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Spots Global Cancer Trial Database for 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)

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Trial Identification

Brief Title: 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)

Official Title: 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 ID: NCT03940196

Conditions

Ovarian Cancer

Study Description

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.

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: 1. Patients receive TTFields at 200 kHz to the abdomen and pelvis using the NovoTTF-100L(O) System together with weekly paclitaxel. 2. 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Arizona Oncology- Biltmore Cancer Center, Phoenix, Arizona, United States

Arizona Oncology, Tucson, Arizona, United States

University of California, La Jolla, California, United States

Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States

California Pacific Medical Center- Pacific Campus, San Francisco, California, United States

Olive View - UCLA Medical Center, Sylmar, California, United States

Rocky Mountain Cancer Centers, Aurora, Colorado, United States

University of Colorado Denver, Aurora, Colorado, United States

Rocky Mountain Cancer Centers, Boulder, Colorado, United States

Rocky Mountain Cancer Centers, Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers, Denver, Colorado, United States

Rocky Mountain Cancer Centers, Denver, Colorado, United States

Rocky Mountain Cancer Centers, Lakewood, Colorado, United States

Rocky Mountain Cancer Centers, Littleton, Colorado, United States

Rocky Mountain Cancer Centers, Lone Tree, Colorado, United States

Rocky Mountain Cancer Centers, Longmont, Colorado, United States

Rocky Mountain Cancer Centers, Parker, Colorado, United States

Rocky Mountain Cancer Centers, Pueblo, Colorado, United States

Rocky Mountain Cancer Centers, Thornton, Colorado, United States

Broward Health Medical Center, Fort Lauderdale, Florida, United States

AdventHealth Cancer Institute, Orlando, Florida, United States

Northeast Georgia Medical Center, Gainesville, Georgia, United States

Rush University Cancer Center - Chicago and Innovation, Chicago, Illinois, United States

Des Moines Oncology Research Association, Des Moines, Iowa, United States

Norton Cancer Institute, Louisville, Kentucky, United States

Maryland Oncology Hematology, P.A., Silver Spring, Maryland, United States

Lahey Hospital & Medical Center, Burlington, Massachusetts, United States

Minnesota Oncology Hematology, PA, Saint Paul, Minnesota, United States

Washington University School of Medicine in St. Louis, Saint Louis, Missouri, United States

Methodist Estabrook Cancer Center, Omaha, Nebraska, United States

Women's Cancer Center of Nevada, Las Vegas, Nevada, United States

Center of Hope at Renown Medical Center, Reno, Nevada, United States

MD Anderson Cancer Center at Cooper, Camden, New Jersey, United States

The Valley Hospital, Paramus, New Jersey, United States

Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States

Miami Valley Hospital South, Centerville, Ohio, United States

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States

Northwest Cancer Specialists, PC, Portland, Oregon, United States

West Penn OB/GYN, Pittsburgh, Pennsylvania, United States

UPMC Cancer Center, Pittsburgh, Pennsylvania, United States

Abington Hospital- Asplundh Cancer Pavilion, Willow Grove, Pennsylvania, United States

Women & Infants Hospital of Rhode Island, Providence, Rhode Island, United States

Sanford Gynecologic Oncology Clinic, Sioux Falls, South Dakota, United States

Texas Oncology Austin-Balcones, Austin, Texas, United States

Texas Oncology Austin-Midtown, Austin, Texas, United States

Texas Oncology Austin-North Austin, Austin, Texas, United States

University of Texas Southwestern Medical Center, Dallas, Texas, United States

Texas Oncology, Dallas, Texas, United States

Texas Oncology-Fort Worth, Fort Worth, Texas, United States

The University of Texas Medical School at Houston, Houston, Texas, United States

Texas Oncology-McAllen, McAllen, Texas, United States

Texas Oncology San Antonio Medical Center, San Antonio, Texas, United States

Texas Oncology - Sugar Land, Sugar Land, Texas, United States

Texas Oncology, The Woodlands, Texas, United States

Texas Oncology-Tyler, Tyler, Texas, United States

Texas Oncology-Deke Slayton Cancer Center, Webster, Texas, United States

Virginia Oncology Associates, Norfolk, Virginia, United States

Carilion Clinic-Gynecologic Oncology, Roanoke, Virginia, United States

Multicare Institute for Research and Innovation, Tacoma, Washington, United States

KH der Barmherzigen Brüder Graz, Graz, , Austria

Univ.-Klinik für Gynäkologie und Geburtshilfe, Graz, , Austria

Univ.-Klinik für Gynäkologie und Geburtshilfe, Innsbruck, Innsbruck, , Austria

Landesfrauenklinik Salzburg, Salzburg, , Austria

Imelda Ziekenhuis Bonheiden, Bonheiden, , Belgium

Cliniques Universitaires Saint Luc, Institut Roi Albert II, Brussel, , Belgium

Grand Hôpital de Charleroi, Oncologie-Hématologie, Charleroi, , Belgium

AZ Maria Middelares, Clinical Trial Unit Medical Oncology - Integrated Cancer Center Ghent, Gent, , Belgium

