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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ClinicalTrials.gov Identifier: NCT03940196 |
Recruitment Status :
Active, not recruiting
First Posted : May 7, 2019
Last Update Posted : April 20, 2022
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Condition or disease | Intervention/treatment | Phase |
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Ovarian Cancer | Device: NovoTTF-100L(O) Drug: Paclitaxel | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual 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 Recurrent Ovarian Cancer |
Actual Study Start Date : | March 22, 2019 |
Estimated Primary Completion Date : | September 2023 |
Estimated Study Completion Date : | September 2023 |

Arm | Intervention/treatment |
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Experimental: NovoTTF-100L(O)
Patients receive TTFields using the NovoTTF-100L(O) System together with weekly Paclitaxel
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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:
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Active Comparator: Best Standard of Care
Patients receive best standard of care with weekly Paclitaxel
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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:
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- Overall survival [ Time Frame: 4 years ]
- Progression-free survival [ Time Frame: 4 years ]
- Objective response rate [ Time Frame: 4 years ]
- Next progression-free survival [ Time Frame: 4 years ]Measured from the time of randomization to tumor progression on next-line treatment
- 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
- 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
- Quality of life using the EORTC QLQ C30 questionnaire with the ovarian cancer symptom OV28 module. [ Time Frame: 4 years ]
- Severity and frequency of adverse events [ Time Frame: 4 years ]

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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:
- 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

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

Principal Investigator: | Ignace Vergote, MD | University Hospitals Leuven, Leuven Cancer Institute |
Responsible Party: | NovoCure Ltd. |
ClinicalTrials.gov Identifier: | NCT03940196 |
Other Study ID Numbers: |
EF-28 |
First Posted: | May 7, 2019 Key Record Dates |
Last Update Posted: | April 20, 2022 |
Last Verified: | April 2022 |
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 |
Platinum Resistant Ovarian Cancer TTFields Paclitaxel Minimal toxicity |
TTF Tumor Treating Fields Novocure |
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases |
Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Paclitaxel Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |