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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)

Primary Purpose

Ovarian Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NovoTTF-100L(O)
Paclitaxel
Sponsored by
NovoCure Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Platinum Resistant Ovarian Cancer, TTFields, Paclitaxel, Minimal toxicity, TTF, Tumor Treating Fields, Novocure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years of age and older
  2. Epithelial histology of ovarian/primary peritoneal or fallopian tube carcinoma at the time of diagnosis
  3. Life expectancy of ≥ 12 weeks
  4. Maximum two prior lines of systemic therapy following diagnosis of platinum-resistance
  5. Maximum total of 5 prior lines of systemic therapy
  6. Amenable to receive weekly paclitaxel and able to operate the NovoTTF-100L(O) System
  7. ECOG 0-1
  8. Evaluable (measurable or non-measurable) disease in the abdominal/pelvic region per RECIST V1.
  9. Signed informed consent form for the study protocol

Exclusion Criteria:

  1. 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
  2. Prior disease progression on a weekly paclitaxel for recurrent disease
  3. Brain metastasis or leptomeningeal spread of the tumor
  4. Albumin level <25 gram/liter (subjects should not receive total parenteral nutrition or albumin within 2 weeks of the test)
  5. CTCAE V5.0 Grade 3 or higher peripheral neuropathy
  6. Implantable electrical medical devices
  7. Known allergies to medical adhesives or hydrogel
  8. 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
  9. 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
  10. Serious co-morbidities
  11. Concurrent anti-tumor therapy beyond weekly paclitaxel, excluding hormonal therapy for breast cancer
  12. Concurrent active treatment in another clinical trial. However prior participation in clinical trials is allowed as well as participation during survival follow-up
  13. 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
  14. Admitted to an institution by administrative or court order

