ENGOT-ov50 / GOG-3029 / INNOVATE-3: Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 200kHz) Concomitant With Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer
Who is this study for? Patients with recurrent ovarian cancer
Status: Completed
Location: See all (114) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) concomitant with weekly paclitaxel for the treatment of recurrent ovarian cancer . 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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 18 years of age and older
• Epithelial histology of ovarian/primary peritoneal or fallopian tube carcinoma at the time of diagnosis
• Life expectancy of ≥ 12 weeks
• Maximum two prior lines of systemic therapy following diagnosis of platinum-resistance
• Maximum total of 5 prior lines of systemic therapy
• Amenable to receive weekly paclitaxel and able to operate the NovoTTF-100L(O) System
• ECOG 0-1
• Evaluable (measurable or non-measurable) disease in the abdominal/pelvic region per RECIST V1.
• Signed informed consent form for the study protocol
Locations
United States
Arizona
Arizona Oncology- Biltmore Cancer Center
Phoenix
Arizona Oncology
Tucson
California
University of California
La Jolla
Hoag Memorial Hospital Presbyterian
Newport Beach
California Pacific Medical Center- Pacific Campus
San Francisco
Olive View - UCLA Medical Center
Sylmar
Colorado
Rocky Mountain Cancer Centers
Aurora
University of Colorado Denver
Aurora
Rocky Mountain Cancer Centers
Boulder
Rocky Mountain Cancer Centers
Colorado Springs
Rocky Mountain Cancer Centers
Denver
Rocky Mountain Cancer Centers
Denver
Rocky Mountain Cancer Centers
Lakewood
Rocky Mountain Cancer Centers
Littleton
Rocky Mountain Cancer Centers
Lone Tree
Rocky Mountain Cancer Centers
Longmont
Rocky Mountain Cancer Centers
Parker
Rocky Mountain Cancer Centers
Pueblo
Rocky Mountain Cancer Centers
Thornton
Florida
Broward Health Medical Center
Fort Lauderdale
AdventHealth Cancer Institute
Orlando
Georgia
Northeast Georgia Medical Center
Gainesville
Iowa
Des Moines Oncology Research Association
Des Moines
Illinois
Rush University Cancer Center - Chicago and Innovation
Chicago
Kentucky
Norton Cancer Institute
Louisville
Massachusetts
Lahey Hospital & Medical Center
Burlington
Maryland
Maryland Oncology Hematology, P.A.
Silver Spring
Minnesota
Minnesota Oncology Hematology, PA
Saint Paul
Missouri
Washington University School of Medicine in St. Louis
Saint Louis
North Carolina
Wake Forest Baptist Medical Center
Winston-salem
Nebraska
Methodist Estabrook Cancer Center
Omaha
New Jersey
MD Anderson Cancer Center at Cooper
Camden
The Valley Hospital
Paramus
Nevada
Women's Cancer Center of Nevada
Las Vegas
Center of Hope at Renown Medical Center
Reno
Ohio
Miami Valley Hospital South
Centerville
The Ohio State University Wexner Medical Center
Columbus
Oregon
Northwest Cancer Specialists, PC
Portland
Pennsylvania
UPMC Cancer Center
Pittsburgh
West Penn OB/GYN
Pittsburgh
Abington Hospital- Asplundh Cancer Pavilion
Willow Grove
Rhode Island
Women & Infants Hospital of Rhode Island
Providence
South Dakota
Sanford Gynecologic Oncology Clinic
Sioux Falls
Texas
Texas Oncology Austin-Balcones
Austin
Texas Oncology Austin-Midtown
Austin
Texas Oncology Austin-North Austin
Austin
Texas Oncology
Dallas
University of Texas Southwestern Medical Center
Dallas
Texas Oncology-Fort Worth
Fort Worth
The University of Texas Medical School at Houston
Houston
Texas Oncology-McAllen
Mcallen
Texas Oncology San Antonio Medical Center
San Antonio
Texas Oncology - Sugar Land
Sugar Land
Texas Oncology
The Woodlands
Texas Oncology-Tyler
Tyler
Texas Oncology-Deke Slayton Cancer Center
Webster
Virginia
Virginia Oncology Associates
Norfolk
Carilion Clinic-Gynecologic Oncology
Roanoke
Washington
Multicare Institute for Research and Innovation
Tacoma
Other Locations
Austria
KH der Barmherzigen Brüder Graz
Graz
Univ.-Klinik für Gynäkologie und Geburtshilfe
Graz
Univ.-Klinik für Gynäkologie und Geburtshilfe, Innsbruck
Innsbruck
Landesfrauenklinik Salzburg
Salzburg
Belgium
Imelda Ziekenhuis Bonheiden
Bonheiden
Cliniques Universitaires Saint Luc, Institut Roi Albert II
Brussel
Grand Hôpital de Charleroi, Oncologie-Hématologie
Charleroi
AZ Maria Middelares, Clinical Trial Unit Medical Oncology - Integrated Cancer Center Ghent
Gent
UZ Gent
Gent
University Hospitals Leuven, Leuven Cancer Institute
Leuven
CHU Ambroise Paré
Mons
CHU UCL Namur - Site Ste Elisabeth
Namur
Canada
Tom Baker Cancer Center
Calgary
Centre Hospitalie
Montréal
Jewish General Hospital
Montréal
McGill University Health Centre
Montréal
CancerCare Manitoba
Winnipeg
Germany
Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Gynäkologie
Berlin
Universitätsklinikum Carl Gustav Carus
Dresden
Horst-Schmidt-Kliniken, Gynecology and Gynecologic, Oncology Department
Wiesbaden
Hungary
Nőgyógyászati Osztály, Országos Onkológiai Intézet
Budapest
Semmelweis University
Budapest
Szuleszeti és Nogyogyaszati Klinika
Debrecen
Israel
Hillel Yaffe Medical Center
Hadera
Saare Zedek Medical Center - Gyneco-Oncology
Jerusalem
Oncology Institute, Galilee Medical Center
Nahariya
Gyneco-Oncology Chaim Sheba Medical Center
Ramat Gan
Italy
Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii
Bologna
Presidio Ospedaliero Antonio Perrino - ASL Brindisi
Brindisi
ASST Lecco - Ospedale Manzoni, Dipartimento Oncologico
Lecco
Dipartimento Medicina e Chirurgia, Università Milano-Bicocca, Direttore Programma Ginecologia Oncologica, Istituto Europeo Oncologia
Milano
IRCCS Ospedale San Raffaele, U.O. Ginecologia-Ematologia e TMO
Milano
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli
Fondazione Policlinico Universitario Gemelli
Roma
University Saint Anna
Torino
Netherlands
Amsterdam Universitair Medische centra
Amsterdam
University Medical Center Utrech
Utrecht
Poland
Szpitale Pomorskie Sp. z o.o.
