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AzTrials

Ovarian CancerPhase 3NCT03940196

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)

A Phase 3 study testing NovoTTF-100L(O) and Paclitaxel in people with Ovarian Cancer, run by NovoCure Ltd. at 119 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 . Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
NovoTTF-100L(O) and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
119 sitesin 13 countries
Study dates
22 Mar 2019to 18 May 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

119 sites in 13 countries.

119 sites in 13 countries

United States59 sites

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • University of Colorado Denver

    Aurora, Colorado, 80045-2517

  • Texas Oncology Austin-Balcones

    Austin, Texas, 78731

  • Texas Oncology Austin-Midtown

    Austin, Texas, 78745

  • Texas Oncology Austin-North Austin

    Austin, Texas, 78758

  • Rocky Mountain Cancer Centers

    Boulder, Colorado, 80303

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805

  • MD Anderson Cancer Center at Cooper

    Camden, New Jersey, 08103

  • Miami Valley Hospital South

    Centerville, Ohio, 45459-447

  • Rush University Cancer Center - Chicago and Innovation

    Chicago, Illinois, 60612-3833

  • Rocky Mountain Cancer Centers

    Colorado Springs, Colorado, 80907

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210-1240

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75216

  • Texas Oncology

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80220

  • Des Moines Oncology Research Association

    Des Moines, Iowa, 50309

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

  • Texas Oncology-Fort Worth

    Fort Worth, Texas, 76104-2150

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • The University of Texas Medical School at Houston

    Houston, Texas, 77030-1501

  • University of California

    La Jolla, California, 92093-1503

  • Rocky Mountain Cancer Centers

    Lakewood, Colorado, 80228

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89169

  • Rocky Mountain Cancer Centers

    Littleton, Colorado, 80120-4413

  • Rocky Mountain Cancer Centers

    Lone Tree, Colorado, 80124

  • Rocky Mountain Cancer Centers

    Longmont, Colorado, 80501

  • Norton Cancer Institute

    Louisville, Kentucky, 40202-2025

  • Texas Oncology-McAllen

    McAllen, Texas, 78503

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114-4108

  • AdventHealth Cancer Institute

    Orlando, Florida, 32804

  • The Valley Hospital

    Paramus, New Jersey, 07652

  • Rocky Mountain Cancer Centers

    Parker, Colorado, 80138

  • Arizona Oncology- Biltmore Cancer Center

    Phoenix, Arizona, 85016

  • West Penn OB/GYN

    Pittsburgh, Pennsylvania, 15212

  • UPMC Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Northwest Cancer Specialists, PC

    Portland, Oregon, 97227

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905-2401

  • Rocky Mountain Cancer Centers

    Pueblo, Colorado, 81008

  • Center of Hope at Renown Medical Center

    Reno, Nevada, 89502

  • Carilion Clinic-Gynecologic Oncology

    Roanoke, Virginia, 24016-4962

  • Minnesota Oncology Hematology, PA

    Saint Paul, Minnesota, 55102

  • Texas Oncology San Antonio Medical Center

    San Antonio, Texas, 78240

  • California Pacific Medical Center- Pacific Campus

    San Francisco, California, 94109

  • Maryland Oncology Hematology, P.A.

    Silver Spring, Maryland, 20902

  • Sanford Gynecologic Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110-1010

  • Texas Oncology - Sugar Land

    Sugar Land, Texas, 77479-4308

  • Olive View - UCLA Medical Center

    Sylmar, California, 91342

  • Multicare Institute for Research and Innovation

    Tacoma, Washington, 98405

  • Texas Oncology

    The Woodlands, Texas, 77380

  • Rocky Mountain Cancer Centers

    Thornton, Colorado, 80260

  • Arizona Oncology

    Tucson, Arizona, 85711

  • Texas Oncology-Tyler

    Tyler, Texas, 75702

  • Texas Oncology-Deke Slayton Cancer Center

    Webster, Texas, 77598

  • Abington Hospital- Asplundh Cancer Pavilion

    Willow Grove, Pennsylvania, 19001-3720

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

Belgium8 sites

  • Imelda Ziekenhuis Bonheiden

    Bonheiden, 2820

  • Cliniques Universitaires Saint Luc, Institut Roi Albert II

    Brussels, 1200

  • Grand Hôpital de Charleroi, Oncologie-Hématologie

    Charleroi, 6000

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

    Ghent, 9000

  • UZ Gent

    Ghent, 9000

  • University Hospitals Leuven, Leuven Cancer Institute

    Leuven

  • CHU Ambroise Paré

    Mons, 7000

  • CHU UCL Namur - Site Ste Elisabeth

    Namur, 5000

Other trials in Belgium

Italy8 sites

  • Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii

    Bologna, 40138

  • Presidio Ospedaliero Antonio Perrino - ASL Brindisi

    Brindisi, 72100

  • ASST Lecco - Ospedale Manzoni, Dipartimento Oncologico

    Lecco, 23900

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

    Milan, 20141

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

    Milan, 60 20132

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, 80130

  • Fondazione Policlinico Universitario Gemelli

    Roma, 00168

  • University Saint Anna

    Torino, 10126

Other trials in Italy

Poland7 sites

  • Szpitale Pomorskie Sp. z o.o.