Sites / Locations

  • Arizona Oncology- Biltmore Cancer Center
  • Arizona Oncology
  • University of California
  • Hoag Memorial Hospital Presbyterian
  • California Pacific Medical Center- Pacific Campus
  • Olive View - UCLA Medical Center
  • Rocky Mountain Cancer Centers
  • University of Colorado Denver
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Broward Health Medical Center
  • AdventHealth Cancer Institute
  • Northeast Georgia Medical Center
  • Rush University Cancer Center - Chicago and Innovation
  • Des Moines Oncology Research Association
  • Norton Cancer Institute
  • Maryland Oncology Hematology, P.A.
  • Lahey Hospital & Medical Center
  • Minnesota Oncology Hematology, PA
  • Washington University School of Medicine in St. Louis
  • Methodist Estabrook Cancer Center
  • Women's Cancer Center of Nevada
  • Center of Hope at Renown Medical Center
  • MD Anderson Cancer Center at Cooper
  • The Valley Hospital
  • Wake Forest Baptist Medical Center
  • Miami Valley Hospital South
  • The Ohio State University Wexner Medical Center
  • Northwest Cancer Specialists, PC
  • West Penn OB/GYN
  • UPMC Cancer Center
  • Abington Hospital- Asplundh Cancer Pavilion
  • Women & Infants Hospital of Rhode Island
  • Sanford Gynecologic Oncology Clinic
  • Texas Oncology Austin-Balcones
  • Texas Oncology Austin-Midtown
  • Texas Oncology Austin-North Austin
  • University of Texas Southwestern Medical Center
  • Texas Oncology
  • Texas Oncology-Fort Worth
  • The University of Texas Medical School at Houston
  • Texas Oncology-McAllen
  • Texas Oncology San Antonio Medical Center
  • Texas Oncology - Sugar Land
  • Texas Oncology
  • Texas Oncology-Tyler
  • Texas Oncology-Deke Slayton Cancer Center
  • Virginia Oncology Associates
  • Carilion Clinic-Gynecologic Oncology
  • Multicare Institute for Research and Innovation
  • KH der Barmherzigen Brüder Graz
  • Univ.-Klinik für Gynäkologie und Geburtshilfe
  • Univ.-Klinik für Gynäkologie und Geburtshilfe, Innsbruck
  • Landesfrauenklinik Salzburg
  • Imelda Ziekenhuis Bonheiden
  • Cliniques Universitaires Saint Luc, Institut Roi Albert II
  • Grand Hôpital de Charleroi, Oncologie-Hématologie
  • AZ Maria Middelares, Clinical Trial Unit Medical Oncology - Integrated Cancer Center Ghent
  • UZ Gent
  • University Hospitals Leuven, Leuven Cancer Institute
  • CHU Ambroise Paré
  • CHU UCL Namur - Site Ste Elisabeth
  • CancerCare Manitoba
  • Centre Hospitalie
  • Tom Baker Cancer Center
  • McGill University Health Centre
  • Jewish General Hospital
  • Onkologická Klinika Fakultní nemocnice Olomouc
  • University Hospital Ostrava
  • Gynekologicko-porodnická klinika, Fakultní nemocnice Královské Vinohrady
  • Gynekologicko-porodnická klinika 1. LF UK a VFN
  • Gynekologicko-porodnické oddělení - Nemocnice České Budějovice a.s.
  • Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Gynäkologie
  • Universitätsklinikum Carl Gustav Carus
  • Horst-Schmidt-Kliniken, Gynecology and Gynecologic, Oncology Department
  • Semmelweis University
  • Nőgyógyászati Osztály, Országos Onkológiai Intézet
  • Szuleszeti és Nogyogyaszati Klinika
  • Hillel Yaffe Medical Center
  • Saare Zedek Medical Center - Gyneco-Oncology
  • Oncology Institute, Galilee Medical Center
  • Gyneco-Oncology Chaim Sheba Medical Center
  • Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii
  • Presidio Ospedaliero Antonio Perrino - ASL Brindisi
  • ASST Lecco - Ospedale Manzoni, Dipartimento Oncologico
  • Dipartimento Medicina e Chirurgia, Università Milano-Bicocca, Direttore Programma Ginecologia Oncologica, Istituto Europeo Oncologia
  • IRCCS Ospedale San Raffaele, U.O. Ginecologia-Ematologia e TMO
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale
  • Fondazione Policlinico Universitario Gemelli
  • University Saint Anna
  • Amsterdam Universitair Medische centra
  • University Medical Center Utrech
  • Szpitale Pomorskie Sp. z o.o.
  • Oddział Kliniczny Chirurgii Ogólnej i Onkologicznej, Szpital Św. Rafała
  • Uniwersytet Medyczny w Lublinie, I Klinika Ginekologii Onkologicznej i Ginekologii
  • Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie, Oddział Kliniczny Onkologii i Immunoonkologii z Ośrodkiem Dziennym Terapii Onkologicznej
  • Oddział Ginekologii Onkologicznej Katedry i Kliniki Onkologii Uniwersytetu Medycznego w Poznaniu
  • Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie, Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt
  • Szpital Kliniczny im. ks. Anny Mazowieckiej
  • Servicio de Oncología Médica, Hospital Universitario Quirón Dexeus
  • lnstitut Catala d'Oncologia, Hospital Universitario Dr. Josep Trueta, Servicio de Oncologia,
  • Clinica Universidad de Navarra en Madrid
  • Hospital MD Anderson Cancer Center
  • Hospital Universitario Ramon y Cajal, Servicio de Oncologia Médica
  • Hospital 12 de Octubre. Servicio Oncología Médica
  • Fundació Institut d'Investigació Sanitària Illes Balears - IdISBa, Hospital Universitari Son Espases
  • Gynecological Tumor Center, University Hospital Basel
  • IOSI Bellinzona, Oncology Institute of Southern Switzerland, Ospedale San Giovanni
  • Kantonsspital Frauenfeld - Frauenklinik
  • UniversitätsSpital Zürich - Klinik für Gynäkologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NovoTTF-100L(O)

Best Standard of Care

Arm Description

Patients receive TTFields using the NovoTTF-100L(O) System together with weekly Paclitaxel

Patients receive best standard of care with weekly Paclitaxel

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Progression-free survival
Objective response rate
Next progression-free survival
Measured from the time of randomization to tumor progression on next-line treatment
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
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
Quality of life using the EORTC QLQ C30 questionnaire with the ovarian cancer symptom OV28 module.
Severity and frequency of adverse events

