Effect of Tumor Treating Fields (TTFields, 200 kHz) Concomitant With Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer (ENGOT-ov50 / GOG-3029 / INNOVATE-3)
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
1 other identifier
interventional
540
13 countries
119
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 ovarian-cancer
Started Mar 2019
119 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 22, 2019
CompletedFirst Submitted
Initial submission to the registry
April 29, 2019
CompletedFirst Posted
Study publicly available on registry
May 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2023
CompletedMarch 29, 2024
March 1, 2024
4.2 years
April 29, 2019
March 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
4 years
Secondary Outcomes (7)
Progression-free survival
4 years
Objective response rate
4 years
Next progression-free survival
4 years
Time to undisputable deterioration in health-related quality of life (HRQoL)
4 years
Time to first and second subsequent treatment
4 years
- +2 more secondary outcomes
Study Arms (2)
NovoTTF-100L(O)
EXPERIMENTALPatients receive TTFields using the NovoTTF-100L(O) System together with weekly Paclitaxel
Best Standard of Care
ACTIVE COMPARATORPatients receive best standard of care with weekly Paclitaxel
Interventions
Patients receive continuous TTFields treatment using the NovoTTF-100L(O) device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the abdomen/pelvis. The treatment enables the patient to maintain regular daily routine.
Paclitaxel 80 mg/m\^2 intravenous infusion will be administered weekly for 8 weeks and then on Days 1, 8 and 15 of each subsequent 28-day cycle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Primary platinum-refractory disease (progression per RECIST V1.1 during or within 1 month after first line therapy), while secondary platinum-refractory disease is allowed
- Prior disease progression on a weekly paclitaxel for recurrent disease
- Brain metastasis or leptomeningeal spread of the tumor
- Albumin level \<25 gram/liter (subjects should not receive total parenteral nutrition or albumin within 2 weeks of the test)
- CTCAE V5.0 Grade 3 or higher peripheral neuropathy
- Implantable electrical medical devices
- Known allergies to medical adhesives or hydrogel
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to paclitaxel or drugs similar or related to paclitaxel, except for cases that were able to undergo desensitization per investigator
- Serious co-morbidities
- Concurrent anti-tumor therapy beyond weekly paclitaxel, excluding hormonal therapy for breast cancer
- Concurrent active treatment in another clinical trial. However prior participation in clinical trials is allowed as well as participation during survival follow-up
- 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
- Admitted to an institution by administrative or court order
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NovoCure Ltd.lead
Study Sites (119)
Arizona Oncology- Biltmore Cancer Center
Phoenix, Arizona, 85016, United States
Arizona Oncology
Tucson, Arizona, 85711, United States
University of California
La Jolla, California, 92093-1503, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
California Pacific Medical Center- Pacific Campus
San Francisco, California, 94109, United States
Olive View - UCLA Medical Center
Sylmar, California, 91342, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012, United States
University of Colorado Denver
Aurora, Colorado, 80045-2517, United States
Rocky Mountain Cancer Centers
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80220, United States
Rocky Mountain Cancer Centers
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers
Littleton, Colorado, 80120-4413, United States
Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Centers
Longmont, Colorado, 80501, United States
Rocky Mountain Cancer Centers
Parker, Colorado, 80138, United States
Rocky Mountain Cancer Centers
Pueblo, Colorado, 81008, United States
Rocky Mountain Cancer Centers
Thornton, Colorado, 80260, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
AdventHealth Cancer Institute
Orlando, Florida, 32804, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Rush University Cancer Center - Chicago and Innovation
Chicago, Illinois, 60612-3833, United States
Des Moines Oncology Research Association
Des Moines, Iowa, 50309, United States
Norton Cancer Institute
Louisville, Kentucky, 40202-2025, United States
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland, 20902, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805, United States
Minnesota Oncology Hematology, PA
Saint Paul, Minnesota, 55102, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110-1010, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, 68114-4108, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169, United States