Gdynia
Oddział Kliniczny Chirurgii Ogólnej i Onkologicznej, Szpital Św. Rafała
Kraków
Uniwersytet Medyczny w Lublinie, I Klinika Ginekologii Onkologicznej i Ginekologii
Lublin
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie, Oddział Kliniczny Onkologii i Immunoonkologii z Ośrodkiem Dziennym Terapii Onkologicznej
Olsztyn
Oddział Ginekologii Onkologicznej Katedry i Kliniki Onkologii Uniwersytetu Medycznego w Poznaniu
Poznań
Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie, Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt
Szczecin
Szpital Kliniczny im. ks. Anny Mazowieckiej
Warsaw
Spain
Servicio de Oncología Médica, Hospital Universitario Quirón Dexeus
Barcelona
lnstitut Catala d'Oncologia, Hospital Universitario Dr. Josep Trueta, Servicio de Oncologia,
Girona
Clinica Universidad de Navarra en Madrid
Madrid
Hospital 12 de Octubre. Servicio Oncología Médica
Madrid
Hospital MD Anderson Cancer Center
Madrid
Hospital Universitario Ramon y Cajal, Servicio de Oncologia Médica
Madrid
Fundació Institut d'Investigació Sanitària Illes Balears - IdISBa, Hospital Universitari Son Espases
Palma De Mallorca
Switzerland
Gynecological Tumor Center, University Hospital Basel
Basel
IOSI Bellinzona, Oncology Institute of Southern Switzerland, Ospedale San Giovanni
Bellinzona
Kantonsspital Frauenfeld - Frauenklinik
Frauenfeld
UniversitätsSpital Zürich - Klinik für Gynäkologie
Zürich
Time Frame
Start Date: 2019-03-22
Completion Date: 2023-05-18
Participants
Target number of participants: 540
Treatments
Experimental: NovoTTF-100L(O)
Patients receive TTFields using the NovoTTF-100L(O) System together with weekly Paclitaxel
Active_comparator: Best Standard of Care
Patients receive best standard of care with weekly Paclitaxel
Authors
Pia Wolfrum-Ristau, Erin Salinas, David Warshal, Robert Behrens, David Iglesias, Samuel Lentz, Mark Shahin, Carolyn Matthews, Thomas Krivak, Alberto Mendivil, Maria Bell, Herbert Newton, Brent Tierney, Joseph Buscema, Bradley Corr, Christine Holschneider, Michael Guy, Brian Slomovitz, Corrine Zarwan, John Chan, Premal Thaker, Donald Richards, Michael McCollum, Katina Robison, Peter Lim, Mary Gordinier, Noelle Cloven, Sami Diab, Jayanthi Lea, Nurul Wahid, Alexander Olawaiye, Nicola Spirtos, Andrew Green, Jessica Thomes-Pepin, Antonio Santillan-Gomez, Jalid Sehouli, Pauline Wimberger, Raul Marquez, Bradley Monk, Cheryl Aylesworth, Jean-Marie Stephan, Kristy Ward, Petr Valha, Antonio Ardizzoia, Maria Del Grande, Lionel D'Hondt, Mathias Fehr, Lubomir Bodnar, Eleftherios Pierre Samartzis, Michael Eichbaum, Jesus Alarcon, Eva Guerra, Jacob Korach, Paolo Zola, Ilan Bruchim, Heidi Van den Bulck, Viola Heinzelmann-Schwarz, Ignace Vergote, Christian Schauer, Christian Marth, Ora Solange Rosengarten, Lukas Rob, Sandro Pignata, Jean-François Baurain, Edgar Petru, Hannelore Denys, Radosław Mądry, David Cibula, Nicoletta Colombo, Peter Vuylsteke, Giorgia Mangili, Stephanie Henry, Toon Van Gorp, Claudio Zamagni, Ayelet Shai, Susie Lau, Saverio Cinieri, Bohuslav Melichar, Christof Vulsteke, Robert Poka, Jaroslav Klat, Giovanni Scambia
Related Therapeutic Areas
Sponsors
Leads: NovoCure Ltd.