Full Information

First Posted
April 29, 2019
Last Updated
April 19, 2022
Sponsor
NovoCure Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03940196
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 Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 22, 2019 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NovoCure Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Platinum Resistant Ovarian Cancer, TTFields, Paclitaxel, Minimal toxicity, TTF, Tumor Treating Fields, Novocure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
540 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NovoTTF-100L(O)
Arm Type
Experimental
Arm Description
Patients receive TTFields using the NovoTTF-100L(O) System together with weekly Paclitaxel
Arm Title
Best Standard of Care
Arm Type
Active Comparator
Arm Description
Patients receive best standard of care with weekly Paclitaxel
Intervention Type
Device
Intervention Name(s)
NovoTTF-100L(O)
Other Intervention Name(s)
TTFields
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Weekly Paclitaxel, Taxol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
4 years
Title
Objective response rate
Time Frame
4 years
Title
Next progression-free survival
Description
Measured from the time of randomization to tumor progression on next-line treatment
Time Frame
4 years
Title
Time to undisputable deterioration in health-related quality of life (HRQoL)
Description
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
Time Frame
4 years
Title
Time to first and second subsequent treatment
Description
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
Time Frame
4 years
Title
Quality of life using the EORTC QLQ C30 questionnaire with the ovarian cancer symptom OV28 module.
Time Frame
4 years
Title
Severity and frequency of adverse events
Time Frame
4 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ignace Vergote, MD
Organizational Affiliation
University Hospitals Leuven, Leuven Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Oncology- Biltmore Cancer Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Arizona Oncology
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
University of California
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-1503
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
California Pacific Medical Center- Pacific Campus
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Olive View - UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-2517
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120-4413
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Parker
State/Province
Colorado
ZIP/Postal Code
80138
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81008
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80260
Country
United States
Facility Name
Broward Health Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
AdventHealth Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Rush University Cancer Center - Chicago and Innovation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3833
Country
United States
Facility Name
Des Moines Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-2025
Country
United States
Facility Name
Maryland Oncology Hematology, P.A.
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Lahey Hospital & Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Minnesota Oncology Hematology, PA
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Washington University School of Medicine in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1010
Country
United States
Facility Name
Methodist Estabrook Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114-4108
Country
United States
Facility Name
Women's Cancer Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Center of Hope at Renown Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
MD Anderson Cancer Center at Cooper
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
The Valley Hospital
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Miami Valley Hospital South
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459-447
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Northwest Cancer Specialists, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
West Penn OB/GYN
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
UPMC Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Abington Hospital- Asplundh Cancer Pavilion
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19001-3720
Country
United States
Facility Name
Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905-2401
Country
United States
Facility Name
Sanford Gynecologic Oncology Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Texas Oncology Austin-Balcones
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Oncology Austin-Midtown
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Texas Oncology Austin-North Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Texas Oncology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology-Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104-2150
Country
United States
Facility Name
The University of Texas Medical School at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-1501
Country
United States
Facility Name
Texas Oncology-McAllen
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Texas Oncology San Antonio Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Texas Oncology - Sugar Land
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479-4308
Country
United States
Facility Name
Texas Oncology
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Texas Oncology-Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Texas Oncology-Deke Slayton Cancer Center
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Carilion Clinic-Gynecologic Oncology
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016-4962
Country
United States
Facility Name
Multicare Institute for Research and Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
KH der Barmherzigen Brüder Graz
City
Graz
ZIP/Postal Code
8020
Country
Austria
Facility Name
Univ.-Klinik für Gynäkologie und Geburtshilfe
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Univ.-Klinik für Gynäkologie und Geburtshilfe, Innsbruck
City
Innsbruck
Country
Austria
Facility Name
Landesfrauenklinik Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Imelda Ziekenhuis Bonheiden
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Cliniques Universitaires Saint Luc, Institut Roi Albert II