UZ Gent, Gent, , Belgium

University Hospitals Leuven, Leuven Cancer Institute, Leuven, , Belgium

CHU Ambroise Paré, Mons, , Belgium

CHU UCL Namur - Site Ste Elisabeth, Namur, , Belgium

CancerCare Manitoba, Winnipeg, Manitoba, Canada

Centre Hospitalie, Montréal, Quebec, Canada

Tom Baker Cancer Center, Calgary, , Canada

McGill University Health Centre, Montréal, , Canada

Jewish General Hospital, Montréal, , Canada

Onkologická Klinika Fakultní nemocnice Olomouc, Olomouc, , Czechia

University Hospital Ostrava, Ostrava-Poruba, , Czechia

Gynekologicko-porodnická klinika, Fakultní nemocnice Královské Vinohrady, Praha 10, , Czechia

Gynekologicko-porodnická klinika 1. LF UK a VFN, Praha 2, , Czechia

Gynekologicko-porodnické oddělení - Nemocnice České Budějovice a.s., České Budějovice, , Czechia

Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Gynäkologie, Berlin, , Germany

Universitätsklinikum Carl Gustav Carus, Dresden, , Germany

Horst-Schmidt-Kliniken, Gynecology and Gynecologic, Oncology Department, Wiesbaden, , Germany

Semmelweis University, Budapest, , Hungary

Nőgyógyászati Osztály, Országos Onkológiai Intézet, Budapest, , Hungary

Szuleszeti és Nogyogyaszati Klinika, Debrecen, , Hungary

Hillel Yaffe Medical Center, Hadera, , Israel

Saare Zedek Medical Center - Gyneco-Oncology, Jerusalem, , Israel

Oncology Institute, Galilee Medical Center, Nahariya, , Israel

Gyneco-Oncology Chaim Sheba Medical Center, Ramat Gan, , Israel

Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii, Bologna, , Italy

Presidio Ospedaliero Antonio Perrino - ASL Brindisi, Brindisi, , Italy

ASST Lecco - Ospedale Manzoni, Dipartimento Oncologico, Lecco, , Italy

Dipartimento Medicina e Chirurgia, Università Milano-Bicocca, Direttore Programma Ginecologia Oncologica, Istituto Europeo Oncologia, Milano, , Italy

IRCCS Ospedale San Raffaele, U.O. Ginecologia-Ematologia e TMO, Milano, , Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, , Italy

Fondazione Policlinico Universitario Gemelli, Roma, , Italy

University Saint Anna, Torino, , Italy

Amsterdam Universitair Medische centra, Amsterdam, , Netherlands

University Medical Center Utrech, Utrecht, , Netherlands

Szpitale Pomorskie Sp. z o.o., Gdynia, , Poland

Oddział Kliniczny Chirurgii Ogólnej i Onkologicznej, Szpital Św. Rafała, Kraków, , Poland

Uniwersytet Medyczny w Lublinie, I Klinika Ginekologii Onkologicznej i Ginekologii, Lublin, , 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, , Poland

Oddział Ginekologii Onkologicznej Katedry i Kliniki Onkologii Uniwersytetu Medycznego w Poznaniu, Poznań, , Poland

Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie, Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt, Szczecin, , Poland

Szpital Kliniczny im. ks. Anny Mazowieckiej, Warsaw, , Poland

Servicio de Oncología Médica, Hospital Universitario Quirón Dexeus, Barcelona, , Spain

lnstitut Catala d'Oncologia, Hospital Universitario Dr. Josep Trueta, Servicio de Oncologia,, Girona, , Spain

Clinica Universidad de Navarra en Madrid, Madrid, , Spain

Hospital MD Anderson Cancer Center, Madrid, , Spain

Hospital Universitario Ramon y Cajal, Servicio de Oncologia Médica, Madrid, , Spain

Hospital 12 de Octubre. Servicio Oncología Médica, Madrid, , Spain

Fundació Institut d'Investigació Sanitària Illes Balears - IdISBa, Hospital Universitari Son Espases, Palma De Mallorca, , Spain

Gynecological Tumor Center, University Hospital Basel, Basel, , Switzerland

IOSI Bellinzona, Oncology Institute of Southern Switzerland, Ospedale San Giovanni, Bellinzona, , Switzerland

Kantonsspital Frauenfeld - Frauenklinik, Frauenfeld, , Switzerland

UniversitätsSpital Zürich - Klinik für Gynäkologie, Zürich, , Switzerland

Contact Details

Name: Ignace Vergote, MD

Affiliation: University Hospitals Leuven, Leuven Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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