- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03940196
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
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 ovarian carcinoma 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. In addition, TTFields have shown to inhibit metastatic spread of malignant melanoma in in vivo experiment.
In a pilot study, 31 patients with recurrent platinum-resistant ovarian carcinoma received paclitaxel together with TTFields (200 kHz) applied to the abdomen/pelvis 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). 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.
DESCRIPTION OF THE TRIAL:
All patients included in this trial are patients with platinum-resistant ovarian carcinoma. In addition, all patients must meet all eligibility criteria.
Eligible patients will be randomly assigned to one of two groups:
- Patients receive TTFields at 200 kHz to the abdomen and pelvis using the NovoTTF-100L(O) System together with weekly paclitaxel.
- Patients receive weekly paclitaxel alone.
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-100L(O) group, the patients will be treated continuously with the device until progression in the abdomen/pelvis. On both arms, patients who have progression outside the abdomen/pelvis 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 (200 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 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 could potentially become treatment for ovarian cancer with very few side effects.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Graz, Austria, 8020
- KH der Barmherzigen Brüder Graz
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Graz, Austria, 8036
- Univ.-Klinik für Gynäkologie und Geburtshilfe
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Innsbruck, Austria
- Univ.-Klinik für Gynäkologie und Geburtshilfe, Innsbruck
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Salzburg, Austria, 5020
- Landesfrauenklinik Salzburg
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Bonheiden, Belgium, 2820
- Imelda Ziekenhuis Bonheiden
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Brussel, Belgium, 1200
- Cliniques Universitaires Saint Luc, Institut Roi Albert II
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Charleroi, Belgium, 6000
- Grand Hôpital de Charleroi, Oncologie-Hématologie
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Gent, Belgium, 9000
- UZ Gent
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Gent, Belgium, 9000
- AZ Maria Middelares, Clinical Trial Unit Medical Oncology - Integrated Cancer Center Ghent
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Leuven, Belgium
- University Hospitals Leuven, Leuven Cancer Institute
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Mons, Belgium, 7000
- CHU Ambroise Paré
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Namur, Belgium, 5000
- CHU UCL Namur - Site Ste Elisabeth
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Calgary, Canada, H2L 4M1
- Tom Baker Cancer Center
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Montréal, Canada, H4A 3J1
- McGill University Health Centre
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Montréal, Canada, QC H3T 1E2
- Jewish General Hospital
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Manitoba
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Winnipeg, Manitoba, Canada, R3E)V9
- CancerCare Manitoba
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Quebec
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Montréal, Quebec, Canada, H2X 0A9
- Centre Hospitalie
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Olomouc, Czechia, 779 00
- Onkologická klinika Fakultní nemocnice Olomouc
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Ostrava-Poruba, Czechia, 708 52
- University Hospital Ostrava
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Praha 10, Czechia, 100 34
- Gynekologicko-porodnická klinika, Fakultní nemocnice Královské Vinohrady
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Praha 2, Czechia, 128 01
- Gynekologicko-porodnická klinika 1. LF UK a VFN
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České Budějovice, Czechia, 370 01
- Gynekologicko-porodnické oddělení - Nemocnice České Budějovice a.s.
