino
  • Dong-A University Hospital
  • Seoul National University Bundang Hospital
  • Keimyung University, Dongsan hospital
  • National Cancer Center
  • Chonnam National University Hwasun Hospital
  • Gachon University Gil Hospital
  • Inha University Hospital
  • CHA Bundang Medical Center, CHA University
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Korea University Guro Hospital
  • Ajou University Hospital
  • Mediadvance Clinical
  • Accelerium S de RL de C.V.
  • Centro de Estudios de Alta Especialidad de Sinaloa, ubicado
  • Centro de Investigación Médica Aguascalientes (CIMA),
  • Clinstile S.A. de C.V.,
  • Phylasis Clinicas Research S. de R.L. de C.V.
  • Hospitales Star Medica - Luna Parc
  • Universidad Autonoma de Nuevo Leon - Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Oncocenter - Puebla
  • Hospital Angeles San Luis
  • Centro Potosino de Investigación Médica SC,
  • Centro Hemato-Oncologico Privado CHOP
  • Phylasis Clinicas Research S.de R.L. de C.V. (PCR)-Toluca
  • FAICIC Clinical Research
  • Oncology Clinic Clinical Hospital of Przemienienia Pańskiego UM in Poznaniu
  • Centrum Medyczne MrukMed
  • Oncology and Radiotherapy Clinic, Oncology Center - Institute
  • Oncology and Radiotherapy Clinic University Clinical Center Non-Invasive Medicine Center
  • Jan Mikulicz-Radecki University Teaching Hospital
  • Instituto Oncòlogico Dr. Rosell
  • Vall d´Hebron University Hospital
  • Hospital General Universitario de Elche
  • HM Hospitales - Centro Integral Oncologico Clara Campal - CIOCC
  • Hospital Regional Universitario de Málaga
  • Clinica Universiatria de Navarra
  • Hospital Universitario Marqués de Valdecilla
  • Instituto Valenciano de Oncología IVO
  • Hôpital Fribourgeois/Freiburger Spital
  • KS Winterthur

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NovoTTF-200T

Best Standard of Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Progression-free survival
Local progression-free survival
Objective response rate
One-year survival rate
Quality of life
Quality of life will be assessed using the EORTC QLQ C-30 questionnaire with EORTC QLQ-PAN26 (Pancreatic Cancer symptom) supplement.
Pain-free survival
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.
Puncture-free survival
Resectability rate
Toxicity profile
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.