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Grand Hôpital de Charleroi, Oncologie-Hématologie
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
AZ Maria Middelares, Clinical Trial Unit Medical Oncology - Integrated Cancer Center Ghent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
University Hospitals Leuven, Leuven Cancer Institute
City
Leuven
Country
Belgium
Facility Name
CHU Ambroise Paré
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
CHU UCL Namur - Site Ste Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E)V9
Country
Canada
Facility Name
Centre Hospitalie
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Tom Baker Cancer Center
City
Calgary
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
McGill University Health Centre
City
Montréal
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Jewish General Hospital
City
Montréal
ZIP/Postal Code
QC H3T 1E2
Country
Canada
Facility Name
Onkologická Klinika Fakultní nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
University Hospital Ostrava
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Gynekologicko-porodnická klinika, Fakultní nemocnice Královské Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Gynekologicko-porodnická klinika 1. LF UK a VFN
City
Praha 2
ZIP/Postal Code
128 01
Country
Czechia
Facility Name
Gynekologicko-porodnické oddělení - Nemocnice České Budějovice a.s.
City
České Budějovice
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Gynäkologie
City
Berlin
ZIP/Postal Code
1200
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Horst-Schmidt-Kliniken, Gynecology and Gynecologic, Oncology Department
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Nőgyógyászati Osztály, Országos Onkológiai Intézet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Szuleszeti és Nogyogyaszati Klinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
Saare Zedek Medical Center - Gyneco-Oncology
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Oncology Institute, Galilee Medical Center
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Gyneco-Oncology Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Presidio Ospedaliero Antonio Perrino - ASL Brindisi
City
Brindisi
ZIP/Postal Code
72100
Country
Italy
Facility Name
ASST Lecco - Ospedale Manzoni, Dipartimento Oncologico
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Dipartimento Medicina e Chirurgia, Università Milano-Bicocca, Direttore Programma Ginecologia Oncologica, Istituto Europeo Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele, U.O. Ginecologia-Ematologia e TMO
City
Milano
ZIP/Postal Code
60 20132
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale
City
Napoli
ZIP/Postal Code
80130
Country
Italy
Facility Name
Fondazione Policlinico Universitario Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
University Saint Anna
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Amsterdam Universitair Medische centra
City
Amsterdam
ZIP/Postal Code
1105
Country
Netherlands
Facility Name
University Medical Center Utrech
City
Utrecht
ZIP/Postal Code
3508
Country
Netherlands
Facility Name
Szpitale Pomorskie Sp. z o.o.
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Oddział Kliniczny Chirurgii Ogólnej i Onkologicznej, Szpital Św. Rafała
City
Kraków
ZIP/Postal Code
30-693
Country
Poland
Facility Name
Uniwersytet Medyczny w Lublinie, I Klinika Ginekologii Onkologicznej i Ginekologii
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie, Oddział Kliniczny Onkologii i Immunoonkologii z Ośrodkiem Dziennym Terapii Onkologicznej
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Oddział Ginekologii Onkologicznej Katedry i Kliniki Onkologii Uniwersytetu Medycznego w Poznaniu
City
Poznań
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie, Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Szpital Kliniczny im. ks. Anny Mazowieckiej
City
Warsaw
ZIP/Postal Code
00-315
Country
Poland
Facility Name
Servicio de Oncología Médica, Hospital Universitario Quirón Dexeus
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
lnstitut Catala d'Oncologia, Hospital Universitario Dr. Josep Trueta, Servicio de Oncologia,
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Clinica Universidad de Navarra en Madrid
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Hospital MD Anderson Cancer Center
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal, Servicio de Oncologia Médica
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital 12 de Octubre. Servicio Oncología Médica
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Fundació Institut d'Investigació Sanitària Illes Balears - IdISBa, Hospital Universitari Son Espases
City
Palma De Mallorca
ZIP/Postal Code
07120
Country
Spain
Facility Name
Gynecological Tumor Center, University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
IOSI Bellinzona, Oncology Institute of Southern Switzerland, Ospedale San Giovanni
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Kantonsspital Frauenfeld - Frauenklinik
City
Frauenfeld
ZIP/Postal Code
8501
Country
Switzerland
Facility Name
UniversitätsSpital Zürich - Klinik für Gynäkologie
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
15126372
Citation
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.
Results Reference
background
PubMed Identifier
17551011
Citation
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.
Results Reference
background
PubMed Identifier
22608262
Citation
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.
Results Reference
background
PubMed Identifier
19387848
Citation
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.
Results Reference
background
PubMed Identifier
26658786
Citation
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.
Results Reference
background
PubMed Identifier
26670971
Citation
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.
Results Reference
background
PubMed Identifier
29260225
Citation
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.
Results Reference
background
PubMed Identifier
30060963
Citation
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.
Results Reference
background
PubMed Identifier
29392280
Citation
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.
Results Reference
background

Learn more about this trial

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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