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Trial record 36 of 603 for:    Recruiting, Not yet recruiting, Available Studies | Ovarian cancer

Effect of Tumor Treating Fields (TTFields, 200 kHz) Concomitant With Weekly Paclitaxel for the Treatment of Platinum-resistant Ovarian Cancer (PROC) (ENGOT-ov50 / GOG-3029 / INNOVATE-3)

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ClinicalTrials.gov Identifier: NCT03940196
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd.

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 platinum-resistant ovarian cancer (PROC). 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Device: NovoTTF-100L(O) Drug: Paclitaxel Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Platinum-resistant Ovarian Cancer (PROC)
Actual Study Start Date : March 22, 2019
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024


Arm Intervention/treatment
Experimental: NovoTTF-100L(O)
Patients receive TTFields using the NovoTTF-100L(O) System together with weekly Paclitaxel
Device: NovoTTF-100L(O)
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 Name: TTFields

Drug: Paclitaxel
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:
  • Weekly Paclitaxel
  • Taxol

Active Comparator: Best Standard of Care
Patients receive best standard of care with weekly Paclitaxel
Drug: Paclitaxel
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:
  • Weekly Paclitaxel
  • Taxol




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 4 years ]
  2. Objective response rate [ Time Frame: 4 years ]
  3. Next progression-free survival [ Time Frame: 4 years ]
    Measured from the time of randomization to tumor progression on next-line treatment

  4. Time to undisputable deterioration in health-related quality of life (HRQoL) [ Time Frame: 4 years ]
    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

  5. Time to first and second subsequent treatment [ Time Frame: 4 years ]
    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

  6. Quality of life using the EORTC QLQ C30 questionnaire with the ovarian cancer symptom OV28 module. [ Time Frame: 4 years ]
  7. Severity and frequency of adverse events [ Time Frame: 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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. Eastern Cooperative Oncology Group (ECOG) score 0-1
  8. Prior clinical trials are allowed
  9. Evaluable (measurable or non-measurable) disease in the abdominal/pelvic region per RECIST V1.1
  10. 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)
  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
  5. CTCAE V5.0 Grade 3 or higher peripheral neuropathy
  6. Implantable electronic medical devices in the torso
  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
  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 or cervix of the uterus
  10. Serious co-morbidities
  11. Concurrent anti-tumor therapy beyond weekly paclitaxel
  12. Pregnancy or breast-feeding
  13. Admitted to an institution by administrative or court order

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940196


Contacts
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Contact: Antonia Mahnig clinicaltrials@novocure.com