Full Information

First Posted
December 6, 2017
Last Updated
April 7, 2023
Sponsor
NovoCure Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03377491
Brief Title
Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3)
Official Title
Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Gemcitabine and Nab-paclitaxel for Front-line Treatment of Locally-advanced Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 10, 2018 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NovoCure Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Brief Summary: The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic adenocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
Detailed Description
PAST PRE-CLINICAL AND CLINICAL EXPERIENCE: The effect of the electric fields (TTFields, TTF) has demonstrated significant activity in in vitro and in vivo pancreatic adenocarcinoma pre-clinical models both as a single modality treatment and in combination with chemotherapies. TTFields have been demonstrated to act synergistically with taxanes and have been shown to be additive when combined with other chemotherapies including gemcitabine. In addition, TTFields have shown to inhibit metastatic spread of malignant melanoma in in vivo experiment. In a pilot study, 40 patients with locally advanced or metastatic pancreatic adenocarcinoma received gemcitabine together with TTFields (150 kHz) or gemcitabine and nab-paclitaxel together with TTFields (150 kHz) applied to the abdomen until disease progression. The combination was well tolerated and the only device-related adverse event was contact dermatitis. In addition, a phase III trial of Optune® (200 kHz) as monotherapy compared to active chemotherapy in recurrent glioblastoma patients showed TTFields to be equivalent to active chemotherapy in extending survival, associated with minimal toxicity, good quality of life, and activity within the brain (14% response rate) (Stupp R., et al., EJC 2012). Finally, a phase III trial of Optune® combined with maintenance temozolomide compared to maintenance temozolomide alone has shown that combined therapy led to a significant improvement in both progression free survival and overall survival in patients with newly diagnosed glioblastoma without the addition of high grade toxicity and without decline in quality of life (Stupp R., et al., JAMA 2017). DESCRIPTION OF THE TRIAL: All patients included in this trial are patients with locally advanced pancreatic adenocarcinoma. In addition, all patients must meet all eligibility criteria. Eligible patients will be randomly assigned to one of two groups: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Adenocarcinoma
Keywords
Locally Advanced Pancreatic Adenocarcinoma, TTFields, Tumor Treating Fields, Gemcitabine, nab-Paclitaxel, Minimal toxicity, TTF, Novocure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
556 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NovoTTF-200T
Arm Type
Experimental
Arm Description
Patients receive TTFields using the NovoTTF-200T System together with gemcitabine and nab-Paclitaxel
Arm Title
Best Standard of Care
Arm Type
Active Comparator
Arm Description
Patients receive best standard of care with gemcitabine and nab-Paclitaxel
Intervention Type
Device
Intervention Name(s)
NovoTTF-200T
Other Intervention Name(s)
TTFields
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
nab paclitaxel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
4 years
Title
Local progression-free survival
Time Frame
4 years
Title
Objective response rate
Time Frame
4 years
Title
One-year survival rate
Time Frame
4 years
Title
Quality of life
Description
Quality of life will be assessed using the EORTC QLQ C-30 questionnaire with EORTC QLQ-PAN26 (Pancreatic Cancer symptom) supplement.
Time Frame
4 years
Title
Pain-free survival
Description
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.
Time Frame
4 years
Title
Puncture-free survival
Time Frame
4 years
Title
Resectability rate
Time Frame
4 years
Title
Toxicity profile
Description
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.
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Grandview Medical Center, Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Infirmary Cancer Care
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36607
Country
United States
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Arizona Oncology Associates, PC- HOPE - US Oncology Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States
Facility Name
Pacific Cancer Medical Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
St. Joseph Heritage Healthcare - Virginia K. Crosson Cancer Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Dignity Health - Mercy Cancer Centers
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Sutter Cancer Center Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Adventist Health St. Helena - Martin-O'Neil Cancer Center (MOCC)
City
Saint Helena
State/Province
California
ZIP/Postal Code
94574
Country
United States
Facility Name
Ridley-Tree Cancer Center
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Associated Neurologists of Southern Connecticut, P.C.
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Boca Raton Regional Hospital, Lynn Cancer Institute
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute - Colonial Office
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33905
Country
United States
Facility Name
Mayo Clinic Hospital - Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
AdventHealth Neuro Oncology
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
BRCR Medical Center INC
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Florida Cancer Specialists
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Florida Hospital Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Piedmont Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Illinois Cancer Specialist - US Oncology Research
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Kansas Medical Cancer Center
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center)
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Saint Elizabeth Healthcare
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Norton Cancer Institute, Norton Healthcare Pavilion
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Central Maine Medical Center, Clinical Research Department
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
University of Maryland Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Maryland Oncology Hematology, P.A - US Oncology Research
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Cancer and Hematology Centers of Western Michigan, PC