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Berlin, Germany, 1200
- Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Gynäkologie
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Dresden, Germany, 01307
- Universitätsklinikum Carl Gustav Carus
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Wiesbaden, Germany, 65199
- Horst-Schmidt-Kliniken, Gynecology and Gynecologic, Oncology Department
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Budapest, Hungary, 1085
- Semmelweis University
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Budapest, Hungary, 1122
- Nőgyógyászati Osztály, Országos Onkológiai Intézet
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Debrecen, Hungary, 4032
- Szuleszeti és Nogyogyaszati Klinika
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Hadera, Israel, 38100
- Hillel Yaffe Medical Center
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Jerusalem, Israel, 9103102
- Saare Zedek Medical Center - Gyneco-Oncology
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Nahariya, Israel, 22100
- Oncology Institute, Galilee Medical Center
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Ramat Gan, Israel, 5265601
- Gyneco-Oncology Chaim Sheba Medical Center
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Bologna, Italy, 40138
- Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii
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Brindisi, Italy, 72100
- Presidio Ospedaliero Antonio Perrino - ASL Brindisi
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Lecco, Italy, 23900
- ASST Lecco - Ospedale Manzoni, Dipartimento Oncologico
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Milano, Italy, 20141
- Dipartimento Medicina e Chirurgia, Università Milano-Bicocca, Direttore Programma Ginecologia Oncologica, Istituto Europeo Oncologia
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Milano, Italy, 60 20132
- IRCCS Ospedale San Raffaele, U.O. Ginecologia-Ematologia e TMO
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Napoli, Italy, 80130
- Istituto Nazionale Tumori IRCCS Fondazione Pascale
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Roma, Italy, 00168
- Fondazione Policlinico Universitario Gemelli
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Torino, Italy, 10126
- University Saint Anna
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Amsterdam, Netherlands, 1105
- Amsterdam Universitair Medische Centra
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Utrecht, Netherlands, 3508
- University Medical Center Utrech
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Gdynia, Poland, 81-519
- Szpitale Pomorskie Sp. z o.o.
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Kraków, Poland, 30-693
- Oddział Kliniczny Chirurgii Ogólnej i Onkologicznej, Szpital Św. Rafała
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Lublin, Poland, 20-081
- Uniwersytet Medyczny w Lublinie, I Klinika Ginekologii Onkologicznej i Ginekologii
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Olsztyn, Poland, 10-228
- Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie, Oddział Kliniczny Onkologii i Immunoonkologii z Ośrodkiem Dziennym Terapii Onkologicznej
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Poznań, Poland, 60-569
- Oddział Ginekologii Onkologicznej Katedry i Kliniki Onkologii Uniwersytetu Medycznego w Poznaniu
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Szczecin, Poland, 70-111
- Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie, Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt
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Warsaw, Poland, 00-315
- Szpital Kliniczny im. Ks. Anny Mazowieckiej
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Barcelona, Spain, 08028
- Servicio de Oncología Médica, Hospital Universitario Quirón Dexeus
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Girona, Spain, 17007
- lnstitut Catala d'Oncologia, Hospital Universitario Dr. Josep Trueta, Servicio de Oncologia,
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Madrid, Spain, 28027
- Clinica Universidad de Navarra en Madrid
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Madrid, Spain, 28033
- Hospital MD Anderson Cancer Center
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Madrid, Spain, 28034
- Hospital Universitario Ramón y Cajal, Servicio de Oncologia Médica
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Madrid, Spain, 28041
- Hospital 12 de Octubre. Servicio Oncología Médica
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Palma De Mallorca, Spain, 07120
- Fundació Institut d'Investigació Sanitària Illes Balears - IdISBa, Hospital Universitari Son Espases
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Basel, Switzerland, 4031
- Gynecological Tumor Center, University Hospital Basel
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Bellinzona, Switzerland, 6500
- IOSI Bellinzona, Oncology Institute of Southern Switzerland, Ospedale San Giovanni
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Frauenfeld, Switzerland, 8501
- Kantonsspital Frauenfeld - Frauenklinik
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Zürich, Switzerland, 8091
- UniversitätsSpital Zürich - Klinik für Gynäkologie
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Arizona
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Phoenix, Arizona, United States, 85016
- Arizona Oncology- Biltmore Cancer Center
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Tucson, Arizona, United States, 85711
- Arizona Oncology
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California
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La Jolla, California, United States, 92093-1503
- University of California
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Newport Beach, California, United States, 92663
- Hoag Memorial Hospital Presbyterian
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San Francisco, California, United States, 94109
- California Pacific Medical Center- Pacific Campus
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Sylmar, California, United States, 91342
- Olive View - UCLA Medical Center
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Colorado
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Aurora, Colorado, United States, 80012
- Rocky Mountain Cancer Centers
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Aurora, Colorado, United States, 80045-2517
- University of Colorado Denver
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Boulder, Colorado, United States, 80303
- Rocky Mountain Cancer Centers
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Colorado Springs, Colorado, United States, 80907
- Rocky Mountain Cancer Centers
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Denver, Colorado, United States, 80218
- Rocky Mountain Cancer Centers
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Denver, Colorado, United States, 80220
- Rocky Mountain Cancer Centers
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Lakewood, Colorado, United States, 80228
- Rocky Mountain Cancer Centers
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Littleton, Colorado, United States, 80120-4413
- Rocky Mountain Cancer Centers
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Lone Tree, Colorado, United States, 80124
- Rocky Mountain Cancer Centers
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Longmont, Colorado, United States, 80501
