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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03940196
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : January 2, 2020
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

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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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT03940196

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Contact: Antonia Mahnig

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Sponsors and Collaborators
NovoCure Ltd.
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Principal Investigator: Ignace Vergote, MD University Hospitals Leuven, Leuven Cancer Institute


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Responsible Party: NovoCure Ltd. Identifier: NCT03940196    
Other Study ID Numbers: EF-28
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 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
Minimal toxicity
Tumor Treating Fields
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action