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
MidAmerica Division
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
OptumCare Cancer Care
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89619
Country
United States
Facility Name
Renown Institute for Heart & Vascular Health
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Astera Cancer Care
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Facility Name
Kaleida Health
City
Buffalo
State/Province
New York
ZIP/Postal Code
14210
Country
United States
Facility Name
Bassett Medical Center
City
Cooperstown
State/Province
New York
ZIP/Postal Code
13326
Country
United States
Facility Name
New York Hospital Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
NYU Langone Arena Oncology
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
White Plains Hospital - Center for Cancer Care
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Facility Name
Novant Health Oncology Specialists
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Gabrail Cancer Research Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Toledo Clinic Cancer Centers
City
Toledo
State/Province
Ohio
ZIP/Postal Code
44614
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Willamette Valley Cancer Institute and Research Center - US Oncology Research
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Vita Medical Associates, P.C.
City
Fountain Hill
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
UT/Erlanger Oncology & Hematology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Tennessee Cancer Specialists
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909-1327
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center - US Oncology Research
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Texas Oncology - Bedford - US Oncology Reasearch
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Methodist Regional Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Texas Oncology - Baylor - US Oncology Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology - El Paso Cancer Treatment Center Gateway - US Oncology Research
City
El Paso
State/Province
Texas
ZIP/Postal Code
79915
Country
United States
Facility Name
Houston Methodist Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor Scott and White Medical Center
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Texas Oncology - Tyler - US Oncology Research
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - US Oncology Research
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Vista Oncology Inc PS
City
Olympia
State/Province
Washington
ZIP/Postal Code
98506
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
West Virginia University Cancer Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Greenslopes Private Hospital
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
St. John of God Murdoch Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
ZIP/Postal Code
VIC 3168
Country
Australia
Facility Name
Sydney Adventist Hospital
City
Wahroonga
ZIP/Postal Code
NSW 2076
Country
Australia
Facility Name
Westmead Hosptial
City
Westmead
ZIP/Postal Code
NSW 2145
Country
Australia
Facility Name
Klinikum Klagenfurt am Wörthersee
City
Klagenfurt
State/Province
Wörthersee
ZIP/Postal Code
9020
Country
Austria
Facility Name
Medical University Graz
City
Graz
ZIP/Postal Code
17070
Country
Austria
Facility Name
Univ. Klinik für Innere Medizin III der PMU
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Landes-Krankenhaus Steyr
City
Steyr
ZIP/Postal Code
4400
Country
Austria
Facility Name
Faculté de Médecine Campus Erasme
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Clinique Universutaire Saint Luc - Institut Roi Albert II
City
Woluwe-Saint-Lambert
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Centro de Pesquisa Clínica e Ensino Florianópolis LTDA
City
Florianópolis
ZIP/Postal Code
88020
Country
Brazil
Facility Name
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
City
Ijuí
ZIP/Postal Code
98700
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035
Country
Brazil
Facility Name
Hospital São Lucas da PUCRS
City
Porto Alegre
ZIP/Postal Code
90610
Country
Brazil
Facility Name
IRPCc - Instituto Ribeirãopretano de Combate ao Câncer
City
Ribeirão Preto
ZIP/Postal Code
14015-130
Country
Brazil
Facility Name
Oncoclinicas Group Botafogo
City
Rio De Janeiro
ZIP/Postal Code
22250-040
Country
Brazil
Facility Name
Instituto D'Or de Pesquisa e Ensino - Rio De Janeiro
City
Rio De Janeiro
ZIP/Postal Code
22271
Country
Brazil
Facility Name
Groupo Clinicas Oncologicas Integradas (COI) - Barra da Tijuca
City
Rio De Janeiro
ZIP/Postal Code
22775-001
Country
Brazil
Facility Name
Instituto D´Or de Pesquisa e Ensino - Hospital São Rafael
City
São Marcos
ZIP/Postal Code
41253-190
Country
Brazil
Facility Name
Hospital São Rafael
City
São Marcos
ZIP/Postal Code
41253
Country
Brazil
Facility Name
Núcleo de Pesquisa Clínica da Rede São Camilo
City
São Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Facility Name
Onco Star SP Oncologia LTDA
City
São Paulo
ZIP/Postal Code
04543-000
Country
Brazil
Facility Name
Clínica OncoStar - REDE D´OR
City
São Paulo
ZIP/Postal Code
04543
Country
Brazil
Facility Name
London Regional Cancer Program, London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Centre Hospitalier de I'Universitaire de de Montreal (CHUM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke CIUSSS de l'Estrie - CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 1B1
Country
Canada
Facility Name
Sun Yat-sen Memorial Hospital Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150086
Country
China
Facility Name
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430014
Country
China
Facility Name
The First Affiliated Hospital of Xi 'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Linyi Cancer Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276000
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Peking University People'S Hospital
City
Beijing
Country
China
Facility Name
The first hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Guangdong provincial people's hospital
City
Guangzhou
ZIP/Postal Code
510000
Country
China
Facility Name
Jilin Guowen Hospital
City
Jilin
ZIP/Postal Code
136100
Country
China
Facility Name
Shanghai Changhai Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Shanxi Provincial Cancer Hospital
City
Shanxi
ZIP/Postal Code
030013
Country
China
Facility Name
Xingtai People's Hospital
City
Xingtai
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
ZIP/Postal Code
450052
Country
China
Facility Name
Henan Provincial Peoples Hospital
City
Zhengzhou
Country
China
Facility Name
University Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Masaryk Institute of Oncology
City
Brno Střed
ZIP/Postal Code
60200
Country
Czechia
Facility Name
Nemocnice Nový Jičín
City
Nový Jičín
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
University Hospital Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
General University Hospital in Prague
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Nemocnice Na Bulovce
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Hopital haut-Léveque CHU Bordeaux - Service d'Hépato- Gastroentérologie et d'Oncologie digestive
City
Pessac
State/Province
Bordeaux
ZIP/Postal Code
33604
Country
France
Facility Name
Institut de Cancérologie de l'Ouest
City
Angers cedex
ZIP/Postal Code
49055
Country
France
Facility Name
Centre Hospitalier de Bretagne Sud /Site du Scorff
City
Lorient
ZIP/Postal Code
56322
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Service d'Oncologie médicale du Pr. Andre, Hôpital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hôpital Privé des Côtes d'Armor
City
Plérin
ZIP/Postal Code
22190
Country
France
Facility Name
Centre de Lutte Contre le Cancer (CLCC) - Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Clinique Sainte Anne - Groupe Hospitalier Saint-Vincent, Strasbourg Oncologie Libérale
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Klinik fur Gastroenterologie, Hepatologie und Endokrinologie
City
Hannover
Country
Germany
Facility Name
VK und K Studien GbR Landshut-Achdorf
City
Landshut
ZIP/Postal Code
84036
Country
Germany
Facility Name
Bonifatius Hospital Hematology and Oncology
City
Lingen
ZIP/Postal Code
49808
Country
Germany
Facility Name
Carl-von-Basedow-klinikum Saalekrei
City
Merseburg
ZIP/Postal Code
06217
Country
Germany
Facility Name
Klinikum München Bogenhausen, Klinik für Gastroenterologie und Gastroenterologische Onkologie
City
München
ZIP/Postal Code
81925
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
D-89081
Country
Germany
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
National Institute of Oncology
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Bekes County Hospital
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Bacs-Kiskun County Hospital
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Tolna County Hospital
City
Szekszárd
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Jasz-Nagykun-Szolnok County Hospital
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Rambam Health Care Campus, Oncology Institute
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Rabin Medical Center
City
Petah tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Hadassah Medical Center
City
Ramat Gan
ZIP/Postal Code
5268102
Country
Israel
Facility Name
Sheba Pancreatic Cancer Center - SPCC
City
Ramat Gan
Country
Israel
Facility Name
Sourasky Medical Center, Oncology Department
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
A.O. SS Antonio e Biagio e Cesare Arrigo
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Università Campus Bio-Medico di Rome
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina
City
Roma
ZIP/Postal Code
00186
Country
Italy
Facility Name
A.O.U Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Dong-A University Hospital
City
Seogu
State/Province
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Keimyung University, Dongsan hospital
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center, CHA University
City
Seongnam-si
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Mediadvance Clinical
City
Chihuahua
State/Province
Chih.
ZIP/Postal Code
31210
Country
Mexico
Facility Name
Accelerium S de RL de C.V.
City
Monterrey
State/Province
NL
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Centro de Estudios de Alta Especialidad de Sinaloa, ubicado
City
Mazatlán
State/Province
Sinaloa
ZIP/Postal Code
82110
Country
Mexico
Facility Name
Centro de Investigación Médica Aguascalientes (CIMA),
City
Aguascalientes
ZIP/Postal Code
20116
Country
Mexico
Facility Name
Clinstile S.A. de C.V.,
City
Cuauhtémoc
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Phylasis Clinicas Research S. de R.L. de C.V.
City
Cuautitlán Izcalli
ZIP/Postal Code
54769
Country
Mexico
Facility Name
Hospitales Star Medica - Luna Parc
City
Estado De México
ZIP/Postal Code
54750
Country
Mexico
Facility Name
Universidad Autonoma de Nuevo Leon - Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Oncocenter - Puebla
City
Puebla
ZIP/Postal Code
72530
Country
Mexico
Facility Name
Hospital Angeles San Luis
City
San Luis Potosí
ZIP/Postal Code
78200
Country
Mexico
Facility Name
Centro Potosino de Investigación Médica SC,
City
San Luis Potosí
ZIP/Postal Code
78250
Country
Mexico
Facility Name
Centro Hemato-Oncologico Privado CHOP
City
Toluca de Lerdo
ZIP/Postal Code
50080
Country
Mexico
Facility Name
Phylasis Clinicas Research S.de R.L. de C.V. (PCR)-Toluca
City
Toluca De Lerdo
ZIP/Postal Code
50180
Country
Mexico
Facility Name
FAICIC Clinical Research
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
Oncology Clinic Clinical Hospital of Przemienienia Pańskiego UM in Poznaniu
City
Poznań
ZIP/Postal Code
60-596
Country
Poland
Facility Name
Centrum Medyczne MrukMed
City
Rzeszów
ZIP/Postal Code
35-021
Country
Poland
Facility Name
Oncology and Radiotherapy Clinic, Oncology Center - Institute
City
Warsaw
ZIP/Postal Code
02-034
Country
Poland
Facility Name
Oncology and Radiotherapy Clinic University Clinical Center Non-Invasive Medicine Center
City
Warsaw
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Jan Mikulicz-Radecki University Teaching Hospital
City
Wrocław
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Instituto Oncòlogico Dr. Rosell
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Vall d´Hebron University Hospital
City
Barcelona
Country
Spain
Facility Name
Hospital General Universitario de Elche
City
Elche
Country
Spain
Facility Name
HM Hospitales - Centro Integral Oncologico Clara Campal - CIOCC
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Regional Universitario de Málaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Clinica Universiatria de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
Country
Spain
Facility Name
Instituto Valenciano de Oncología IVO
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hôpital Fribourgeois/Freiburger Spital
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
Facility Name
KS Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland

12. IPD Sharing Statement

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Learn more about this trial

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)

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