Center of Hope at Renown Medical Center
Reno, Nevada, 89502, United States
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103, United States
The Valley Hospital
Paramus, New Jersey, 07652, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Miami Valley Hospital South
Centerville, Ohio, 45459-447, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210-1240, United States
Northwest Cancer Specialists, PC
Portland, Oregon, 97227, United States
West Penn OB/GYN
Pittsburgh, Pennsylvania, 15212, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Abington Hospital- Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19001-3720, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905-2401, United States
Sanford Gynecologic Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Texas Oncology Austin-Balcones
Austin, Texas, 78731, United States
Texas Oncology Austin-Midtown
Austin, Texas, 78745, United States
Texas Oncology Austin-North Austin
Austin, Texas, 78758, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75216, United States
Texas Oncology
Dallas, Texas, 75246, United States
Texas Oncology-Fort Worth
Fort Worth, Texas, 76104-2150, United States
The University of Texas Medical School at Houston
Houston, Texas, 77030-1501, United States
Texas Oncology-McAllen
McAllen, Texas, 78503, United States
Texas Oncology San Antonio Medical Center
San Antonio, Texas, 78240, United States
Texas Oncology - Sugar Land
Sugar Land, Texas, 77479-4308, United States
Texas Oncology
The Woodlands, Texas, 77380, United States
Texas Oncology-Tyler
Tyler, Texas, 75702, United States
Texas Oncology-Deke Slayton Cancer Center
Webster, Texas, 77598, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Carilion Clinic-Gynecologic Oncology
Roanoke, Virginia, 24016-4962, United States
Multicare Institute for Research and Innovation
Tacoma, Washington, 98405, United States
KH der Barmherzigen Brüder Graz
Graz, 8020, Austria
Univ.-Klinik für Gynäkologie und Geburtshilfe
Graz, 8036, Austria
Univ.-Klinik für Gynäkologie und Geburtshilfe, Innsbruck
Innsbruck, Austria
Landesfrauenklinik Salzburg
Salzburg, 5020, Austria
Imelda Ziekenhuis Bonheiden
Bonheiden, 2820, Belgium
Cliniques Universitaires Saint Luc, Institut Roi Albert II
Brussels, 1200, Belgium
Grand Hôpital de Charleroi, Oncologie-Hématologie
Charleroi, 6000, Belgium
AZ Maria Middelares, Clinical Trial Unit Medical Oncology - Integrated Cancer Center Ghent
Ghent, 9000, Belgium
UZ Gent
Ghent, 9000, Belgium
University Hospitals Leuven, Leuven Cancer Institute
Leuven, Belgium
CHU Ambroise Paré
Mons, 7000, Belgium
CHU UCL Namur - Site Ste Elisabeth
Namur, 5000, Belgium
CancerCare Manitoba
Winnipeg, Manitoba, R3E)V9, Canada
Centre Hospitalie
Montreal, Quebec, H2X 0A9, Canada
Tom Baker Cancer Center
Calgary, H2L 4M1, Canada
McGill University Health Centre
Montreal, H4A 3J1, Canada
Jewish General Hospital
Montreal, QC H3T 1E2, Canada
Gynekologicko-porodnické oddělení - Nemocnice České Budějovice a.s.
České Budějovice, 370 01, Czechia
Onkologická Klinika Fakultní nemocnice Olomouc
Olomouc, 779 00, Czechia
University Hospital Ostrava
Ostrava-Poruba, 708 52, Czechia
Gynekologicko-porodnická klinika, Fakultní nemocnice Královské Vinohrady
Prague, 100 34, Czechia
Gynekologicko-porodnická klinika 1. LF UK a VFN
Prague, 128 01, Czechia
Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Gynäkologie
Berlin, 1200, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, 01307, Germany
Horst-Schmidt-Kliniken, Gynecology and Gynecologic, Oncology Department
Wiesbaden, 65199, Germany
Semmelweis University
Budapest, 1085, Hungary
Nőgyógyászati Osztály, Országos Onkológiai Intézet
Budapest, 1122, Hungary
Szuleszeti és Nogyogyaszati Klinika
Debrecen, 4032, Hungary
Hillel Yaffe Medical Center
Hadera, 38100, Israel
Saare Zedek Medical Center - Gyneco-Oncology
Jerusalem, 9103102, Israel
Oncology Institute, Galilee Medical Center
Nahariya, 22100, Israel
Gyneco-Oncology Chaim Sheba Medical Center
Ramat Gan, 5265601, Israel
Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii
Bologna, 40138, Italy
Presidio Ospedaliero Antonio Perrino - ASL Brindisi
Brindisi, 72100, Italy
ASST Lecco - Ospedale Manzoni, Dipartimento Oncologico
Lecco, 23900, Italy
Dipartimento Medicina e Chirurgia, Università Milano-Bicocca, Direttore Programma Ginecologia Oncologica, Istituto Europeo Oncologia
Milan, 20141, Italy
IRCCS Ospedale San Raffaele, U.O. Ginecologia-Ematologia e TMO
Milan, 60 20132, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli, 80130, Italy
Fondazione Policlinico Universitario Gemelli
Roma, 00168, Italy
University Saint Anna
Torino, 10126, Italy
Amsterdam Universitair Medische centra
Amsterdam, 1105, Netherlands
University Medical Center Utrech
Utrecht, 3508, Netherlands
Szpitale Pomorskie Sp. z o.o.