- Rocky Mountain Cancer Centers
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Parker, Colorado, United States, 80138
- Rocky Mountain Cancer Centers
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Pueblo, Colorado, United States, 81008
- Rocky Mountain Cancer Centers
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Thornton, Colorado, United States, 80260
- Rocky Mountain Cancer Centers
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Florida
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Fort Lauderdale, Florida, United States, 33316
- Broward Health Medical Center
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Orlando, Florida, United States, 32804
- AdventHealth Cancer Institute
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Georgia
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Gainesville, Georgia, United States, 30501
- Northeast Georgia Medical Center
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Illinois
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Chicago, Illinois, United States, 60612-3833
- Rush University Cancer Center - Chicago and Innovation
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Iowa
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Des Moines, Iowa, United States, 50309
- Des Moines Oncology Research Association
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Kentucky
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Louisville, Kentucky, United States, 40202-2025
- Norton Cancer Institute
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Maryland
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Silver Spring, Maryland, United States, 20902
- Maryland Oncology Hematology, P.A.
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Massachusetts
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Burlington, Massachusetts, United States, 01805
- Lahey Hospital & Medical Center
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Minnesota
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Saint Paul, Minnesota, United States, 55102
- Minnesota Oncology Hematology, Pa
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Missouri
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Saint Louis, Missouri, United States, 63110-1010
- Washington University School of Medicine in St. Louis
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Nebraska
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Omaha, Nebraska, United States, 68114-4108
- Methodist Estabrook Cancer Center
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Nevada
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Las Vegas, Nevada, United States, 89169
- Women's Cancer Center of Nevada
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Reno, Nevada, United States, 89502
- Center of Hope at Renown Medical Center
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New Jersey
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Camden, New Jersey, United States, 08103
- MD Anderson Cancer Center at Cooper
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Paramus, New Jersey, United States, 07652
- The Valley Hospital
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Medical Center
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Ohio
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Centerville, Ohio, United States, 45459-447
- Miami Valley Hospital South
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Columbus, Ohio, United States, 43210-1240
- The Ohio State University Wexner Medical Center
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Oregon
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Portland, Oregon, United States, 97227
- Northwest Cancer Specialists, PC
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- UPMC Cancer Center
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Pittsburgh, Pennsylvania, United States, 15212
- West Penn OB/GYN
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Willow Grove, Pennsylvania, United States, 19001-3720
- Abington Hospital- Asplundh Cancer Pavilion
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Rhode Island
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Providence, Rhode Island, United States, 02905-2401
- Women & Infants Hospital of Rhode Island
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South Dakota
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Sioux Falls, South Dakota, United States, 57104
- Sanford Gynecologic Oncology Clinic
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Texas
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Austin, Texas, United States, 78731
- Texas Oncology Austin-Balcones
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Austin, Texas, United States, 78745
- Texas Oncology Austin-Midtown
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Austin, Texas, United States, 78758
- Texas Oncology Austin-North Austin
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Dallas, Texas, United States, 75246
- Texas Oncology
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Dallas, Texas, United States, 75216
- University of Texas Southwestern Medical Center
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Fort Worth, Texas, United States, 76104-2150
- Texas Oncology-Fort Worth
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Houston, Texas, United States, 77030-1501
- The University of Texas Medical School at Houston
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McAllen, Texas, United States, 78503
- Texas Oncology-McAllen
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San Antonio, Texas, United States, 78240
- Texas Oncology San Antonio Medical Center
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Sugar Land, Texas, United States, 77479-4308
- Texas Oncology - Sugar Land
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The Woodlands, Texas, United States, 77380
- Texas Oncology
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Tyler, Texas, United States, 75702
- Texas Oncology-Tyler
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Webster, Texas, United States, 77598
- Texas Oncology-Deke Slayton Cancer Center
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Virginia
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Norfolk, Virginia, United States, 23502
- Virginia Oncology Associates
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Roanoke, Virginia, United States, 24016-4962
- Carilion Clinic-Gynecologic Oncology
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Washington
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Tacoma, Washington, United States, 98405
- MultiCare Institute for Research and Innovation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Prior malignancies treated primarily or for recurrence within 2 years prior to inclusion in this study, except for completely resected non-melanomatous skin carcinoma, or successfully treated in situ carcinoma of the skin, breast or cervix of the uterus
- 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
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 |
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Experimental: NovoTTF-100L(O)
Patients receive TTFields using the NovoTTF-100L(O) System together with weekly Paclitaxel
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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.