Locations
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Austria
KH der Barmherzigen Brüder Graz Recruiting
Graz, Austria, 8020
Contact: Christian Schauer, Dr.    +43 (0)316 / 7067 - 13102    christian.schauer@bbgraz.at   
Principal Investigator: Christian Schauer, Dr.         
Univ.-Klinik für Gynäkologie und Geburtshilfe Recruiting
Graz, Austria, 8036
Contact: Edgar Petru, Prof. Dr.    +43 (0) 316 385 81648    Edgar.petru@medunigraz.at   
Principal Investigator: Edgar Petru, Prof. Dr.         
Univ.-Klinik für Gynäkologie und Geburtshilfe, Innsbruck Recruiting
Innsbruck, Austria
Contact: Christian Marth, MD    +43 50 504 2305    Christian.marth@i-med.ac.at   
Principal Investigator: Christian Marth, MD         
Belgium
UZ Gent Recruiting
Gent, Belgium, 9000
Contact: Hannelore Denys, Dr.    +32 9 32 26 92    hannelore.denys@uzgent.be   
Principal Investigator: Hannelore Denys, Dr.         
University Hospitals Leuven, Leuven Cancer Institute Recruiting
Leuven, Belgium
Contact: Joke de Roover       joke.deroover@uzleuven.be   
Principal Investigator: Ignace Vergote, MD         
CHU UCL Namur - Site Ste Elisabeth Recruiting
Namur, Belgium, 5000
Contact: Peter Vuylsteke, Dr.    +32 81 72 07 73    peter.vuylsteke@uclouvain.be   
Principal Investigator: Peter Vuylsteke, Dr.         
Czechia
Onkologická Klinika Fakultní nemocnice Olomouc Recruiting
Olomouc, Czechia, 779 00
Contact: Bohuslav Melichar, Prof. MUDr.    +420 588 444 522    bohuslav.melichar@fnol.cz   
Principal Investigator: Bohuslav Melichar, Prof. MUDr.         
University Hospital Ostrava Recruiting
Ostrava-Poruba, Czechia, 708 52
Contact: Jaroslav Klat, Dr.    +42 059 737 18 02    Jaroslav.klat@fno.cz   
Principal Investigator: Jaroslav Klat, Dr.         
Gynekologicko-porodnická klinika 1. LF UK a VFN Recruiting
Praha 2, Czechia, 128 01
Contact: David Cibula, Prof. MUDr.    +420 224 967 451    dc@davidcibula.cz   
Principal Investigator: David Cibula, Prof. MUDr.         
Israel
Hillel Yaffe Medical Center Recruiting
Hadera, Israel, 38100
Contact: Ilan Bruchim, Dr.    +972-4-6304995    ilan.bruchim@gmail.com   
Principal Investigator: Ilan Bruchim, Dr.         
Saare Zedek Medical Center - Gyneco-Oncology Recruiting
Jerusalem, Israel, 9103102
Contact: Ora Solange Rosengarten, Dr.    +972-50-8685884    rosengarten@szmc.org.il   
Principal Investigator: Ora Solange Rosengarten, Dr.         
Oncology Institute, Galilee Medical Center Recruiting
Nahariya, Israel, 22100
Contact: Ayelet Shai, MD    + 972-4-9107422    ayelets@gmc.gov.il   
Principal Investigator: Ayelet Shai, MD         
Gyneco-Oncology Chaim Sheba Medical Center Recruiting
Ramat Gan, Israel, 5265601
Contact: Jacob Korach, MD    +972-50-7649502    jacob.korach@sheba.health.gov.il   
Principal Investigator: Jacob Korach, MD         
Italy
Presidio Ospedaliero Antonio Perrino - ASL Brindisi Recruiting
Brindisi, Italy, 72100
Contact: Saverio Cinieri, Prof.    +39 (0) 831537219    saverio.cinieri@asl.brindisi.it   
Principal Investigator: Saverio Cinieri, Prof.         
Istituto Nazionale Tumori IRCCS Fondazione Pascale Recruiting
Napoli, Italy, 80130
Contact: Sandro Pignata, Dr.    +39 081 5903637    s.pignata@istitutotumori.na.it   
Principal Investigator: Sandro Pignata, Dr.         
Switzerland
Gynecological Tumor Center, University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Viola Heinzelmann-Schwarz, Prof.    +41 61 556 58 83    viola.heinzelmann@usb.ch   
Principal Investigator: Viola Heinzelmann-Schwarz, Prof.         
Kantonsspital Frauenfeld - Frauenklinik Recruiting
Frauenfeld, Switzerland, 8501
Contact: Mathias Fehr, Prof. Dr.    +41 52 723 7711    mathias.fehr@stgag.ch   
Principal Investigator: Mathias Fehr, Prof. Dr.         
UniversitätsSpital Zürich - Klinik für Gynäkologie Recruiting
Zürich, Switzerland, 8091
Contact: Eleftherios Pierre Samartzis, Dr. med.    +41 44 255 13 88    eleftherios.samartzis@usz.ch   
Principal Investigator: Eleftherios Pierre Samartzis, Dr. med.         
Sponsors and Collaborators
NovoCure Ltd.
Investigators
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Principal Investigator: Ignace Vergote, MD University Hospitals Leuven, Leuven Cancer Institute

Publications:

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Responsible Party: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT03940196     History of Changes
Other Study ID Numbers: EF-28
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NovoCure Ltd.:
Platinum Resistant Ovarian Cancer
PROC
TTFields
Paclitaxel
Minimal toxicity
TTF
Tumor Treating Fields
Novocure
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action