    Gdynia, 81-519

  • Oddział Kliniczny Chirurgii Ogólnej i Onkologicznej, Szpital Św. Rafała

    Krakow, 30-693

  • Uniwersytet Medyczny w Lublinie, I Klinika Ginekologii Onkologicznej i Ginekologii

    Lublin, 20-081

  • 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

  • Oddział Ginekologii Onkologicznej Katedry i Kliniki Onkologii Uniwersytetu Medycznego w Poznaniu

    Poznan, 60-569

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

    Szczecin, 70-111

  • Szpital Kliniczny im. ks. Anny Mazowieckiej

    Warsaw, 00-315

Other trials in Poland

Spain7 sites

  • Servicio de Oncología Médica, Hospital Universitario Quirón Dexeus

    Barcelona, 08028

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

    Girona, 17007

  • Clinica Universidad de Navarra en Madrid

    Madrid, 28027

  • Hospital MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Universitario Ramon y Cajal, Servicio de Oncologia Médica

    Madrid, 28034

  • Hospital 12 de Octubre. Servicio Oncología Médica

    Madrid, 28041

  • Fundació Institut d'Investigació Sanitària Illes Balears - IdISBa, Hospital Universitari Son Espases

    Palma de Mallorca, 07120

Other trials in Spain

Canada5 sites

  • Tom Baker Cancer Center

    Calgary, H2L 4M1

  • Centre Hospitalie

    Montreal, Quebec, H2X 0A9

  • McGill University Health Centre

    Montreal, H4A 3J1

  • Jewish General Hospital

    Montreal, QC H3T 1E2

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E)V9

Other trials in Canada

Czechia5 sites

  • Gynekologicko-porodnické oddělení - Nemocnice České Budějovice a.s.

    České Budějovice, 370 01

  • Onkologická Klinika Fakultní nemocnice Olomouc

    Olomouc, 779 00

  • University Hospital Ostrava

    Ostrava-Poruba, 708 52

  • Gynekologicko-porodnická klinika, Fakultní nemocnice Královské Vinohrady

    Prague, 100 34

  • Gynekologicko-porodnická klinika 1. LF UK a VFN

    Prague, 128 01

Other trials in Czechia

Austria4 sites

  • KH der Barmherzigen Brüder Graz

    Graz, 8020

  • Univ.-Klinik für Gynäkologie und Geburtshilfe

    Graz, 8036

  • Univ.-Klinik für Gynäkologie und Geburtshilfe, Innsbruck

    Innsbruck

  • Landesfrauenklinik Salzburg

    Salzburg, 5020

Other trials in Austria

Israel4 sites

  • Hillel Yaffe Medical Center

    Hadera, 38100

  • Saare Zedek Medical Center - Gyneco-Oncology

    Jerusalem, 9103102

  • Oncology Institute, Galilee Medical Center

    Nahariya, 22100

  • Gyneco-Oncology Chaim Sheba Medical Center

    Ramat Gan, 5265601

Other trials in Israel

Switzerland4 sites

  • Gynecological Tumor Center, University Hospital Basel

    Basel, 4031

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

    Bellinzona, 6500

  • Kantonsspital Frauenfeld - Frauenklinik

    Frauenfeld, 8501

  • UniversitätsSpital Zürich - Klinik für Gynäkologie

    Zurich, 8091

Other trials in Switzerland

Germany3 sites

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

    Berlin, 1200

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 01307

  • Horst-Schmidt-Kliniken, Gynecology and Gynecologic, Oncology Department

    Wiesbaden, 65199

Other trials in Germany

Hungary3 sites

  • Semmelweis University

    Budapest, 1085

  • Nőgyógyászati Osztály, Országos Onkológiai Intézet

    Budapest, 1122

  • Szuleszeti és Nogyogyaszati Klinika

    Debrecen, 4032

Other trials in Hungary

Netherlands2 sites

  • Amsterdam Universitair Medische centra

    Amsterdam, 1105

  • University Medical Center Utrech

    Utrecht, 3508

Other trials in Netherlands

About this study

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

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.

Read the 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.

Conditions
Ovarian Cancer
Being tested
NovoTTF-100L(O), Paclitaxel
Keywords
Platinum Resistant Ovarian Cancer, TTFields, Paclitaxel, Minimal toxicity, TTF, Tumor Treating Fields, Novocure
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NovoTTF-100L(O)Device

    Also called TTFields

    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.

  • PaclitaxelDrug

    Also called Weekly Paclitaxel, Taxol

    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.

Study groups in NCT03940196
Study groupRoleWhat they receive
NovoTTF-100L(O)ExperimentalPatients receive TTFields using the NovoTTF-100L(O) System together with weekly Paclitaxel
Receives: Device: NovoTTF-100L(O); Drug: Paclitaxel
Best Standard of CareActive comparatorPatients receive best standard of care with weekly Paclitaxel
Receives: Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: 4 years

Secondary outcomes (7)

  1. Progression-free survival

    Measured: 4 years

  2. Objective response rate

    Measured: 4 years

  3. Next progression-free survival

    Measured from the time of randomization to tumor progression on next-line treatment

    Measured: 4 years

  4. Time to undisputable deterioration in health-related quality of life (HRQoL)

    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

    Measured: 4 years

  5. Time to first and second subsequent treatment

    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

    Measured: 4 years

  6. Quality of life using the EORTC QLQ C30 questionnaire with the ovarian cancer symptom OV28 module.

    Measured: 4 years

  7. Severity and frequency of adverse events

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2019
  2. Study start22 Mar 2019
  3. Primary completion18 May 2023
  4. Study completion18 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
540 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03940196
Sponsor's protocol ID
EF-28
Status last verified
Mar 2024
First submitted
29 Apr 2019
Last updated
29 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 15126372

  • 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.

    PubMed 17551011

  • 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.

    PubMed 22608262

  • 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.

    PubMed 19387848

  • 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.

    PubMed 26658786

  • 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.

    PubMed 26670971

  • 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.

    PubMed 29260225

  • 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.

    PubMed 30060963

  • 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.

    PubMed 29392280

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NovoTTF-100L(O) and Paclitaxel in people with Ovarian Cancer, run by NovoCure Ltd. at 119 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in United States, Belgium, Italy, Poland, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03940196, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.

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