Other Names:
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.
Other Names:
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Active Comparator: Best Standard of Care
Patients receive best standard of care with weekly Paclitaxel
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 4 years
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4 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: 4 years
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4 years
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Objective response rate
Time Frame: 4 years
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4 years
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Next progression-free survival
Time Frame: 4 years
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Measured from the time of randomization to tumor progression on next-line treatment
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4 years
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Time to undisputable deterioration in health-related quality of life (HRQoL)
Time Frame: 4 years
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Measured as the time interval between randomization until the first decrease in HRQoL score ≥ 10-point with no further improvement in HRQoL score ≥ 10 points on any further HRQoL data, based on the EORTC QLQ-C30 questionnaire
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4 years
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Time to first and second subsequent treatment
Time Frame: 4 years
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Measured as the time from the date of randomization to the clinical decision made by the investigator to initiate a first and second subsequent lines of treatment, respectively, or death date
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4 years
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Quality of life using the EORTC QLQ C30 questionnaire with the ovarian cancer symptom OV28 module.
Time Frame: 4 years
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4 years
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Severity and frequency of adverse events
Time Frame: 4 years
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4 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ignace Vergote, MD, University Hospitals Leuven, Leuven Cancer Institute
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.
- Taphoorn 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.
- 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.
- Vergote 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.
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
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- EF-28
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 Ovarian Cancer
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
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Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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Eve RodlerNot yet recruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
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University of WashingtonMinnesota Ovarian Cancer AllianceTerminatedStage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage IVA Ovarian Cancer AJCC v8 | Stage IVB Ovarian... and other conditionsUnited States
Clinical Trials on NovoTTF-100L(O)
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Mayo ClinicNovoCure Ltd.RecruitingPancreatic Adenocarcinoma | Pancreas Cancer | Metastatic Pancreatic Cancer | Metastatic AdenocarcinomaUnited States
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Baptist Health South FloridaNovoCure Ltd.RecruitingPancreas Cancer | Locally Advanced Pancreatic Adenocarcinoma | Locally AdvancedUnited States
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NovoCure Ltd.UnknownOvarian CarcinomaSwitzerland, Belgium, Germany, Spain
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NovoCure GmbHUnknownHepatocellular CarcinomaItaly, Czechia, France, Germany, Poland, Spain
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NovoCure Ltd.CompletedNSCLC | Non-small Cell Lung CancerSwitzerland
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Duke UniversityNovoCure Ltd.CompletedMalignant GliomaUnited States
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NovoCure GmbHZai Lab (Shanghai) Co., Ltd.UnknownGastric Cancer | GastroEsophageal CancerHong Kong
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NovoCure Ltd.CompletedMalignant Pleural MesotheliomaNetherlands, Italy, Germany, Belgium, France, Poland, Spain
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Memorial Sloan Kettering Cancer CenterNovoCure Ltd.RecruitingAdenocarcinoma of LungUnited States