Gdynia, 81-519, Poland
Oddział Kliniczny Chirurgii Ogólnej i Onkologicznej, Szpital Św. Rafała
Krakow, 30-693, Poland
Uniwersytet Medyczny w Lublinie, I Klinika Ginekologii Onkologicznej i Ginekologii
Lublin, 20-081, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie, Oddział Kliniczny Onkologii i Immunoonkologii z Ośrodkiem Dziennym Terapii Onkologicznej
Olsztyn, 10-228, Poland
Oddział Ginekologii Onkologicznej Katedry i Kliniki Onkologii Uniwersytetu Medycznego w Poznaniu
Poznan, 60-569, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie, Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt
Szczecin, 70-111, Poland
Szpital Kliniczny im. ks. Anny Mazowieckiej
Warsaw, 00-315, Poland
Servicio de Oncología Médica, Hospital Universitario Quirón Dexeus
Barcelona, 08028, Spain
lnstitut Catala d'Oncologia, Hospital Universitario Dr. Josep Trueta, Servicio de Oncologia,
Girona, 17007, Spain
Clinica Universidad de Navarra en Madrid
Madrid, 28027, Spain
Hospital MD Anderson Cancer Center
Madrid, 28033, Spain
Hospital Universitario Ramon y Cajal, Servicio de Oncologia Médica
Madrid, 28034, Spain
Hospital 12 de Octubre. Servicio Oncología Médica
Madrid, 28041, Spain
Fundació Institut d'Investigació Sanitària Illes Balears - IdISBa, Hospital Universitari Son Espases
Palma de Mallorca, 07120, Spain
Gynecological Tumor Center, University Hospital Basel
Basel, 4031, Switzerland
IOSI Bellinzona, Oncology Institute of Southern Switzerland, Ospedale San Giovanni
Bellinzona, 6500, Switzerland
Kantonsspital Frauenfeld - Frauenklinik
Frauenfeld, 8501, Switzerland
UniversitätsSpital Zürich - Klinik für Gynäkologie
Zurich, 8091, Switzerland
Related Publications (9)
Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.
PMID: 15126372BACKGROUNDKirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5.
PMID: 17551011BACKGROUNDStupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbaly V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.
PMID: 22608262BACKGROUNDKirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.
PMID: 19387848BACKGROUNDGiladi M, Schneiderman RS, Voloshin T, Porat Y, Munster M, Blat R, Sherbo S, Bomzon Z, Urman N, Itzhaki A, Cahal S, Shteingauz A, Chaudhry A, Kirson ED, Weinberg U, Palti Y. Mitotic Spindle Disruption by Alternating Electric Fields Leads to Improper Chromosome Segregation and Mitotic Catastrophe in Cancer Cells. Sci Rep. 2015 Dec 11;5:18046. doi: 10.1038/srep18046.
PMID: 26658786BACKGROUNDStupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.
PMID: 26670971BACKGROUNDStupp 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.
PMID: 29260225BACKGROUNDVergote I, von Moos R, Manso L, Van Nieuwenhuysen E, Concin N, Sessa C. Tumor Treating Fields in combination with paclitaxel in recurrent ovarian carcinoma: Results of the INNOVATE pilot study. Gynecol Oncol. 2018 Sep;150(3):471-477. doi: 10.1016/j.ygyno.2018.07.018. Epub 2018 Jul 27.
PMID: 30060963BACKGROUNDTaphoorn MJB, Dirven L, Kanner AA, Lavy-Shahaf G, Weinberg U, Taillibert S, Toms SA, Honnorat J, Chen TC, Sroubek J, David C, Idbaih A, Easaw JC, Kim CY, Bruna J, Hottinger AF, Kew Y, Roth P, Desai R, Villano JL, Kirson ED, Ram Z, Stupp R. Influence of Treatment With Tumor-Treating Fields on Health-Related Quality of Life of Patients With Newly Diagnosed Glioblastoma: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Apr 1;4(4):495-504. doi: 10.1001/jamaoncol.2017.5082.
PMID: 29392280BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ignace Vergote, MD
University Hospitals Leuven, Leuven Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2019
First Posted
May 7, 2019
Study Start
March 22, 2019
Primary Completion
May 18, 2023
Study Completion
May 18, 2023
Last Updated
March 29, 2024
Record last verified: 2024-03